/Product_Compendium_Ire_Collated_29-03-2012

Product Compendium (Ireland)

2012

AN IRISH OWNED COMPANY SUPPORTING LOCAL JOBS

Product Compendium (Ireland) Contents Foreward

3

Product Guide

4-11

Product Datasheets

12-119

Index of Products

120-121

Bimeda Sales Team

122

This compendium is up to date and accurate as of the date of issue (April 2012). To ensure accuracy of information subsequent to the issue date, please consult the SPC on www.imb.ie

2

Foreword Founded in Ireland in 1967, Bimeda速 has become one of the leading manufacturers and distributors of veterinary pharmaceuticals and animal health products in Ireland. We are the market originator and leader in teat seal products. Our original teat seal brand, Boviseal, is now widely used on Irish dairy farms.

This technology has fundamentally changed mastitis control programs in the Irish dairy industry. The use of Boviseal will be critical for Irish dairy farmers to meet the Food Harvest 2020 target of a 50% increase in milk production by the end of the decade. It is a good example of how an Irish company can be at the forefront of innovation to drive our Agri-food sector to be best the best in the world.

Headquartered in Dublin, our company employs over 130 people in Ireland and over 500 worldwide.

We have seven manufacturing facilities in Ireland, USA, Canada, UK and Brazil. We also distribute

in Mexico and Kenya. We have a state of the art R & D/Regulatory Laboratory in Shijiazhuang, China.

Our organisation develops and manufactures a wide range of veterinary products including; antibiotics, anti-inflammatories, intramammaries, scour treatments, ecto & endo parasiticides together with a comprehensive equine health portfolio.

Our mission is to be recognized as a market leader in the commercial and companion animal health sectors across the globe, through our people, products, and customers. We are committed to improving health and wellness of pets and livestock around the world, by providing innovative, high quality products and solutions through excellence in research and development, manufacturing and above all customer service.

Together with our customers, we aim to make the difference!

3

Code

1ABI001

1BIL001

Description ABINEX FORTE (Abamectin 10mg/ml)

BILOSIN 200 INJECTION (Tylosin 200mg/ml)

1BIM003

BIMADINE PDR (Sulfadimidine 25g)

1BIM018

1BIM027

BIMOTRIM CO. INJECTION (Sulphadoxine 200mg/ml/ Trimethoprim 40mg/ml)

BIMOXYL LA INJECTION (150mg/ml Amoxicillin)

1BIM052

1BIM068

1BIM098

1BIM123

1BIM156

1BIO001

1BOV024

1BOV010 4

BIMASTAT

Product Size 400ml, 1L, 2.5L

100ml

100 X 25g

100ml

100ml

(Sulphadiazine 150mg/ml, Neomycin 25mg/ml)

250ml, 1L

BIMECTIN INJECTION

50ml, 250ml, 500ml

(Ivermectin 10mg/ml)

BIMECTIN HORSE WORMER (Ivermectin 18.7 mg/g)

BIMECTIN POUR ON (Ivermectin 5mg/ml) Bimectin 0.5% Cattle Pour On Solution

BIMECTIN PLUS INJECTION (Ivermectin 10mg/ml, Clorsulon 100mg/ml)

BIOCOLOST B (Colostrum from selected and controlled herds)

BOVISAL PEARLS

6.42g Syringe

2.5L, 5L 50ml, 250ml, 500ml

100ml

(Calcium supplement for downer cows with added phosphorous and energy)

600g

BOVISEAL NA

120 syringes per container

(Bismuth Subnitrate 2.6g)

Species Cattle

Sheep

Equine

ctd.

Pig

Dog

Cat

Poultry

Withdrawal Categ. Period Milk

Withdrawal Period Meat

Page

Do not use on non-lactating cows or within 60 days of calving.

35 days

12

POM

Nil

21 Days

14

POM

N/A

28 Days

16

POM

48 hours

5 Days

18

POM

72 hours

Cattle 18 days Sheep 21 days Pigs 11 days

20

POM

Nil

28 Days

22

LM

Do not use on lactating cows or within 60 days of calving.

Cattle 49 days Sheep 42 days Pigs 28 days

24

LM

N/A

34 days

26

LM

Not for use in animals producing milk for human consumption

28 Days IMB 31 days

28

LM

Not for use in lactating cows or in-calf dairy stock

66 Days

30

N/A

Nil

Nil

32

N/A

Nil

Nil

34

LM

Nil

Nil

36

LM

5

Code

1BOV011

Description BOVIMAST DC (Cloxacillin 500mg)

BOVIFERM PLUS

1BOV021 1BOV022

1EQU001

1CON007

1CRO003

1CYC002

1CYC001

1CYP003

1DIP010

CALCIUM BOVISAL (Minerals containing calcium, magnesium, phosphorous)

CONVITAL EQUILYTES (Contains potassium, magnesium and calcium ions concentrated in an amino acid chelate)

CONVITAL R

(Contains 7 essential vitamins and 11 vital minerals & trace elements in a balanced ratio)

CRONYXIN INJECTION (Flunixin 50mg/ml)

CYCLOSOL SPRAY (chlorotetracycline 200mg/ml)

CYCLOSOL LA INJECTION (Oxytetracycline 200mg/ml)

CYPERGUARD (Cypermethrin High Cis 10% w/w per ml)

DIPEN (Procaine Penicillin 200mg& Dihydrostreptomycin 200mg/ml) Procaine Penicillin 200mg & Dihydrostreptomycin 200mg/m

1ECT001

(Cypermethrin Technical 2.5% w/v)

8ECT008

120 syringes per container 24 x 115g Sachets

500ml

3 X 60g

4.5L

50ml, 100ml

211ml

100ml

1L, 2L

100ml

D-MITE

TBC

1ECT003

6

(Electrolytes, dextrose, Buffering agents, lactic acid bacteria, vegetable mucins and mineral bulking agents)

Product Size

ECTOSPEC

ECTOFLITS (Diazinon 60% w/w)

ECTOFLY (Cypermethrin)

2 x 5L

500ml, 2.5L

3L

5L

Species Cattle

Sheep

Equine

ctd.

Pig

Dog

Cat

Poultry

Withdrawal Categ. Period Milk POM

Withdrawal Period Meat

Page

28 Days + 120 Hours

28 Days

38

N/A

Nil

Nil

40

N/A

Nil

Nil

42

LM

N/A

Nil

44

LM

N/A

Nil

46

POM

36 Hours

7 days.

Not to be used in horses intended for human consumption.

48

POM

Nil

Nil

50

POM

12 days

Cattle 30 days Pigs 30 days

52

N/A

14 days

54

POM

Nil 72hrs

Pigs and Cattle 21 days

56

TBC

TBC

TBC

58

LM

Nil

10 days

60

LM

N/A

35 days

62

LM

64 7

Code 1EFI001

1EMB001

1END009

1END002

1END023

1EQU005

1FLE003

1HEL002

1HYS002

Description EFICUR (Ceftiofur 50mg/ml)

EMBOTAPE HORSE WORMER (Pyrantel embonate 400mg/g)

ENDOSPEC 2.5% SC (Albendazole 25 mg, Selenium 0.27mg, Cobalt 0.24mg/ml)

ENDOSPEC 10% SC (Albendazole 100 mg/ml)

ENDOFLUKE 10 (Triclabendazole 100mg/ml)

EQUIBACTIN (Trimethoprim 66.7mg, Sulfadiazine 333.3mg/g)

FLEE (Flee Household Flea Spray)

HELODIP (Ammonium Lauryl Sulphate 3.1 % w/v)

HYSPAN 400 MG ORAL POWDER (Neomycin Sulphate 4mg/g)

KEFAMAST DRY COW

1KEF002

(Anhydrous Cefalexin 500 mg Dihydrostreptomycin 500mg/syringe)

1KEF010

(Cephalexin 500mg Dihydrostreptomycin 500mg/10ml)

KEFAMAST LACTATING COW

MULTIMAST DRY COW 1MUL004

8

(Neomycin Sulphate 100mg Penethamate Hydriodide 100mg Procaine Benzylpenecillin 400mg/4.5g syringe)

TBC

NEFOTEK (Nefotek 100 mg/ml solution for injection)

1OSM004

(Contains 1.99% w/w of available Iodine)

OSMODEX

Product Size 100ml

28.5g

2.5L, 5L

1L, 2.5L, 5L

1L, 2.5L

45g Syringe

400ml

5L, 20L

100g Sachets

120 syringes per container 24 syringes per container 120 syringes per container

100ml, 250ml

5L, 25L

Species Cattle

Sheep

Equine

ctd.

Pig

Dog

Cat

Poultry

Withdrawal Categ. Period Milk

Withdrawal Period Meat

Page

POM

Nil

Pigs and Cattle 2 days 8 days

66

LM

N/A

7 Days

68

LM

60 Hours

Sheep 4 Days Cattle 14 days

70

LM

60 hours

Cattle: 14 days Sheep: 4 days

72

LM

Not permitted for use in lactating cows.

56 days

74

POM

N/A

14 Days

76

POM

N/A

N/A

78

LM

Nil

Nil

80

POM

N/A

28 Days

82

POM

40 Days + 60 hours

28 days

84

POM

96 hours

7 days

86

POM

50 days + 96 hours

28 days

88

N/A

N/A

90

LM

92 9

Code

Description

1OXY003

(Oxytetracycline hydrochloride equivalent to Oxytetracycline 10mg. Flunixin Meglumine equivelant to Flunixin 20mg/ml)

1OXY037

1RAP001

OXYCOMPLEX NS INJECTION

OXYTOCIN INJECTION (synthetic) 10 I.U. per ml

RAPIDEXON 2MG INJECTION (Dexamethasone 2mg/ml)

SEDAXYLAN INJECTION

1SED001

(Xylazine 20mg Equivelant to 23.32mg xylazine hydrochloride/ml)

1SEL001

(Florfenicol 300mg/ml)

1SUL003

1TET015

SELECTAN INJECTION

SULPHADIMIDINE PDR (Sulfadimidine Sodium 1000mg/g)

TETROXY LA INJECTION (Oxytetracycline Ph. Eur. 200 mg/ml)

1TON002

TONAVET (Multivitamin tracel element tonic for animals)

1TYL009

TYLOVET 20% INJECTION (Tylosin 200mg/ml)

1UNI001

UNISOL (Enrofloxacin 100mg/ml)

1VET005

VETRISUL (Trimethoprim 40g, Sulphamethoxazole 200mg/ml)

VITAMIN B1 INJECTION

1VIT001

(Thiamine Hydrochloride Ph. Eur. 100 mg/ml)

1VIT014

(Phytomenadione 10mg/ml)

10

Product Size

VITAMIN K1 INJECTION

100ml

50ml

100ml

25ml

100ml

25g Sachets

100ml

500ml, 2.5L

100ml

100ml

100ml

50ml

50ml

Species Cattle

Sheep

Equine

ctd.

Pig

Dog

Cat

Poultry

Withdrawal Categ. Period Milk

Withdrawal Period Meat

Page

POM

5 Days

28 days

94

POM

Nil

Nil

96

POM

72 hours

Cattle 7 days Pig 2 days Horse 11 days

98

POM

Nil

1 day

100

POM

Not permitted for use in lactating animals producing milk for human consumption

Cattle 30 days Pigs 18 days

102

POM

5 Days

Cattle 21 days Poultry 14 days

104

POM

7 days

Cattle & Sheep 28 Days Pigs 21 days

106

Nil

Nil

108

POM

4 days

21 days

110

POM

Cattle Subcut. 84 hrs, Intraven. 72 hrs

Cattle Subcut. 13 days, Intraven. 4 days Pigs intramus.

10 days

112

POM

Cattle 5 days

Cattle 35 days

114

POM

Nil

Nil

116

POM

7 days

28 days

118

N/A

11

PRODUCT INFORMATION

ABINEX FORTE Abamectin 1% w/v INDICATIONS • Broad spectrum Endectocide containing Abamectin Forte 1% w/v • Pour on formulation for the treatment and control of external and internal parasites sensitive to avermectin family in cattle, including immature and mature roundworms and lungworms • Also for the treatment and control of biting and sucking lice • Has up to eight weeks persistent activity

BENEFITS • New generation endectocide, 1% Abamectin Pour on • Low volume dose, 1ml/20kg • Long acting 8 week activity • Rain resistant • 2.5L treats 200 x 250kg animals

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

1ABI001

400ml

CASE SIZE 6

1ABI002

1L

12

1ABI003

2.5L

6

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 12

www.bimeda.ie

TECHNICAL INFORMATION

ABINEX FORTE POUR-ON Abamectin 1% w/v Presentation A clear, straw coloured oily pour on solution containing Abamectin 1% w/v.

Uses A broad-spectrum endectocide of the avermectin family, effective against internal and external parasites sensitive to this family.

For the treatment and control of the following mature and immature roundworms and lungworms in cattle: Haemonchus spp., Ostertagia spp., Cooperia spp., Trichostrongylus spp., Oesophagostomum spp., Nematodirus spp., Trichuris spp. (adults only) Dictyocaulus spp. Also for the treatment and control of sucking and biting lice (Linognathus vituli and Damalinia bovis respectively).

Dosage and Administration Shake well before use. Abinex Forte Pour-on is ready to use through standard pour-on equipment Cattle: ml/20 kg body weight (based on the recommended dose of 500 micrograms of abamectin per kg body weight) poured on the mid-back of the animal if using the 200 ml pump pack, the measuring cup on the 400ml pack or if using a pour-on gun attached to the specially made container cap. Using the 200ml pump pack, 1 stroke per 44kg bodyweight.

To obtain maximum benefit from the persistent activity of Abinex Forte Pour-On, calves which are setstocked in their first grazing season should be treated at turn-out and at 8 week intervals

Rain Resistance Clinical trials have shown that the efficacy of Abinex Forte Pour-on is not affected by simulated rainfall 1 hour after treatment, based on faecal egg counts 3 weeks after treatment. It is advised not to treat cattle when the hide or hair is wet.

Contra-indications, Warnings, etc.

Do not concurrently treat animals with drugs, which can increase GABA activity such as barbital.

Do not treat animals with a known hypersensitivity to the active ingredient.

Assess body weight as accurately as possible before calculating dosage. Intensive use or misuse of anthelmintics may give rise to drug resistance. To reduce this risk, dosing programs should be discussed with your veterinary surgeon.

Do not use in cattle producing milk for human consumption.

Overdose Trials showed that a dose of 1000 mg/kg single or repeated after 21 days caused no ADRs, however several fold overdose of the injectable formulation of abamectin can cause toxicity; animals will become recumbent within 24 hours and may not recover; there is no antidote.

Operator Warnings Avoid contact with the skin.

Do not smoke or eat while handling the product.

The use of plastic gloves is advised.

Wash hands after use.

Do not use in other species.

If the drug is taken by mistake immediately seek medical treatment. Emetine or ephedrine may be useful.

Pharmaceutical Precautions Do not store above 25째C. Protect from light Shake well before use.

Keep out of reach and sight of children.

Abamectin should not enter watercourses as it is extremely dangerous to fish and aquatic life. Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste under national waste disposal regulations.

Legal Category

LM

Package Quantities 400ml pump pack, 1L and 2.5L VPA 10126/66/1

Withdrawal Periods Cattle must not be treated within 35 days of slaughter for human consumption. Do not use in cows producing milk for human consumption.

Do not use in non-lactating dairy cows, including pregnant heifers within 60 days of calving.

www.bimeda.ie 13

PRODUCT INFORMATION

BILOSIN 200 Tylosin 200mg INDICATIONS Bilosin 200 is indicated for the treatment of diseases involving bacteria sensitive to Tylosin Including; • Enzootic Pneumonia • Swine Dysentry • Erysipelas • Respiratory diseases • Secondary bacterial infection to virus disease • Infectious Arthritis • Cellulitis • Otitis • Mastitis • Genito-Urinary infections

BENEFITS • Tylosin base injection • Excellent syringability • Effective against a wide range of Gram-negative and Gram-postive organisms

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

1BIL001

100ml

12

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 14

www.bimeda.ie

TECHNICAL INFORMATION

BILOSIN 200 INJECTION Presentation A clear yellow sterile solution suitable for parenteral administration. Each ml contains 200mg Tylosin Base BP(Vet). Also contains Benzyl Alcohol 4% as a preservative.

Uses For the treatment of diseases in pigs involving organisms sensitive to Tylosin, including swine erysipelas (Erysipelothrix rhusiopathiae) vibrionic dysentery and pneumonia (Mycoplasma hyopneumoniae).

Dosage and Administration 0.5ml/10kg bodyweight, equivalent to 10mg of Tylosin per kg bodyweight, by intramuscular injection every 12 hours, up to a maximum of 6 injections. Do not inject more than 5ml at a single injection site. If a larger injection volume is necessary, it should be divided and administered at different injection sites.

Pharmaceutical Precautions Do not store above 25°C. Keep out of reach and sight of children.

Following withdrawal of the first dose, use the product within 28 days.

Avoid the introduction of contamination during use.

Should any apparent growth or discoloration occur, the product should be discarded.

Legal Category POM Package Quantities Multi-dose vials of 100ml.

VPA 10126/40/1 TECHNICAL INFORMATION BimedaÂŽ a division of the Cross Vetpharm Group Ltd. Broomhill Road

Contra-indications, Warnings, etc.

Do not use in animals known to be hypersensitive to the active ingredient.

Avoid skin contact with the preparation.

Wash hands after use.

Withdrawal Periods Pigs must not be slaughtered for human consumption during treatment. Pigs may be slaughtered for human consumption only after 21 days from the last treatment.

www.bimeda.ie 15

PRODUCT INFORMATION

BIMADINE PDR Sulfadimidine 25g INDICATIONS • Indicated in monogastric calves for the treatment and control of diseases caused by or associated with organisms sensitive to sulfadimidine

BENEFITS • Broad spectrum treatment and control of diseases in calves • Powerful action of sulfadimadine, effective against a wide range of pathogens • Readily soluble in water for ease of administration

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

1BIM003

25g

100

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 16

www.bimeda.ie

TECHNICAL INFORMATION

BIMADINE POWDER Sulfadimidine 25g Presentation White polythene/aluminium sachets containing a white or almost white powder which is intended, following suspension in drinking water, for oral administration to animals. Each sachet contains Sulfadimadine 99.01%w/w.

Uses For the treatment and control of diseases in monogastric calves caused by or associated with organisms sensitive to sulfadimadine.

Dosage and Administration For oral administration.

Recommended dosage 2g per 10kg bodyweight (equivalent to 1 sachet per 125 kg bodyweight), followed by daily doses of 1g per 10kg bodyweight (equivalent to 1 sachet per 250 kg bodyweight) for a further 2 days only.

Withdrawal Periods Animals must not be slaughtered for human consumption during treatment. Animals may be slaughtered for human consumption only after 28 days from the last treatment.

Pharmaceutical Precautions Keep out of reach and sight of children. Do not store above 25째C. Legal Category POM Package Quantities 100 x 25g packs.

VPA 10126/27/1

Contra-indications, Warnings, etc.

For animal treatment only.

Not to be used in animals known to be hypersensitive to the active ingredient. The procaine of procaine penicillin and local anaesthetics of the procaine group are antagonistic and should not be used during treatment. There is interaction and antagonism between sulfonamides and vitamin B complex. As with all sulphonamides, prolonged treatment may give rise to Vitamin K deficiency, agranulocytosis and haemolytic anaemia and should therefore be avoided.

www.bimeda.ie 17

PRODUCT PRODUCT INFORMATION

BIMOTRIM CO INJECTION INDICATIONS For use in cattle and horses Contains Sulfadoxine and Trimethoprim members of sulphonamide family of antibiotics.

Trimethoprim potentiates bacterostatic effect of sulpadoxine.

Active against gram negative and gram positive bacteria.

Suitable for use againist a wide range of diseases and conditions.

Effective against a wide spectrum of bacteria including: Staphylococcus sp, Streptococcus sp, Escherichia coli, Klebsiella sp, Proteus sp, Salmonella, Pasteurella and Arcanobacter pyogenes.

BENEFITS • Synergistic combination of Sulphadoxine and Trimethoprim, for enhanced antibacterial activity • Active against Gram-negative and Gram-positive organisms • Wide species protection • Indicated for the treatment of a range of diseases • Short withdrawals

PACKAGING

Bimeda®® Bimeda Broomhill Broomhill Road Road Tallaght Tallaght Dublin 24, Ireland Dublin 24, Ireland Tel: 1850-515253 Fax: 01 451 5803 Tel: 1850-515253 18

LIST NO.

UNIT PACKAGE

CASE SIZE

1BIM018

100 ml

12

See reverse side for Administration and Dosage.

www.bimeda.ie www.bimeda.ie

TECHNICAL TECHNICAL INFORMATION INFORMATION

BIMOTRIM CO INJECTION PRESENTATION A clear, pale pink/brown sterile, aqueous solution for parenteral administration.

Each ml contains: 200mg Sulfadoxine and 40mg Trimethoprim.

TARGET SPECIES Cattle and horses.

INDICATIONS FOR USE The in vitro activity covers most common Gram-positive and Gram-negative bacteria including Actinobacillus spp., Actinomyces bovis, Bordetella spp., Corynebacterium spp., Klebsiella spp., Listeria monocytogenes, Nocardia spp., Pasteurella spp., Proteus spp., Salmonella spp., Staphylococcus spp., and Streptococcus spp.

Indications: The injection may be used in the treatment of a wide range of diseases and conditions of bacterial origin in cattle and horses.

Respiratory infections of bacterial origin including pneumonia, rhinitis, bronchitis and secondary bacterial infections following virus pneumonia mycoplasmal infections.

Urogenital tract infections including cystitis, vaginitis, urethritis, nephritis and metritis.

Alimentary tract infections, neonatal diarrhoea, salmonellosis and post- weaning enteritis.

CONTRAINDICATIONS Do not administer by the intraperitoneal or subcutaneous route.

Do not administer to horses exhibiting cardiac arrhythmias.

Such arrhythmias may be associated with the administration of certain anaesthetic and sedative agents.

SPECIAL WARNINGS FOR EACH TARGET SPECIES Very occasionally, temporary irritating swellings may appear at the site of injection.

SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals The following warnings are applicable to all Trimethoprim Sulfonamide combinations for use in the horse.

1. Cardiac and respiratory shocks in horses have been observed, mostly after intravenous injection.

2. The injection solution should be approximately intolerance, the injection should be interrupted and shock treatment initiated. The product should be injected slowly over as long a period as is reasonably practical.

3. The intravenous route of administration is contra-indicated in the case of previous or concurrent administration of central nervous system depressants (e.g. anaesthetics, neuroleptics).

4. The possibility of an anaphylactic or hypersensitivity reaction occurring following administration on rare occasions must be borne in mind.

5. As with all trimethoprim sulphonamide formulations the possibility of potential damage to the kidney or liver or haematopoetic system should be considered

(ii) Special precautions to be taken by person administering the medicinal product Care should be taken to avoid accidental injection and contact with the skin. Wash hands after use.

Sulphonamides may cause hypersensitivity (allergy) following, injection, inhalation, ingestion or skin contact. Hypersensitivity to sulphonamides may lead to cross reactions with other antibiotics.

Allergic reactions to these substances may occasionally be serious.

1. Do not handle this product if you know you are sensitive to sulphonamides.

2. If you develop symptoms following exposure such as skin rash, you should seek medical advice and show the doctor this warning.

ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Very occasionally, temporary irritating swellings may appear at the site of injection.

USE DURING PREGNANCY AND LACTATION Studies during pregnancy have not been conducted. Use with care in pregnant animals.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS Because of the competitive action of the sulphonamides, their activity may be antagonised by the presence of any of the following: 1. para-Aminobenzoic acid (PABA) and related compounds, particularly local anaesthetics with a PABA nucleus such as procaine, butacaine and benzocaine, but also compounds associated with those such as procaine penicillin.

It is recommended that local anaesthetics of the procaine group should not be used during treatment with Bimotrim Co Injection.

2. Some members of the Vitamin B complex, such as nicotinamide, folic acid, choline and precursors of these.

3. Proteins which combine loosely with the sulphonamides and at least temporarily reduce their antibacterial activity. Gelatin, albumin, peptone and serum protein all antagonise the sulphonamides. Associated with this group are products of cell and tissue death, especially pus, which also acts as a non-vascular, mechanical barrier.

4. A number of other compounds, including enzymes, glucose and mercuric chloride, are all reported AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE Dose: 15mg/kg (equivalent to 1 ml per 16 kg bodyweight) daily. Daily dosing should be repeated for two days after symptoms have resolved up to a maximum of 5 days.

Route of administration: Cattle: By slow intravenous or intramuscular injection. Intramuscular injection is the preferred route and should be given into the neck.

Horses: By slow intravenous injection.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES), IF NECESSARY Do not exceed the recommended dose or treat animals for more than 5 consecutive days.

WITHDRAWAL PERIOD(S) Milk for human consumption must not be taken during treatment.

With cows milked twice daily, milk for human consumption may only be taken from 60 hrs. (i.e. 5th milking) from the last treatment.

With other milking routines, milk may be taken for human consumption only after the same period from last treatment (e.g. with 3 times a day milking, milk for human consumption may only be taken at the 8th milking).

Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 10 days from last treatment.

Not to be used in horses intended for human consumption.

Treated horses may never be slaughtered for human consumption.

The horse must have been declared as not intended for human consumption under national horse passport legislation.

6.2 Incompatibilities (major) None known.

6.3 Shelf Life, when necessary after reconstitution of the product or when the (a) Shelf-Life of the veterinary medicinal product as packaged for sale: 2 years. (b) Shelf-life after opening the immediate packaging: 28 days.

SPECIAL PRECAUTIONS FOR STORAGE Do not freeze.

Do not store above 25째C. Protect from light. product within 28 days.

Discard unused material.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM THE USE OF SUCH PRODUCTS IF APPROPRIATE Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

MARKETING AUTHORISATION HOLDER Bimeda Chemicals Ltd., Broomhill Road, Tallaght, Dublin 24. Ireland.

MARKETING AUTHORISATION NUMBER VPA 10126/020/001 LEGAL CATEGORY

POM-V PACKAGE QUANTITIES Multi-dose 100ml vials A full product SPC is available on request from Bimeda or alternatively can be found on the IMB website

www.bimeda.ie www.bimeda.ie

19

PRODUCT PRODUCT INFORMATION

BIMOXYL L.A. INJECTION 150mg Amoxicillin/ml INDICATIONS Contains amoxicillin which is a member of the penicillin family.

Cattle and Sheep: For the control and treatment of respiratory and other infections caused by amoxycillin susceptible bacteria only.

Pigs: For the treatment of infectious diseases in pigs caused by or associated with organisms sensitive to amoxycillin.

Dogs: For the treatment of infectious diseases in dogs caused by or associated with organisms sensitive to amoxycillin

BENEFITS • Rapid absorption due to the patented penetration enhancer incorporated into the formulation • Starts to work straight away with prolonged activity for 48 hours • Well tolerated in cattle, sheep pigs and dogs.

• Broad spectrum antibiotic offering cover against Gram-negative and Gram-positive organisms • Effective against diseases of the respiratory, alimentary and urogenital tracts • Widespread tissue distribution • Excellent syringeability via 21 gauge needle • Single shot treatment in most cases

Bimeda®® Bimeda Broomhill Broomhill Road Road Tallaght Tallaght Dublin 24, Ireland Dublin 24, Ireland Tel: 1850-515253 Fax: 01 451 5803 Tel: 1850-515253 20

PACKAGING LIST NO.

UNIT PACKAGE

CASE SIZE

1BIM028

100 ml

12

See reverse side for Administration and Dosage.

www.bimeda.ie www.bimeda.ie

TECHNICAL TECHNICAL INFORMATION INFORMATION

BIMOXYL L.A. INJECTION 150mg Amoxicillin/ml

PRESENTATION A Sterile, off-white, oily, injectable suspension.

Each ml contains 150mg Amoxicillin ( as amoxicillin trihydrate) TARGET SPECIES Cattle, sheep, pigs and dogs.

INDICATIONS FOR USE Cattle and Sheep: For the control and treatment of respiratory and other infections caused by amoxicillin susceptible bacteria only.

Pigs: For the treatment of infectious diseases in pigs caused by or associated with organisms sensitive to amoxicillin.

Dogs: For the treatment of infectious diseases in dogs caused by or associated with organisms sensitive to amoxicillin.

CONTRAINDICATIONS Not suitable for intravenous or intrathecal administration.

Not to be administered to small herbivores.

Do not use in known cases of hypersensitivity to beta-lactam antibiotics.

SPECIAL WARNINGS FOR EACH TARGET SPECIES Not effective against Beta-lactamase producing organisms.

SPECIAL PRECAUTIONS FOR USE (i) Precautions for use in animals Routine aseptic precautions should be taken. (ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross-reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.

Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.

Handle this preparation with great care to avoid exposure, taking all recommended precautions.

If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the Doctor this warning. with breathing are more serious symptoms and require urgent medical attention.

ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) As with all penicillins, amoxicillin may cause hypersensitivity (allergy) and should not be used when an animal is known to be allergic to beta-lactams.

Occasional local reaction of a transient nature may occur at the site of injection.

USE DURING PREGNANCY, LACTATION OR LAY As with all other antibiotics, Bimoxyl LA should be used with caution during pregnancy and lactation. There is no evidence that the use of amoxicillin presents any particular hazard either to the dam or to the foetus.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION with any other drugs commonly administered to animals.

It is not recommended to administer bactericidal and bacteriostatic antibiotics concomitantly.

AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE This product does not contain an antimicrobial preservative. Use a dry, sterile needle and syringe. Swab the septum before removing each dose. Shake the vial well before use.

Cattle, Sheep & Pigs: By intramuscular route only.

Dogs: By subcutaneous injection.

The injection site should be massaged after injection.

The recommended dosage rate is 15 mg amoxicillin per kg bodyweight. This is equivalent to 1 ml/10 kg.

One repeat administration may be given after 48 hours.

The maximum injection volume at any one site is: Cattle: 20 ml; Sheep: 4 ml; Pigs: 5 ml; Dogs: 2.5 ml.

Larger dose volumes should be divided and given into separate sites.

Use a dry syringe for extraction of suspension to avoid hydrolysis of amoxicillin.

An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES), IF NECESSARY The safety of amoxicillin is typical of that of other penicillins in that intrinsic toxicity is very Beta-lactams, and this seems rare. Tolerance studies at twice the normal recommended dose in the named target species have been carried out

WITHDRAWAL PERIOD(S) i) Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 21 days from the last treatment.

Sheep may be slaughtered for human consumption only after 25 days from the last treatment.

Pigs may be slaughtered for human consumption only after 13 days from the last treatment. ii) Milk for human consumption must not be taken during treatment. Milk for human consumption may be taken only from cattle after 156 hours from the last treatment. iii) Not for use in ewes producing milk for human consumption or food processing.

MAJOR INCOMPATIBILITIES Exposure to moisture will lead to hydrolysis of the active substance.

SHELF LIFE 2 Years. product within 28 days.

SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25째C. Protect from light.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIALS DERIVED FROM THE USE OF SUCH PRODUCTS IF APPROPRIATE Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

MARKETING AUTHORISATION HOLDER Bimeda Chemicals Ltd., Broomhill Road, Tallaght, Dublin 24. Ireland.

MARKETING AUTHORISATION NUMBER VPA10126/009/001 LEGAL CATEGORY POM

PACKAGE QUANTITIES Multidose vials of 100ml A full product SPC is available on request from Bimeda or alternatively can be found on the IMB website

www.bimeda.ie www.bimeda.ie

21

PRODUCT INFORMATION

BIMASTAT Sulfadiazine 150mg/ml Neomycin 25mg/ml INDICATIONS • Oral Solution containing sulfadiazine, a sulphonamide antibiotic and neomycin, an aminoglycoside antibiotic • Also contains Kaolin • For the treatment or diarrhoea in pre- ruminant calves associated with infections caused by organisms known to be, or suspected of being, susceptible to the combination of sulfadiazine and neomycin

BENEFITS • Unique formulation scour treatment in a distinctive pink colour for calves • Broad spectrum activity against a wide range of pathogens • Contains the powerful antibiotic Neomycin, with Sulphadiazine and Kaolin • Immediate response seen in calf after first treatment • Dosage syringe supplied in each pack

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

1BIM052

250ml

12

1BIM053

1L

10

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 22

www.bimeda.ie

TECHNICAL INFORMATION

BIMASTAT Presentation A light pink coloured oral suspension, containing Neomycin base 2.5% w/v, Sulfadiazine 15.0% w/v and Light Kaolin 10.5% w/v. Also contains Methyl parahydroxybenzoate and Propyl parahydroxybenzoate as preservatives and E122(colouring agent).

Uses For the oral treatment of undifferentiated diarrhoea in pre-ruminant calves only.

Dosage and Administration For oral administration only.

Shake well before use.

Recommended dose: 4ml per 10kg body weight twice daily. This equates to 60mg/kg sulfadiazine, 10mg/kg neomycin and 42mg/kg kaolin twice daily.

The maximum period of treatment is 5 days.

Contra-indications, Warnings, etc.

For animal treatment only.

Do not exceed the recommended dosage or period of treatment.

Do not use in lactating cows.

Do not use in foals and horses.

Not suitable for calves with functional rumens.

Not to be used in animals known to be hypersensitive to any of the active ingredients.

Do not use local anaesthetics of the procaine group during treatment, as they are antagonistic to the sulphonamide component.

Chronic usage of oral neomycin may result in bacterial or fungal superinfections.

Concurrent intravenous fluid therapy should be considered in dehydrated calves. Parenteral antibiotic treatment should be considered if a clinical response is not seen after 48 hours treatment.

Withdrawal Periods Animals intended for human consumption must not be slaughtered during treatment.

Calves intended for human consumption may only be slaughtered after 28 days from the last treatment. Not intended for animals producing milk for human consumption.

Pharmaceutical Precautions Avoid contact with skin. Wash hands after use.

Do not store above 25째C. Keep out of reach and sight of children.

Legal Category POM Package Quantities 250ml and 1 Litre VPA No 10960/21/1

www.bimeda.ie 23

PRODUCT PRODUCT INFORMATION

BIMECTIN INJECTION Ivermectin 1% w/v INDICATIONS Contains 1% ivermectin w/v Licenced for Cattle, Sheep and Pigs.

Cattle Licenced for wide range of internal and external Parasites.

Sheep Licenced for a wide range of Gastro-Intestinal worms, Lungworms and Nasal Bots.

Pigs Licenced for a wide range of external and Internal parasites.

BENEFITS • Antiparastic injectable solution • Delivers effective control against a wide range of external and internal parasites • Penetrates quickly to reach and kill parasites • Licenced for cattle, sheep and pigs • Cost effective parasitic control in animals • 1 x 500ml pack can treat; 333 x 50-75kg ewes, or 62 x 400kg cattle, or 125 x 100- 133kg pigs

PACKAGING

Bimeda®® Bimeda Broomhill Broomhill Road Road Tallaght Tallaght Dublin 24, Ireland Dublin 24, Ireland Tel: 1850-515253 Fax: 01 451 5803 Tel: 1850-515253 24

LIST NO.

UNIT PACKAGE

CASE SIZE

1BIM075

250ml

6

1BIM076

500ml

6

See reverse side for Administration and Dosage.

www.bimeda.ie www.bimeda.ie

TECHNICAL TECHNICAL INFORMATION INFORMATION

BIMECTIN INJECTION Ivermectin 1% w/v PRESENTATION A clear, colourless slightly viscous, non-aqueous sterile solution containing 1% w/v Ivermectin.

TARGET SPECIES Cattle, Sheep and Pigs.

INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the effective treatment and control of the following harmful parasites of cattle, sheep and pigs: Cattle Gastrointestinal roundworms (adult and fourth-stage larvae): Ostertagia spp. (including inhibited O. ostertagi) Haemonchus placei Trichostrongylus axei T. colubriformis Cooperia spp.

Bunostomum phlebotomum Oesophagostomum radiatum Strongyloides papillosus (adult) Nematodirus helvetianus (adult) N. spathiger (adult) Trichuris spp (adult).

Lungworms (adult and fourth-stage larvae): Dictyocaulus viviparus Eye worms (adult): Thelazia spp.

Warbles: Hypoderma bovis H. lineatum Mange mites: Psoroptes bovis Sarcoptes scabiei var. bovis Suckling lice: Linognathus vituli Haematopinus eurysternus Solenopotes capillatus May also be used as an aid in the control of the mange mite Chorioptes bovis and biting lice Damalinia bovis, but complete elimination may not occur.

Persistent Activity Treatment at the recommended dose rate can control re-infection with Haemonchus placei and Cooperia spp. acquired up to 14 days after treatment, Ostertagia ostertagi and Oesophagostomum radiatum acquired up to 21 days after treatment and Dictyocaulus viviparus up to 28 days after treatment. the product for grazing animals, it is recommended that should be treated 3, 8 and 13 weeks after the day of turn-out. This can protect the animals from parasitic gastroenteritis and lungworm disease throughout the grazing season, provided they are set-stocked, all the calves included in the programme and that no untreated cattle are added to the pasture. Treated animals should always be monitored according to good husbandry practices.

Sheep Gastrointestinal roundworms (adult and fourth-stage larvae): Ostertagia circumcincta including inhibited larvae O. trifurcata Haemonchus contortus including inhibited larvae Trichostrongylus axei (adults) T. colubriformis and T. vitrinus (adults) Cooperia curticei Oesophagostomum columbianum O. venulosum (adults) Chabertia ovina Trichuris ovis (adults).

Lungworms: (adult and fourth-stage larvae) Protostrongylus rufescens (adults) Nasal Bots (all larval stages) Oestrus ovis Pigs Gastrointestinal roundworms (adult and fourth-stage larvae): Ascaris suum Hyostrongylus rubidus Oesophagostomum spp.

Strongyloides ransomi (adult and somatic larval stages) Lungworms: Metastrongylus spp. (adults) Lice: Haematopinus suis Mange mites: Sarcoptes scabiei var. suis

CONTRAINDICATIONS Do not use in animals with known hypersensitivity to the active ingredient.

Do not use by intramuscular or intravenous administration.

SPECIAL WARNINGS FOR TARGET SPECIES None.

SPECIAL PRECAUTIONS FOR USE (i) Special Precautions for use in animals cattle, sheep and pigs. It should not be used in other species as severe adverse reactions, including fatalities in dogs, may occur.

Frequent and repeated use may lead to the development of resistance. It is important that the correct dose is given in order to minimise the risk of resistance. To avoid under-dosing, animals should be grouped according to their bodyweight and dosed according to the dose of the heaviest animal in the group. (ii) Special Precautions to be taken by the Person Administering the Product to Animals Take care to avoid self-administration: the product may cause local irritation and/or pain at the site of injection.

Direct contact of the product with the skin should be kept to a minimum.

Do not smoke or eat while handling the product. Wash hands after use. (iii) Other precautions When using the 250 ml and 500 ml pack sizes, use only a draw off needle is recommended to avoid excessive broaching of the stopper.

ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Cattle Transient discomfort has occasionally been observed in cattle following subcutaneous administration. A low incidence of soft tissue swelling at the injection site has been observed.

Sheep Discomfort, sometimes intense but usually transient, has been observed in some sheep immediately following subcutaneous administration.

Pigs Mild and transient discomfort has occasionally been observed in pigs following subcutaneous injection.

All these reactions disappeared without treatment.

USE DURING PREGNANCY AND LACTATION OR LAY The product can be administered to beef cows, sheep and pigs at any stage of pregnancy Lactation Do not use in dairy cows or sheep producing milk for human consumption.

Do not use in non-lactating dairy cows or sheep within 60 days of calving/lambing. The product can be used in sows during lactation.

Fertility Fertility is not affected by administration of the product.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION The product can be used concurrently without adverse effects with foot and mouth disease vaccine or clostridial vaccine, given at separate injection sites.

AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE The product should be given only by subcutaneous injection at the recommended dosage level of 200 mcg ivermectin per kg bodyweight under the loose skin in front of, or behind, the shoulder in cattle and over the neck in sheep. At the recommended dosage level of 300 mcg ivermectin per kg of bodyweight, the product should be given only subcutaneously in the neck of pigs.

50 kg of bodyweight of cattle and sheep and 33 kg of bodyweight of pigs.

The injection may be given with any standard automatic or single-dose or hypodermic syringe.

Use of a sterile 17 gauge x ½ inch needle is suggested.

Injection of wet or dirty animals is not recommended.

If using a single-dose or hypodermic syringe, use a separate sterile needle to withdraw the product from the container. Massage the injection site after administration of the product.

In young pigs, especially those below 16 kg for which less than 0.5 ml of the product is indicated, dosing accuracy is important.

The use of a syringe that can accurately deliver as little as 0.1 ml is recommended.

In young lambs weighing less than 20.0 kg give 0.1 ml per 5 kg. In these lambs the use of a syringe with can deliver as little as 0.1 ml is recommended.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES), IF NECESSARY Cattle Single doses of 4.0 mg ivermectin per kg (20 x the use level) given subcutaneously resulted in ataxia and depression.

Sheep At dose levels up to 4 mg ivermectin per kg (20 x the use level) given subcutaneously resulted in ataxia and depression. No signs of systemic toxicity were observed in sheep treated with the product at up to 3 times the recommended dose rate, soft tissue swellings at the injection site were observed.

Pigs A dose of 30 mg ivermectin per kg (100 x the recommended dose of 0.3 mg per kg) injected subcutaneously to pigs caused lethargy, ataxia, bilateral mydriasis, intermittent tremors, laboured breathing and lateral recumbancy.

In the case of overdosage, symptomatic treatment should be given.

WITHDRAWAL PERIOD(S) Cattle Meat and Offal – 49 days. Do not use in lactating cows producing milk for human consumption. Do not use in non-lactating dairy cows including pregnant dairy heifers within 60 days of calving.

Sheep must not be treated within 42 days of slaughter for human consumption. Do not use in lactating sheep producing milk for human consumption. Do not use in sheep within 60 days of lambing where milk is to be used for human consumption.

Pigs must not be treated within 28 days of slaughter for human consumption.

INCOMPATIBILITIES Do not mix with other medicinal products.

SHELF LIFE Shelf-life of the veterinary medicinal product as packaged for sale: 3 years 28 days.

SPECIAL PRECAUTIONS FOR STORAGE None.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIAL, IF ANY Any unused veterinary product or waste material derived from the product should be disposed of in accordance with local requirements. The product should not enter other aquatic organisms.

MARKETING AUTHORISATION HOLDER Bimeda Chemicals Ltd., Broomhill Road, Tallaght, Dublin 24. Ireland.

MARKETING AUTHORISATION NUMBER VPA 1096/033/001 LEGAL CATEGORY

POM PACKAGE QUANTITIES 250ml, 500ml A full product SPC is available on request from Bimeda or alternatively can be found on the IMB website

www.bimeda.ie www.bimeda.ie

25

PRODUCT INFORMATION

BIMECTIN ORAL PASTE Ivermectin 18.7mg/g INDICATIONS Bimectin is indicated for the treatment of nematode or arthropod infestations in horses due to: • Large strongyles • Small Strongyles • Lungworms (adult and immatures) • Pinworms (adult and immatures) • Ascarids (adults and third & fourth stage larvae) • Hairworms (adults) • Large-mouth stomach worms (adults) • Neck threadworms (microfilariae) • Intestinal threadworms (adults) • Stomach bots (oral and gastric stages) • Ivermectin is not effective against the encysted larval stages of the small strongyles

BENEFITS • Gel formulation for ease of dose and absorption • Apple flavoured for exceptional palatibility • Calibrated syringe for accurate dosage • Broad spectrum ivermectin anthelmintic and boticide • Proven safe in horses of all ages • Broad spectrum activity agaist a wide range of debilitating and performance robbing parasites

Bimeda® Broomhill Road

PACKAGING LIST NO.

UNIT PACKAGE

CASE SIZE

1BIM098

6.42g

24

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 26

www.bimeda.ie

TECHNICAL INFORMATION

BIMECTIN HORSE PASTE Presentation A yellow gel-like, apple flavoured, paste of uniform consistency, containing 1.87% w/w Ivermectin.

Uses Bimectin Horse Paste is indicated for the treatment nematode or arthropod infestations in horses due to: Large strongyles: Strongylus vulgaris (adults and 4th larval [arterial] stages), S. edentatus (adults & 4th larval [tissue] stages), S. equinus (adults), Triodontophorus spp. (adults), Triodontophorus brevicauda, Triodontophorus serratus. Small Strongyles: Adult and immatures (fourth stage larvae) small strongyles or cyathostomes unless otherwise stated. Ivermectin is not effective against the encysted larval stages of the small strongyles.: Coronocyclus spp., Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., , Parapoteriostomum spp., Petrovinema spp., Poteriostomum spp.

Lungworms (adult andinhibited fourth stage larvae): Dictyocaulus arnfieldi Pinworms (adult and inhibited fourth stage larvae): Oxyuris equi Ascarids (adults and third & fourth stage larvae): Parascaris equorum Hairworms (adults): Trichostrongylus axei Large-mouth stomach worms (adults): Habronema muscae Neck threadworms (microfilariae): Onchocerca spp. Intestinal threadworms (adults): Strongyloides westeri Stomach bots: Oral and gastric stages of Gasterophilus spp.

Dosage and Administration Administer orally as a single dose rate to horses at the recommended dose level of 0.2mg ivermectin per kilogram of bodyweight. Each syringe delivers 120mg ivermectin, sufficient to treat 600kg of bodyweight. Single administration.

Bodyweight and dosage should be accurately determined prior to treatment.

Dosing Instructions Each weight marking on the syringe plunger will deliver sufficient paste to treat 100kg bodyweight. Unlock the knurled ring by making ¼ turn and slide the knurled ring up the plunger shaft so that the side nearest the barrel is at the prescribed weight

marking. Turn the knurled ring ¼ turn to lock in place. Make sure the horse’s mouth contains no feed. Remove the plastic cap from the tip of the nozzle. Insert the syringe into the horse’s mouth at the inter-dental space. Advance the plunger as far as it will go, depositing the medication on the base of the tongue. Immediately raise the horse’s head for a few seconds after dosing. The treatment schedule should be based on the local epidemiological situation.

Contra-indications, Warnings, etc Special warning for non-target species: The product has been formulated for use in horses only. Cats, Dogs, especially Collies, Old English Sheepdogs and related breeds or crosses, and also turtles and tortoises may be adversely affected by the concentration of ivermectin in this product if they are allowed to ingest spilled paste or have access to used syringes.

Do not use in mares producing milk for human consumption.Studies performed in laboratory animals showed no teratogenic or embryotoxic affect of ivermectin at the recommended doses during therapy. The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only according to risk/benefit analysis by the responsible veterinary surgeon. Some horses carrying heavy infection of Onchocerca microfilariae have experienced oedema and pruritus following dosing, assumed to be the result of death of large numbers of microfilariae.

These signs resolve within a few days but symptomatic treatment may be advisable.

Ivermectin is extremely dangerous to fish and aquatic life. Treated animals should not have direct access to surface waters and ditches during treatment. Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

includes mydriasis, ataxia, tremors, stupor, coma and death. The less severe signs have been transitory. No antidote has been identified; however, symptomatic therapy may be beneficial.

Withdrawal Periods Meat and offal 34 days.

Not permitted for use in mares producing milk for human consumption.

Operator Warnings Do not eat, drink or smoke while handling the product.

Avoid contact with skin and eyes.

If accidental skin contact occurs, wash the affected area immediately with soap and water.

If accidental eye exposure occurs, flush the eyes immediately with water and, if necessary, get medical attention. Wash hands after use.

Extremely dangerous to fish and aquatic life. Do not contaminate surface waters or ditches with product or used containers.

Any unused product or waste material should be disposed of in accordance with national requirements.

Pharmaceutical Precautions Following intensive exposure to sunlight photolytic degradation of ivermectin may occur.

This is a single dose product.

Discard after use.

Keep out of reach and sight of children.

Legal Category LM Package Quantities High density polyethylene pre-filled dose-graduated disposable syringe containing 6.42 g of product.

VPA 10960/48/1

Overdose Mild transitory signs (slowed pupillary light response and depression) have been seen at a dose of 1.8mg/kg (9 times the recommended dose level). Other signs seen at higher doses

www.bimeda.ie 27

PRODUCT PRODUCT INFORMATION

BIMECTIN POUR-ON Ivermectin 5mg/ml INDICATIONS Licenced for Cattle: For the treatment of infections with - gastro-intestinal worms • Lungworms • Warbles • Mange mites • Sucking and biting lice

BENEFITS • Delivers effective control against a wide range of external and internal parasites • Penetrates quickly to reach and kill parasites • Allows for ease of application and reduced stress to animals and user • Well tolerated by breeding animals

PACKAGING

Bimeda®® Bimeda Broomhill Broomhill Road Road Tallaght Tallaght Dublin 24, Ireland Dublin 24, Ireland Tel: 1850-515253 Fax: 01 451 5803 Tel: 1850-515253 28

LIST NO.

UNIT PACKAGE

1BIM123

2.5L

See reverse side for Administration and Dosage.

www.bimeda.ie www.bimeda.ie

TECHNICAL TECHNICAL INFORMATION INFORMATION

BIMECTIN POUR-ON For Cattle Ivermectin 5mg/ml

PRESENTATION A clear colourless solution containing 5mg Ivermectin and 10mg Benzyl Alcohol per ml.

TARGET SPECIES Cattle.

INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In cattle: For the treatment of infections with the following parasites Gastro-intestinal worms Haemonchus placei (adult and fourth stage larvae) Ostertagia ostertagi (adult and fourth stage larvae, including inhibited larvae) Trichostrongylus axei (adult and fourth stage larvae) Trichostrongylus colubriformis (adult and fourth stage larvae) Cooperia punctata (adult only) Cooperia oncophora (adult only) Strongyloides papillosus (adult only) Oesophagostomum radiatum (adult and fourth stage larvae) Lungworm (adult and fourth stage larvae) – Dictyocaulus viviparus.

Warbles (parasitic stages) – Hypoderma bovis, Hypoderma lineatum.

dogs, especially Collies, old English Sheepdogs and related breeds or crosses, and also in turtles/tortoises.

Do not allow these species to come in contact with this product It is recommended to treat all animals within a herd or group.

The shedding of nematode eggs can continue for some time after treatment.

Frequent and repeated use may lead to the development of resistance. It is important that the correct dose is given in order to minimise the risk of resistance. To avoid under dosing animals should be grouped according to their body weight and dosed according to the heaviest animal in the group.

Close container after use.

in either direction to position the dose indicator to the appropriate dose.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS May be irritating to human skin and eyes and the user should be careful not to apply it to himself or other persons.

Operators should wear rubber gloves, boots, goggles and a waterproof coat when applying the product. Protective clothing should be washed after use.

As absorption through skin can occur, in the event of accidental skin contact, wash the affected area immediately with soap and water.

WITHDRAWAL PERIOD(S) Meat and offal: 31 days.

Milk: Not permitted for use in lactating cattle producing milk for human consumption. Do not use in non-lactating dairy cows, including pregnant dairy heifers, within 60 days of calving.

immediately with water and get medical attention.

Do not smoke, eat or drink while handling the product.

Wash hands after use.

Use only in well ventilated areas or outdoors.

Mange mites – Sarcoptes scabiei var. bovis. The product may also be used to reduce infection of the mange mite Chorioptes bovis, but complete elimination may not occur.

ADVERSE REACTIONS SERIOUSNESS) None known.

Sucking and biting lice – Linognathus vituli, Haematopinus eurysternus, Bovicola (Damalinia) bovis.

Bimectin Cattle Pour-On has persistent activity against infections acquired with Trichostrongylus axei and Cooperia spp. up to 14 days after treatment, but only in the case of group treatment; Ostertagia ostertagi and Oesophagostomum radiatum up to 21 days after treatment; Dictyocaulus viviparus up to 28 days after

USE DURING PREGNANCY AND LACTATION OR LAY Studies in laboratory animals have shown neither embryotoxic nor teratogenic effects with ivermectin.

Can be used during pregnancy and lactation provided that the milk is not intended for human consumption.

(Haematobia irritans) for up to 28 days after treatment; to 35 days post application.

CONTRAINDICATIONS Do not use in cases of known hypersensitivity to the active ingredient.

SPECIAL WARNINGS FOR TARGET SPECIES Do not treat cattle when their hide is wet.

Do not treat cattle if rain is expected, as rain within 2 hours Do not apply to areas of skin which have mange scabs or other lesions, or to areas contaminated with mud or manure.

To avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or in the spine, it is recommended to administer the product at the end of sites.

SPECIAL PRECAUTIONS FOR USE The product has been formulated for topical application other species as severe adverse reactions may occur.

Cases of intolerance with fatal outcome are reported in

(FREQUENCY

AND

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Do not combine ivermectin treatment with vaccination against lungworms. If vaccinated animals are to be treated, treatment should not be carried out within a period of 28 days before or after vaccination.

AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE Assess bodyweight as accurately as possible before calculating the dosage.

Dosage 1ml per 10kg body weight (based on a recommended dosage level of 500 micrograms per kg body weight).

Administration For topical application.

The formulation should be applied along the mid-line of the back in a narrow strip between the withers and tailhead.

The 250 ml and 1.0 litre packs must be used with appropriate dosing equipment.

Instructions for using the dispensing chamber: a) Take dip tube and insert end into base of measuring cap with slotted end going to the bottom of the container. b) Remove shipping cap from container. c) Screw measuring cap onto container. d) Select the correct dose rate by rotating the adjuster cap

excess will return to the bottle) and then tip and apply to animal along backline.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES), IF NECESSARY No signs of toxicity appeared in trials up to 3 times the recommended dose rate.

Clinical symptoms of ivermectin toxicity include ataxia and depression. symptomatic treatment should be given.

INCOMPATIBILITIES None known.

SHELF LIFE Shelf-life of the veterinary medicinal product as packaged for sale: 3 years 6 months.

SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Protect from direct light.

Store in a tightly closed, original container.

If stored at temperatures below 0°C, the solution may appear cloudy. Allowing to warm at room temperature SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIAL, IF ANY life. Do not contaminate surface water or ditches with product or the used container. Any unused product or waste material should be disposed of in accordance with national requirements.

MARKETING AUTHORISATION HOLDER ECO Animal Health Ltd. 78 Coombe Road, New Malden Surrey KT3 4QS UNITED KINGDOM MARKETING AUTHORISATION NUMBER VPA 10831/003/001 LEGAL CATEGORY POM

PACKAGE QUANTITIES 2.5 litre

A full product SPC is available on request from Bimeda or alternatively can be found on the IMB website

www.bimeda.ie www.bimeda.ie

29

PRODUCT INFORMATION PRODUCT PRODUCTINFORMATION INFORMATION

BIMECTIN PLUS BIMECTIN PLUS Ivermectin 10mg/ml Ivermectin 10mg/ml Clorsulon 100mg/ml Clorsulon 100mg/ml

INDICATIONS INDICATIONS INDICATIONS

Licenced for wide range of internal and external parasites Licenced of Licencedfor forwide wide range range of internal internal and and external external parasites parasites Important parasites Include; Important parasites parasites Include; Include; • Important Liver fluke (adult)Fasciola hepatica • Liver fluke (adult)Fasciola hepatica Liver fluke (adult)Fasciola hepatica • • Ostertagia ostertagi (including inhibited larval stages) • Ostertagia ostertagi (including inhibited larval stages) Ostertagia ostertagi (including inhibited larval stages) •• Haemonchus placei • Haemonchus placei Haemonchus placei •• Trichostrongylus axei • Trichostrongylus axei Trichostrongylus axei Cooperia oncophora •••Cooperia oncophora Cooperia oncophora •• •Bunostomum Bunostomum phlebotomum phlebotomum Bunostomum phlebotomum Oesophagostamum radiatum •••Oesophagostamum radiatum • Oesophagostamum • Lungworms (adult and fourth-stage larvae) • Lungworms (adult andradiatum fourth-stage larvae) Lungworms (adult and fourth-stage larvae) Warbles (parasitic stages) •• • Warbles (parasitic stages) Warbles (parasitic stages) Mange mites (Psoroptes bovis, •• • Mange mites (Psoroptes bovis, Mange mites (Psoroptes bovis, • Sarcoptes scabiei var. bovis) Sarcoptes scabiei var. bovis) Sarcoptes scabiei var. bovis) Sucking lice (Linognathus vituli, •• Sucking lice (Linognathus vituli, Sucking lice (Linognathus vituli, • Haematopinus eurystemus, Solenopotes capillatus) Haematopinus eurystemus, Solenopotes capillatus) Haematopinus eurystemus, Solenopotes capillatus) The product may also be be used used as as an an aid aid in in the the control controlof of biting lice (Damalinia andas the mitecontrol Chorioptes The product may alsobovis) be used anmange aid in the of biting lice (Damalinia bovis) and the mange mite Chorioptes bovis, but complete elimination elimination may may not not occur. occur. biting lice (Damalinia bovis) and the mange mite Chorioptes bovis, but complete elimination may not occur.

BENEFITS BENEFITS BENEFITS

• Broad Broad spectrum spectrumtreatment treatmentand andcontrol controlofofinternal internaland and Broad spectrum treatment parasites inincattle • external external parasites cattle and control of internal and external parasites in cattlefluke, worms and lice in 1 •• 3-in-1 solution for chronic fluke, worms and lice in 1 3-in-1 solution for chronic • injection injection 3-in-1 solution for chronic fluke, worms and lice in 1 • Contains Contains powerfulingredients ingredientsIvermectin Ivermectinand and injection 22powerful • Clorsulon Clorsulon Contains 2 powerful ingredients Ivermectin and •• Improved Improved animalperformance performance Clorsulonanimal ••• Cost Cost effective parasitic controlininyour yourherd herd Improved animal performance effective parasitic control • Cost effective parasitic control in your herd

PACKAGING PACKAGING LIST NO. LIST NO. 1BIM162

UNIT PACKAGE UNIT50ml PACKAGE

1BIM130

500ml

1BIM162 1BIM129 1BIM129 1BIM130

50ml 250ml 250ml 500ml

See reverse side for Administration and Dosage.

Bimeda® Bimeda® ® Broomhill Bimeda Road Broomhill Tallaght BroomhillRoad Road Dublin 24, Ireland Tallaght Tallaght Tel: 1850-515253 Dublin 24,Ireland Ireland Fax: 01 451 5803 Dublin 24, Tel: 1850-515253 Fax: 01 451 5803 Tel: 1850-515253 30

See reverse side for Administration and Dosage.

www.bimeda.ie www.bimeda.ie www.bimeda.ie

TECHNICAL TECHNICAL INFORMATION INFORMATION

BIMECTIN PLUS Solution for Injection Ivermectin 10mg/ml, Clorsulon 100mg/ml PRESENTATION A clear colourless to pale yellow sterile non-aqueous solution containing Ivermectin (10mg/ml) and Clorsulon(100mg/ml) TARGET SPECIES Cattle.

INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For the effective treatment and control of the following harmful parasites of cattle, sheep and pigs: Cattle Bimectin Plus is indicated for the treatment of mixed trematode and nematode or arthropod infestations of the following parasites: Gastrointestinal roundworms (adult and fourth-stage larvae): Ostertagia ostertagi (including inhibited larval stages) O. lyrata Haemonchus placei Trichostrongylus axei T. colubriformis Cooperia oncophora C. punctata C. pectinata Bunostomum phlebotomum Oesophagostamum radiatum Strongyloides papillosus (adult) N. spathiger (adult) N. helvetianus (adult) Trichuris spp (adult) Lungworms (adult and fourth-stage larvae) Dictyocaulus viviparous (adult): Fasciola hepatica Eye worms (adult): Thelazia spp Warbles (parasitic stages): Hypoderma bovis H. lineatum Mange mites: Psoroptes bovis Sarcoptes scabiei var. bovis Sucking lice: Linognathus vituli Haematopinus eurysternus Solenopotes capillatus.

Bimectin Plus may also be used as an aid in the treatment of biting lice (Damalinia bovis) and the mange mite Chorioptes bovis, but complete elimination may not occur.

Persistent activity Bimectin Plus given at the recommended dosage of 0.2mg/kg bodyweight controls re-infection with Haemonchus placei, Cooperia spp. and Trichostrongylus axei acquired up to 14 days after treatment, Ostertagia ostertagi and Oesophagostomum radiatum acquired up to 21 days after treatment and Dictyocaulus viviparus acquired up to 28 days after treatment.

CONTRAINDICATIONS This product is not to be used intramuscularly or intravenously.

Bimectin Plus Injection is a low volume product authorised for use in cattle. It must not be used in other species as severe adverse reactions, including fatalities in dogs, may occur.

SPECIAL WARNINGS FOR TARGET SPECIES Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy: 路 Too frequent and repeated use of anthelmintics from the same class, over an extended period of time. 路 Underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dosing device (if any).

Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

SPECIAL PRECAUTIONS FOR USE i) Special precautions for use in animals This product does not contain any antimicrobial preservative. Swab septum before removing each dose. ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals Do not smoke or eat whilst handling the product.

Wash hands after use. Take care to avoid self-injection: the product may cause local irritation and/or pain at the injection site. iii) Other precautions Treated cattle should not have direct access to ponds, streams or ditches for 14 days after treatment.

ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) Transitory discomfort has been observed in some cattle following subcutaneous administration. A low incidence of soft tissue swelling at the injection site has been observed. These reactions disappeared without treatment..

USE DURING PREGNANCY AND LACTATION OR LAY Can be used in pregnancy and lactation.

Can be used in breeding animals. : Please refer to withdrawal periods INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known.

AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE Dosage and duration of treatment A single dose of 1ml per 50kg bodyweight, i.e. 200渭g ivermectin and 2mg clorsulon per kg bodyweight.

Method of administration Bimectin Plus should be administered only by subcutaneous injection under the loose skin in front of or behind the shoulder.

Divide doses in excess of 10 ml between different injection sites and use different sites to those used for other parenteral medications.

A sterile 17 gauge 陆 inch (15-20mm) needle is recommended.

When using the 500ml pack size use only automatic syringe equipment. For the50ml pack size, use of a multidose syringe is recommended.

The timing of treatment should be based on epidemiological factors and should be customised for each individual farm. A dosing program should be established by a professional person.

To ensure a correct dosage, body weight should be determined as accurately as possible; accuracy of the dosing device should be checked.

If animals are to be treated collectively rather than individually, to avoid under- or over-dosing, they should be grouped according to their bodyweight and dosed accordingly.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES), IF NECESSARY A dose of 25ml product per 50kg bodyweight (25 times the recommended dose level) may result in an injection site lesion, including tissue necrosis, oedema, and No other drug-related reactions have been observed.

WITHDRAWAL PERIOD(S) Cattle Meat and Offal: 66 days Milk: Do not use in cattle producing milk for human consumption. Do not use in non-lactating dairy cows including pregnant heifers within 60 days of calving.

INCOMPATIBILITIES Do not mix with other medicinal products.

SHELF LIFE Shelf-life of the veterinary medicinal product as packaged for sale: 3 years Shelf-life after opening the immediate packaging: Following withdrawal of the dose, use the product within 28 days. Discard unused material.

SPECIAL PRECAUTIONS FOR STORAGE Protect from light.

Keep the container in the outer carton in order to protect from light.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIAL, IF ANY EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with the product or used container. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

MARKETING AUTHORISATION HOLDER Bimeda Chemicals Ltd., Broomhill Road, Tallaght, Dublin 24. Ireland.

MARKETING AUTHORISATION NUMBER VPA 10960/070/001 LEGAL CATEGORY POM

PACKAGE QUANTITIES 50ml, 250ml and 500ml

A full product SPC is available on request from Bimeda or alternatively can be found on the IMB website

www.bimeda.ie www.bimeda.ie

31

PRODUCT PRODUCT INFORMATION

BIOCOLOST B Colostrum INDICATIONS For the provision of colostral antibodies for rapid enhancement of immunity in newborn calves and lambs.

BENEFITS • Concentrated immunoglobulin colostrum feed for the new born calves and lambs • Ready to use bottle • Does not require heating or refridgeration • Sourced from first milking of third lactation cows from veterinary certified clear herds • RTU formulation

PACKAGING LIST NO.

UNIT PACKAGE

CASE SIZE

1BIO001

100 ml

24

See reverse side for Administration and Dosage.

Bimeda®® Bimeda Broomhill Broomhill Road Road Tallaght Tallaght Dublin 24, Ireland Dublin 24, Ireland Tel: 1850-515253 Fax: 01 451 5803 Tel: 1850-515253 32

www.bimeda.ie www.bimeda.ie

TECHNICAL INFORMATION

BIOCOLOST B

Colostrum

PURPOSE Provision of colostral antibodies for rapid enhancement of resistance in newborn calves and lambs.

COMPOSITION Whey from colostrum, lactose CONTENTS Crude protein 13.0 %; Crude ash 1.5 %; Crude fat 0.5 %; Crude fibre 0.0 %; Water 85 %.

FEEDING INSTRUCTIONS Lamb: 5-10ml (10ml dosing pipette available on request) Calf: 1 bottle (100ml) to be given orally, immediately after birth, or within the first 6 hours of life. At the first signs of diarrhoea, divide the application in two parts over two feedings.

SHELF LIFE AND STORAGE INSTRUCTIONS Shelf life: 24 months Storage at temperatures between 4째C and 20째C PACK SIZE 100 ml bottle in cardboard box

www.bimeda.ie 33

PRODUCT INFORMATION

BOVISAL PEARLS INDICATIONS Liquid Calcium Gel with sustained release Pearls for compensation of deficient situations in cows, after calving.

BENEFITS • Contains 56g organic calcium • 4 different calcium sources • Sustained release component (Ca pearls) • Contains phosphorus • 2 applications only • Excellent palatability • Rapid absorption of the calcium gel • Excellent bioavalability • Glucoplastic energy • Free of calcium chloride

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

1BOV022

500ML

12

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 34

www.bimeda.ie

TECHNICAL INFORMATION

BOVISAL PEARLS

56g of calcium 11g of phosphorus 600mg magnesium 2.5MJ glucoplastic energy Feeding instructions Shake bottle well before use Direct oral application One bottle immediately after calving One bottle 12hrs after calving Composition Calcium prioponate Calcium phosphate Calcium formate Calcium acetate Magnesium chloride Sodium phosphate Ingredients in weight/volume Crude protein 0% Crude Fat 0% Crude fibre 0% Crude Ash 24% Calcium 9.3% Phosp 1.8% Magnesium 0.1% Water 59%

Shelf life= 12 months Pack size 12 X 500ml bottles

stabilised calcium metabolism

2nd a hours pplicatio n (1 after calvin 2 g)

One 600g bottle contains-

Energy Supply Propionate, Acetate, Formate, Organic Acids Total energy supply per 500ml container 2.5MJ glucoplastic energy 2.5MJ =597 kCal

1st a p (afte plicatio n r calv ing)

Feed supplement for cows

rapid relase calcium slow relase calcium total calcium

www.bimeda.ie 35

PRODUCT INFORMATION

BOVISEAL

Bismuth Subnitrate 2.6g INDICATIONS • Boviseal is suitable to use with any antibiotic dry cow treatment • Reduces new intramammary infections in the dry period • Reduces clinical mastitis in subsequent lactation

BENEFITS • Seals the teat from the moment of drying off until calving • Protection for the entire dry cow period thus reducing cases of dry cow mastitis • Less cases of mastitis in the next lactation • Proven efficacy in mastitis prevention through trial work and customer satisfaction • Nil milk withdrawal when used on it’s own • Can be combined with any other dry cow tube for a synergistic approach to mastitis prevention and control

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

1BOV010

120 SYRINGES

1

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 36

www.bimeda.ie

TECHNICAL INFORMATION

BOVISEAL NA

Bismuth Subnitrate 2.6g Presentation Boviseal is an off-white smooth paste. It is presented in syringes each containing 4g intramammary infusion containing 65% Bismuth Subnitrate, in a mineral oil vehicle.

Uses Boviseal is indicated for the prevention of new intramammary infections throughout the dry period.

This results in a reduction in the incidence of sub clinical mastitis in cows at calving, and of clinical mastitis in the dry period and the subsequent lactation (for at least 60 days after calving).

It is recommended that Boviseal be used as part of a herd approach to dry cow management and mastitis control. Cows considered likely to be free of sub clinical mastitis should be given Boviseal at drying off according to the criteria below.

Other animals should be managed in accordance with an approved mastitis control plan or specific veterinary advice.

For practical purposes, selection criteria may be based on the mastitis and cell count history of individual cows, or recognised tests for the detection of sub clinical mastitis or bacteriological sampling.

It is particularly important that, prior to treatment, an individual cell count be obtained from any cow with a history of clinical mastitis during the previous lactation. As a guide, cows with an average cell count less than 200,000 cells/ml before drying off may be given Boviseal. A minor increase (cell count up to 250,000 cells/ml) during the last 4 weeks before drying off is normal and

may be ignored. In case of doubt, veterinary advice should be sought Dosage and Administration Dosage One syringe into each udder quarter immediately after the last milking of the lactation (at drying off).

Administration At drying off the teat should be thoroughly cleaned and disinfected, and it should be allowed to dry before infusion; this is essential, as Boviseal possesses no antimicrobial activity.

Care should also be taken to avoid contamination of the syringe nozzle.

Insert nozzle into the teat and apply gentle and continuous pressure until the paste is expressed. Do not massage the teat or udder after infusion of the product. It is advisable to use an appropriate teat disinfectant following the infusion.

Contra-indications, Warnings, etc.

Not intended for use in cows with a suspected or confirmed intramammary infection at drying off.

Pharmaceutical Precautions Keep out of the reach and sight of children. For animal treatment only.

Legal Category

LM

Package Quantities 120 syringes.

Further Information Most of the seal comes out at the first stripping, suckling or milking after calving, but small amounts may occasionally be seen for a few days as flecks on the filter. Boviseal can be differentiated from mastitis by its texture. Under cold conditions the product may be warmed to room temperature in a warm environment, to aid syringeability. Individual tubes must not be placed in warm water.

Any unused product or waste material should be disposed of in accordance with national requirements.

Operator Warnings No special precautions.

VPA No. 10960/49/1

Do not use in the lactating cow.

If lactating cows are accidentally infused the seal can easily be stripped out manually and no additional precautions are needed.

If a sealed quarter develops clinical mastitis the affected quarter should be stripped out manually before appropriate antibacterial therapy is instituted. For single use only.

Withdrawal Periods Meat and offal: zero days Milk: zero days

www.bimeda.ie 37

PRODUCT INFORMATION

BOVIMAST DC Cloxacillin 500mg INDICATIONS • For Routine use in Dairy Cows at drying off to treat existing intramammary infections and to assist in the prevention of new infections occurring during the dry period. Cloxacillin has activity against following sensitive pathogens associated with mastitis • Staphylococci spp • Micrococci • Streptococcus agalactiae • Corynebacterium spp

BENEFITS • Proven Cloxacillin formulation • Powerful against Staph aureus, thus reducing SCC’s • Eliminates drying off infection and helps to prevent further infection picked up during the dry period • Can be used successfully with Boviseal • Short withdrawals 28 days +120 hours

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

1BOV011

120 SYRINGES

1

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 38

www.bimeda.ie

TECHNICAL INFORMATION

BOVIMAST DC Cloxacillin 500mg Presentation A plastic syringe containing 3 g of a sterile off-white oily intramammary suspension intended for intramammary administration to animals. Each 3 g syringe contains 500 mg Cloxacillin (as Cloxacillin Benzathine).

Uses For routine use in cows at drying off, to treat existing intramammary infections and to assist in preventing new infections occurring in the dry period. Bovimast DC contains Cloxacillin which is active against the following major pathogens associated with mastitis; Penicillin resistant and sensitive Staphylococcus spp., Micrococcus spp., Streptococcus agalactiae, Corynebacterium spp.

Dosage and Administration For intramammary administration only. The contents of one syringe should be infused into each quarter via the teat canal immediately after the final milking in a lactation. Before infusion, the teat should be thoroughly cleaned and disinfected and care should be taken to avoid contamination of the injector nozzle.

Contra-indications, Warnings etc.

Do not use in lactating cows.

Do not use within 28 days of calving.

Withdrawal Periods Animals intended for human consumption should not be slaughtered until 28 days after the last treatment. Milk for human consumption may only be taken from 120 hours after calving in a cow with a dry period of more than 28 days. Milk for human consumption may only be taken from 28 days plus 120 hours after the last treatment in cows with a dry period of 28 days or less.

Operator Warnings Penicillin and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact.

Hypersensitivity to penicillin may lead to cross sensitivity to cephalosporins and vice versa.

Allergic reactions to these substances may occasionally be serious.

doctor this warning. Swelling of the face, lips and eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.

Pharmaceutical Precautions Do not store above 25째C. Keep out of reach and sight of children. For animal treatment only.

Package Quantities 120 syringes.

Legal Category:

POM

VPA Number: 10960/53/1

1. Do not handle this product if you know you are sensitized or if you have been advised not to work with such preparations.

2. Handle this product with great care to avoid exposure, taking all recommended precautions.

3. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the

www.bimeda.ie 39

PRODUCT PRODUCT INFORMATION

BOVIFERM PLUS ®

INDICATIONS Supplementary feeding stuff for the diarrheoic calf.

Boviferm solution is suitable to be fed with milk. For rapid rehydration and acidosis correction.

BENEFITS • Highest rehyration properties and Strong Ion Difference (SID) • Can be mixed with milk • Calf can remain on milk feed • Very palatable • Contains Oralin, a microbial additive that stabilises the gut flora

PACKAGING

Bimeda®® Bimeda Broomhill Broomhill Road Road Tallaght Tallaght Dublin 24, Ireland Dublin 24, Ireland Tel: 1850-515253 Fax: 01 451 5803 Tel: 1850-515253 40

LIST NO.

UNIT PACKAGE

CASE SIZE

1BOV021

115G SACHET

12

See reverse side for Administration and Dosage.

www.bimeda.ie www.bimeda.ie

TECHNICAL TECHNICAL INFORMATION INFORMATION

BOVIFERM® PLUSSID • Supplementary feed for calves with diarrhoea • For the stabilisation of water and electrolyte balance • Compatible with milk digestion Boviferm® plusSID provides the calf with electrolytes, buffering agents, energy, lactic acid bacteria, mucins and bulking agents as well as toxin binding substances, for rehydration.

COMPOSITION Dextrose; Whey powder; Sodium propionate, Sodium chloride; Potassium chloride; Banana flakes; Pre-gelatinised rice flour; Calcium chloride; Magnesium chloride.

CONTENTS Crude protein 4.0%; Crude fibre 1.4%; Crude fat 0.5%; Crude ash 21.0%; Sodium 4.4%; Potassium 1.7%; Chlorides 3.8%; moisture 6.0%.

ADDITIVES PER KG. Bentonite Montmorillonite; Guar seed flour; Citrus pectin; Camomile; Aniseed; Fennel seed; Enterococcus faecium DSM 10663 NCIMB 10415 (E 1707) (ORALIN®) 1.75 x 1010 CFU

FEEDING INSTRUCTIONS In case of risk of, during periods of, or recovery from digestive disturbance (diarrhoea): Twice per day: Give 1 sachet (115 gm) of Boviferm® plusSID mixed into 2 litres of water and add 0.5 to 4 litres of milk or milk replacer (according to the calf’s daily requirement).

Administer Boviferm® plusSID until diarrhoea stops, at minimum for 2 to 3 days. Do not stop milk feeding. Additionally give water ad libitum.

It is recommended that a veterinarian’s opinion be sought before use.

SPECIAL INSTRUCTIONS As Boviferm® plusSID contains viable lactic acid bacteria, the mixing temperature should not exceed 50°C. STABILITY 18 months

STORAGE Cool and dry

PACK SIZE Box of 24 x 115 g

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41

PRODUCT PRODUCT INFORMATION

CALCIUM BOVISAL INDICATIONS Liquid mineral feed supplement, for the prevention and compensation of calcium deficiency in cows before and after calving.

BENEFITS • • • • •

Calcium plus energy in one product Excellent palatability Reduces the risk of parturient paresis Easy to administer Can be used in conjunction with calcium injection

PACKAGING

Bimeda®® Bimeda Broomhill Broomhill Road Road Tallaght Tallaght Dublin 24, Ireland Dublin 24, Ireland Tel: 1850-515253 Fax: 01 451 5803 Tel: 1850-515253 42

LIST NO.

UNIT PACKAGE

CASE SIZE

1BOV022

500ml

12

See reverse side for Administration and Dosage.

www.bimeda.ie www.bimeda.ie

TECHNICAL TECHNICAL INFORMATION INFORMATION

CALCIUM BOVISAL Liquid mineral feed supplement, for the prevention and compensation of calcium deficiency in cows before and after calving.

FEEDING INSTRUCTIONS 4 bottles to prevent hypocalcaemia (calcium deficiency): 1st bottle approx. 12 hours before calving 2nd bottle immediately after calving 3rd bottle 8 -12 hours after calving 4th bottle 20 - 24 hours after calving.

2 bottles following calcium infusion: to prevent recurrence (relapses) 1 bottle immediately after the infusion 1 bottle 8 -12 hours after the infusion (If necessary, a third bottle may be administered after a further 8 - 12 hours).

COMPOSITION Minerals.

INGREDIENTS IN WEIGHT/VOLUME Crude protein 0.10%; Crude fat 0.00%; Crude Ash 12.30%; Crude fibre 0.0%; Calcium 10.00%; Magnesium 0.14%; Phosphorus 0.00%; Sodium 0.00%; Water 71.00%.

ADDITIVES PER KG. Calcium propionate; Formic Acid; Propionic Acid.

ENERGY SUPPLY Sources of glucoplastic energy: Propionate, Acetate, Organic Acids Total supply of glucoplastic energy per 500 ml: 3.1 MJ (=740 Kcal).

SHELF LIFE 24 months PACK SIZE 12 x 500 ml bottles (PET)

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43

PRODUCT INFORMATION

CONVITAL EQUILYTES Potassium ions Magnesium ions Calcium ions INDICATIONS • Pottasium, Magnesium and Calcium Ion Oral Electrolyte Paste in an amino acid chelate form for the Hard Working Horse

BENEFITS • Electrolyte paste for horses • Fast acting, highly absorbant and bioavailable in minutes • Palatable due to molasses base • Special formulation containing potassium, magnesium and calcium ions in an amino acid chelate form • 3 x 60g presentation ideal for the hard working horse

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

1EQU001

60G

12

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 44

www.bimeda.ie

TECHNICAL INFORMATION

CONVITAL EQUILYTES Potassium ions Magnesium ions Calcium ions ALL NATURAL WITH AMINO ACIDS

Electrolytes are muscle impulse conductors. The electrolytes calcium, potassium and magnesium (Ca++, K+ and Mg++) are necessary for the proper function of muscle, both cardiac and skeletal in the horse.

WHAT HAPPENS WHEN A HORSE WORKS HARD?

During the stringent, prolonged exercise and sweating, that a horse undergoes while racing, large quantities of these ions are lost, resulting in fatigue and exhaustion. During maximum physical stress, your horse can sweat away about 32 pounds of body fluids. He’s not just losing water, he’s losing the electrolytes essential to smooth, efficient muscle function. Each muscle used by the horse produces heat and releases potassium into the blood, causing veins and arteries to expand and increase in size to the maximum carrying capacity.

The added circulation carries away heat from the muscle to cool them. As water is drawn out of the muscle cells to produce sweat, the cells operate with decreasing efficiency. The horse becomes weak and exhausted from the loss of potassium. The magnesium lost can result in both fatigue and muscle cramps. Calcium is also excreted in the horse’s sweat and this loss can cause a metabolic imbalance know as the “thumps” where the diaphragm spasmodically contracts, synchronised with the heartbeat.

HOW CAN EXHAUSTION BE PREVENTED?

To prevent dehydration, exhaustion and metabolic disorders your horse needs water and electrolytes during and after physical stress, and he needs them in the body tissue where they can act to keep his muscles performing at their peak. Your

horse also needs glucose, which is the only carbohydrate that is used for energy, and is a by-product of fructose and gluctose metabolism.

Glucose is stored by the horse in the form of muscle glycogen, which is depleted as it is used for “fuel” by the working muscles.

HOW DO THE SUPPLEMENTS WORK?

Attempts to replace these ions by feeding the usual electrolyte salts produce unpredictable results.

The chloride salts of potassium, magnesium and calcium when given to the horse in either food or water may not be absorbed into the blood for numerous reasons, including · Competition between ions for transporting proteins to be carried into intestinal cells. Some competing ions can be antagonistic and prevent absorption. · Concentration of each ion. · Solubility of the ions associated molecules.

Because of these, and other variables in electrolyte absorption from the gut, the replacement of the lost electrolytes by use of the old “salt “ forms in the water make absorption and cellular balancing erratic unpredictable, and therefore unreliable. The athletic horse, especially during an event or competition needs to have lost electrolytes replaced rapidly and in a predictable manner.

WHY IS CONVITAL EQUILYTES DIFFERENT?

Convital Equilytes contains potassium magnesium and calcium ions concentrated in an amino acid “chelate” form to make them highly absorbable and rapidly bioavailable. As a stable amino acid-electrolyte chelate, Equilytes is not ionized in the gut, but absorbed intact through a different pathway.

This means that the electrolytes are transported across the gut wall to the blood where they become

bioavailable in minutes rather than hours. Equilytes provides your horse with fructose as an energy source. The amino acid L-glutamine is also contained in Equilytes as a direct and immediate energy source, since it can be used in addition to glucose as a fuel by the brain cells in their very active metabolism. Glutamine passes readily through the blood brain barrier, and is transformed into glutamic acid which is then used as fuel.

HAS CONVITAL EQUILYTES BEEN TESTED?

In order to obtain clinical date for the use of Electrolytes chelated to amino acids (“convital equilytes”) a controlled study was made of the “Horsetooth Mountain Endurance Ride” held in June 1987, near Fort Collins, Colorado under the control of K.A. Larson, DVM Ph.D. This study has shown “test” horses treated with Equilytes maintained significantly higher levels of Ca++, Mg++ and K+ during race when compared with untreated controls, demonstrating the rapid uptake and bioavailability in the product.

INGREDIENTS:

Sodium chloride, potassium chloride, chelated calcium, chelated magnesium, Fructose, L-glutamine, and benzoic acid. Calcium and magnesium are chelated to amino acids.

Molasses base.

DOSAGE:

Apply paste directly from syringe to back to tongue. For horses undergoing stress, administer per 1,000 pounds (454kg) of bodyweight, or one-half syringe one hour prior to and one-half syringe immediately following event of workout. Water horse after administering.

www.bimeda.ie 45

PRODUCT INFORMATION

CONVITAL R 7 Vitamins 11 Minerals INDICATIONS • A Multivitamin, Mineral and Trace Element Feed Supplement tailored to the Performance Horse, • Designed for Dosing or in feed application

BENEFITS • A highly palatable syrup based racing formula containing multi vitamin, mineral and trace elements • Leaves a shine on coat of animals • Excellent hoof care • Can be administered in feed • Consistent results for racing & performance animals • Durable easy handle pack

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

1CON007

4.5L

4

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 46

www.bimeda.ie

TECHNICAL INFORMATION

CONVITAL-R Presentation Vitamin & Mineral Supplement For Horses In Training.

Contains vitamin A palmitate, irradiated dried yeast, brewer’s dried yeast, yeast extract, thiamine hydrochloride, riboflavin, pyridoxine hydrochloride, niacin, vitamin E supplement, cane molasses, barley malt, water, glycerine, tragacanth, tribasic calcium phosphate, manganese phosphate, magnesium phosphate, copper phosphate, zinc oxide, potassium iodide, cobalt sulphate; preserved with phosphoric acid and sodium benzoate.

Suggested daily dose Horse in training 60 ml (including polo ponies, showjumpers, endurance horses).

Ponies 30 ml Each 30 ml contains: VITAMINS Vit. A 20,000 i.u.

Vit. B1 (Thiamine) 12 mg Vit. B2 (Riboflavine) 20 mg Vit. B6 (Pyridoxine) 6 mg Niacin 60 mg Vit. D3 3,000 i.u.

Vit. E 40 mg

MINERALS Calcium 1,700 mg Phosphorus 1,314 mg Potassium 486 mg Sodium 460 mg Iron 34 mg Manganesse 6.3 mg Magnesium 71.5 mg Copper 4.6 mg Zinc 4.6 mg Iodine 0.54 mg Cobalt 0.72 mg This product should be supplemented with Sodium Chloride (salt lick) to meet the needs of the animals. As a nutritional diet supplement CONVITAL-R Syrup is best administered mixed with the feed.

Convital Syrup contains: Total Carbohydrate 17.45% Protein 1.21% Ash 18.33% Water 50.63% STIR WELL KEEP IN A COOL PLACE 4.54 Liter, 1 Gallon 1.20 U.S Gallons

(CONVITAL-R Syrup contains other natural B complex factors from yeast and yeast extracts).

www.bimeda.ie 47

PRODUCT PRODUCT INFORMATION

CRONYXIN INJECTION Flunixin 50mg/ml INDICATIONS Potent non-steroidal anti-inflammatory drug for use in horses and cattle.

BENEFITS • Quick onset of effective analgesic activity (relief of pain occurs in 15 minutes) • Wide margin of safety, no adverse reactions when used as directed • Potent non-narcotic, non-steroidal antiprostaglandin analgesic • Anti-infammatory and anti-pyretic activity • Better efficacy through widespread distribution in the body • Potent, significantly more pain relief than with pentazocine, meperidine and codeine.

PACKAGING

Bimeda®® Bimeda Broomhill Broomhill Road Road Tallaght Tallaght Dublin 24, Ireland Dublin 24, Ireland Tel: 1850-515253 Fax: 01 451 5803 Tel: 1850-515253 48

LIST NO.

UNIT PACKAGE

CASE SIZE

1CRO002

100 ml

12

1CRO004

50 ml

12

See reverse side for Administration and Dosage.

www.bimeda.ie www.bimeda.ie

TECHNICAL INFORMATION

CRONYXIN INJECTION Flunixin 50mg/ml Presentation Cronyxin Injection is a clear, sterile, aqueous solution for injection.

Each ml contains Flunixin 50mg (as Flunixin Meglumine), Phenol 5mg (preservative), Sodium Formaldehyde Sulfoxylate (antioxidant) and Propylene Glycol (co-solvent).

USES Cattle For the control of acute inflammation associated with respiratory disease. For use as adjunctive therapy in the treatment of acute mastitis.

Horses For the alleviation of inflammation and pain associated with musculoskeletal disorders. For the alleviation of visceral pain associated with colic.

DOSAGE AND ADMINISTRATION Cattle The recommended dose is 2ml Cronyxin injection per 45kg bodyweight (equivalent to 2.2mg flunixin per kg) injected intravenously and repeated as necessary at 24 hour intervals for up to 5 consecutive days.

The cause of the acute inflammatory condition should be determined and treated with concomitant therapy.

Horses For use in equine musculoskeletal disorders, the recommended dose is 1ml Cronyxin Injection per 45kg bodyweight (equivalent to 1.1mg flunixin per kg) injected intravenously and repeated as necessary at 24 hour intervals for up to 5 consecutive days according to response.

For use in equine colic, the recommended dose is 1ml Cronyxin Injection per 45kg bodyweight (equivalent to 1.1mg flunixin per kg) injected intravenously and repeated once or twice if signs of colic recur. The cause of colic should be determined and treated with concomitant therapy.

CONTRAINDICATIONS, WARNINGS ETC. Do not exceed the recommended dose or treat animals for more than 5 consecutive days. Use is contra-indicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastrointestinal ulceration or bleeding, where there is evidence of a blood dyscrasia or hypersensitivity to the product. Avoid intra-arterial injection. Avoid use in dehydrated, hypovolemic or hypotensive animals as there is a potential risk of increased renal toxicity. Not to be used in animals with known hypersensitivity to the active ingredient. For animal treatment only.

UNDESIRABLE EFFECTS (GENERAL) Prolonged use of NSAIDs, including flunixin, may predispose or lead to gastro-intestinal irritation, and in severe cases, ulceration.

SPECIAL PRECAUTIONS FOR USE NSAIDs can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with bacterial infections appropriate concurrent antimicrobial therapy should be instigated. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs to produce an increase in non-bound pharmacologically active concentrations, which can lead to toxic effects.

Use in any animal less than 6 weeks of age or

in aged animals may involve additional risk. If such use cannot be avoided animals may require a reduced dosage and careful clinical management. It is preferable that flunixin is not administered to animals undergoing general anaesthesia until fully recovered. Concurrent administration of potentially nephrotoxic drugs should be avoided..

USE DURING PREGNANCY AND LACTATION Do not administer to pregnant mares. Studies to demonstrate safety in pregnant mares have not been conducted.

DRUG INTERACTIONS Do not mix Cronyxin with other medicaments prior to administration.

Monitor drug compatibility closely where adjunctive therapy is required. Cronyxin may potentiate the effects of warfarin and other such drugs. Do not administer other NSAIDs concurrently or within 24 hours of each other. Due to their common mode of action, flunixin may potentiate and be potentiated by other NSAIDs which act by interfering with prostaglandin synthesis.

WITHDRAWAL PERIOD(S) Milk from lactating cows should be discarded during treatment and may only be taken for human consumption after 36 hours following treatment. Animals may not be slaughtered for human consumption during treatment. Animals may be slaughtered for human consumption only after 7 days from the last treatment. Not for horses intended for human consumption.

PHARMACEUTICAL PRECAUTIONS Keep out of reach and sight of children.

Do not store above 25°C. Following withdrawal of the first dose, use the product within 28 days.

Avoid the introduction of contamination during use. Should any apparent growth or discolouration occur, the product should be discarded.

LEGAL CATEGORY POM PACKAGE QUANTITIES 250ml and 1 litre FUTHER INFORMATION Non-steroidal anti-inflammatory drugs are not permitted substances under the Rules of Racing and under rules covering other competitive events.

Veterinary surgeons administering NSAIDs to racehorses should refer to Section 4.4 of the RCVS Guide to Professional Conduct. Section 4.4.7 states ‘If a veterinarian recommends the discontinuance of any substance…….. not less than eight days before racing (even though such period may be longer than is necessary in many instances) he should be able to feel that he has catered for all but the most exceptional cases’.

VPA 10126/064/001

www.bimeda.ie 49

PRODUCT INFORMATION

CYCLO SPRAY Chlorotetetracycline 200mg/ml INDICATIONS • Target species pigs sheep cattle • Prevention of infections of superficial traumatic or surgical wounds caused by micro-organisms sensitive to chlortetracycline.

• The product can be used as part of a treatment for superficial claw/hoof infections, in particular interdigital dermatitis (foot rot) in sheep and digital dermatitis in cattle.

• Above as SPC sheet

BENEFITS • Registered for use in cattle, sheep and pigs • Nil meat and milk withdrawal • Special nozzle for minimal dispersion, no leak age, or blockage • Contains safe and EU approved patented blue colour agent • No dripping and dries fast • Excellent for foot infection treatments in sheep and cattle

PACKAGING LIST NO.

UNIT PACKAGE

CASE SIZE

1CYC002

211ml

12

See reverse side for full indications, administration and dosage.

Bimeda® Broomhill Road Tallaght Dublin 24, Ireland Tel: 1850-515253 50

www.bimeda.ie

TECHNICAL INFORMATION

CYCLO SPRAY 2.45 % W/W Chlorotetetracycline 200mg/ml Presentation Cutaneous spray containing Chlorotetracycline HCl Target Species Cattle, sheep and pigs.

Uses Treatment of superficial traumatic or surgical wounds contaminated with chlorotetracycline-sensitive agents.

The product can be used as part of a treatment for superficial skin and claw/hoof infections, in particular interdigital dermatitis (foot rot and foul in the foot) and digital dermatitis caused by micro-organisms sensitive tochlorotetracycline.

Suitable for use during pregnancy/ lactation.

Contraindications, warnings etc Do not use in case of hypersensitivity to tetracyclines or to other ingredients of the product.

Do not use on the udder of lactating animals if milk is intended for human consumption.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to chlorotetracycline and may decrease the effectiveness of treatment with other tetracyclines, due to the potential for cross resistance.

Dosage and Administration Protect the eyes when spraying in the vicinity of the head. Clean the affected area thoroughly before spraying. After administration on the claw/hoof the animal should be kept on a dry ground at least for an hours time. Use of the

product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

The container should be held at a distance of approximately 15-20 cm from the area to be sprayed; spray for 3 seconds until the treatment-area is evenly coloured. In case of claw/hoof infections this treatment should be repeated after 30 seconds. For treatment of superficial traumatic or surgical wounds contaminated with chlorotetracycline-sensitive agents a single administration is recommended.For treatment of Dermatitis Digitalis administration twice with a 30 second interval during three consecutive days once or twice daily is recommended.

For treatment of other claw/hoof infections (foot rot and foul in the foot), administration twice with a 30 second interval once or twice daily is recommended. Dependent on the seriousness of the injury and the rate of improvement treatment should be repeated within 1 to 3 days.

Operator Warnings Because of the risk of sensitisation and contact dermatitis, skin contact should be avoided. Wear appropriate impermeable gloves whilst handling the product.Because of risk of eye irritation, contact with the eyes should be avoided. Protect the eyes and face. Do not spray on a naked flame or any incandescent material.

Do not pierce or burn, even after use.

Avoid inhaling vapours. Apply the product in open air or in sufficiently ventilated area.

Wash hands after use.

Do not eat or smoke whilst administering the product.

Withdrawal Period(s) Meat : zero days Milk : zero days Shelf-life Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

Storage Do not store above 25째C. Do not refrigerate or freeze. Protect from frost. Pressurized container. Do not expose the container to direct sunlight or to temperatures higher than 50째. Keep away from sources of ignition.

Disposal Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Package Quantities 211ml bottles LEGAL CATEGORY POM VPA 10989/049/001

www.bimeda.ie 51

PRODUCT INFORMATION

CYCLOSOL LA Oxytetracycline 200mg/ml INDICATIONS • Indicated in Cattle and pigs fot the treatment of infections caused by oxytetracycline sensitive organisms • Cyclosol LA is a Long Acting Injection, one injection giving three days antibiotic cover • If necessary the long acting treatment should be repeated after 72 hours

BENEFITS • Long activity • Tissue friendly • Short withdrawal periods • Cattle and pig claims

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

1CYC001

100ml

12

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 52

www.bimeda.ie

TECHNICAL INFORMATION

CYCLOSOL LA 200 mg/ml SOLUTION FOR INJECTION Presentation A yellow to reddish-brown solution for injection. Each ml contains: Oxytetracycline 200mg Sodium formaldehyde sulphoxylate dehydrate 5mg Target Species Cattle and pigs.

Uses Cyclosol LA is indicated for the treatment of infections caused by oxytetracycline sensitive microorganisms. Oxytetracycline exerts its action by inhibiting the protein synthesisof the bacterial cell especially cell-division and the formation of the cell wall are impaired.

Contraindications, warnings etc.

Do not use in animals with known hypersensitivity to the active substance. In case of a serious anaphylactic reaction the administration of epinephrine, antihistamines and/ or corticosteroids should be considered.

Do not use by intravenous route.

Do not use in animals with serious kidney and liver disturbances.

Irritation may occur at the injection site for up to 4 days.

Use of the product during pregnancy can result in tooth discolouration in the offspring of treated animals.

Oxytetracycline should not be administered simultaneously with penicillins, cephalosporins, polyvalent cations or neuromuscular blocking agents.

Dosage and Administration

It is strongly recommended to divide the intramuscular dosages over two or more injection site. Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to oxytetracycline and may decrease the effectiveness of treatment with tetracyclines, due to the potential for cross resistance.

Cyclosol LA is indicated for (deep) intramuscular injection.

20 mg oxytetracycline per kg bodyweight.

1 ml per 10 kg bodyweight.

To ensure a correct dosage, bodyweight should be determined as accurately as possible.

Avoid more than 15 ml per injection site in cows.

If necessary, the treatment should be repeated after 72 hours.

Overdose Tetracyclines are generally well tolerated after acute overdoses.

Long-term treatment may result in gastrointestinal disturbances and changes of gut flora (suprainfections). Chronic overdose may lead to drug accumulation and nephrotoxicity. When used according to our recommendations none of these adverse effects will occur.

Cattle: meat and offal: 30 days milk: 12 days Pigs: meat and offal: 30 days Incompatibilities Do not mix with any other medicinal products.

Shelf-life Shelf-life of the veterinary medicinal product as packaged for sale: 36 months Shelf-life after first opening the immediate packaging: 28 days Special precautions for storage Do not store above 25째C. Protect from light. Do not freeze.

Disposal Any unused product or waste materials should be disposed of in accordance with national requirements.

Packaging 100ml Type II glass vials.

LEGAL CATEGORY POM VPA 10989/026/001

Withdrawal Period(s)

www.bimeda.ie 53

PRODUCT INFORMATION

CYPERGUARD

Cypermethrin High Cis 10% w/w per ml INDICATIONS • Non organophosphate Sheep Dip • Treats and prevents blowfly strike, lice, sheep keds and sheep scab at a single dipping • Provides up to 9 weeks protection againist blow fly strike

BENEFITS • Non OP sheep dip, safe for user and animal • Treats and prevents blowfly strike, lice, keds and sheep scab at a single dipping • Excellent tick control and reduces re-infestation • Cost effective per ewe treated in a plunge dip • Short withdrawal and economical to use

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

1CYP003

1L

12

1CYP004

2L

12

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 54

www.bimeda.ie

TECHNICAL INFORMATION

CYPERGUARD Cypermethrin High Cis 10% w/w per ml Presentation

A pale yellow, clear, water miscible micro emulsion concentrate containing cypermethrin (cis/trans 80/20) 10% w/w, for dilution with water before use.

Uses

For the prevention and treatment of blowfly strike, lice, keds and ticks on sheep by plunge dipping after dilution of the product with water. For the prevention and treatment of sheep scab caused by pyrethroid sensitive mites.

Dosage and Administration

For blowfly, keds, ticks, lice and sheep scab.

Initial dilution rate: 1 litre of dip to 500 litres water Replenishment: 1 litre of dip to 500 litres water. Do not dilute the product until it is actually required.

To Prepare the Bath Baths should be accurately calibrated. Fill the bath with the required quantity of clean water. Pour the required measured volume of dip directly into the bath to give the required strength at a rate of 2 Litres of Cyperguard per 1000 litres (220 gallons) of water.

Stir the bath thoroughly from end to end to ensure complete mixing.

Replenishment Replenish after every 50 sheep dipped. The bath should be topped up to its original volume with water. Then add 20ml of dip concentrate for each 10 Litres of water added.

Dipping Blowfly, Tick, Lice and Keds Immerse the sheep in the bath until the fleece is completely saturated with dip wash. All parts of the sheep except the head and ears must remain immersed for not less than thirty seconds. Plunge the head under at least twice, allowing time to breathe between plunges.

To reduce the risk of Blowfly strike, control worms and treat all wounds. Skim off at regular intervals any scum which may form on the surface of the dipping bath.

Blowfly A single treatment will provide up to 9 weeks control of Blowfly strike. Occasionally retreatment may be necessary after 4 to 9 weeks depending on the level of challenge, weather conditions, and timing of the first dipping.

Sheep Scab, Its Cure and Prevention For the purposes of dipping against sheep scab, sheep must be totally immersed in a sheep bath of an approved sheep dip, and all parts of the sheep except the head and ears must remain immersed in the bath for a period which shall in no case be less than one minute. Plunge the head under at least once. To Prevent Fouling of the Bath It is important that the dip bath is emptied and thoroughly clean at the end of each days dipping or earlier if it becomes very dirty during the days dipping. Dip no more than one sheep for every 2 litres of the initial bath volume before the bath is completely emptied.

Contra-indications, Warnings etc.

Sheep should never be dipped on a full stomach, when the wool is wet, or when they are heated, tired, thirsty or suffering from wounds or open sores. Do not use where there is known hypersensitivity to the active ingredient. For best results sheep should not be dipped soon after shearing, but should have at least 3 weeks growth of wool. Choose a cool, dry day and dip early in the morning. Rest sheep 2 or 3 hours before dipping. Rams and fat sheep should be assisted through the bath and lambs dipped separately from the ewes. Care should be taken to ensure that the sheep do not swallow or inhale any wash. After dipping, sheep should be allowed to

stand in a bare, open space, under shade if possible, but never in an enclosed building. Do not dilute the product until it is actually required.

Withholding Periods

Following treatment with Cyperguard Sheep Dip, sheep may not be slaughtered for human consumption for 14 days. Animals must not be slaughtered for human consumption during treatment. The product must not be used on sheep producing milk for human consumption.

To Avoid Post Dipping Lameness Post dipping lameness may occur when the sheep are dipped in dirty wash, or wash which has been allowed to stand in the bath overnight or longer. It is important that the dip bath should be emptied and thoroughly cleaned at the end of each days dipping or earlier if it becomes very dirty during the days dipping. SPECIAL SAFETY PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT TO ANIMALS: Minimise operator contamination by good dipping facility design, eg fit splash boards where operators stand. Ensure that those using dips are competent to do so.

1 When handling concentrate including dip replenishment: 1 Do not use in an enclosed area and avoid inhaling vapour.

2 Wear non-lined, synthetic rubber gloves (heavyduty gauntlet style nitrile at least 300mm in length and 0.5mm thick), wellington boots, waterproof (made of nitrile or PVC) trousers or leggings and coat or bib-apron and a face shield when handling the concentrate.

3 Wash splashes of the dip concentrate from the skin and eyes and from protective clothing and equipment immediately.

4 Remove heavily contaminated clothing immediately and wash or destroy.

2 When working with diluted dips and freshly dipped sheep: 1 Dipping should only be carried out in a well ventilated area, preferably outdoors.

2 Wear non-lined, synthetic rubber gloves (heavyduty gauntlet style nitrile at least 300mm in length and 0.5mm thick) wellington boots, waterproof (made of nitrile or PVC) trousers or leggings and coat or bib-apron.

3 Accidental splashes on exposed skin should be washed off immediately.

Wash hands, face and exposed skin immediately after leaving the work area, eg after dipping or for meal breaks.

4 Do not smoke, drink or eat during dipping without first withdrawing from the work area, removing protective clothing and washing hands, face and exposed skin.

5 Remove heavily contaminated clothing immediately and wash or destroy.

6 Check and replace any worn or damaged items or protective clothing. Wash measuring and dipping equipment after use. Protective clothing should be washed each day after dipping operations to prevent build up of chemicals in the materials.

3 Handling sheep in the weeks following dipping: Handle sheep as little as possible after dipping as dip residues remain on the sheep for some weeks following dipping.

If you need to handle sheep, wear coveralls and wellington boots. If the sheep are wet, wear waterproof trousers and coat or bib-apron and wellington boots.

Always wash hands and exposed skin with soap and

water after handling sheep or fleece and before eating, drinking and smoking.

4 Medical advice to users and doctors: Please note that Cyperguard is a nonorganophosphorus sheep dip.

This product contains cypermethrin which is a synthetic pyrethroid. Cypermethrin is a potential skin sensitiser and may induce paraesthesia or tingling effects on exposed areas of human skin.

Wash all accidental spillages of the concentrate and diluted dip off the skin immediately. If you feel unwell after working with this product consult your doctor and show this label. Doctors can obtain advice on clinical management from the Poisons Information Centre

Protection of the Environment

1 Dangerous to fish and other aquatic life.

2 Do not contaminate water including ponds, ditches, ground and surface waters.

It is an offence to permit any poisonous, noxious or polluting matter to enter any river, stream or watercourse.

3. In order to protect aquatic life, it is important to ensure that sheep have an area where dip can drip from the fleece and drain back into the bath immediately after dipping and also that sheep do not enter or cross water courses while the fleece is still wet. Do not dip sheep near a watercourse.

4. Empty containers should not be re-used. Wash out thoroughly and place rinsings into the dip bath. Dispose of containers by approved means.

Keep out of reach and sight of children and animals.

5. Only buy sufficient product for your immediate needs. Do not dispose of the dip concentrate on the farm. Any undiluted product should be disposed of by a reputable specialist waste disposal contractor.

6. Do not use soakaways as a means of disposal. If you have a suitable area of land, the spent dip wash may be disposed of by applying no more than 5,000 litres/hectare (450 gallons/acre) making sure that it cannot enter rivers, streams or lakes by run-off. Dilution of 1 part dip by 3 or more parts of water or slurry may be necessary to achieve this application rate.

Remove livestock from the land before spreading. Alternatively, the spent dip should be disposed of by a reputable waste disposal contractor.

HARMFUL IN CONTACT WITH SKIN AND IF SWALLOWED. IRRITATING TO EYES AND SKIN. FOR EXTERNAL USE ONLY. FOR ANIMAL TREATMENT ONLY. KEEP OUT OF REACH AND SIGHT OF CHILDREN.

Pharmaceutical Precautions

Do not store above 25째C. Protect from light.

Do not mix with any product.

Store in original container, tightly closed in a safe place under lock and key in a press dedicated to approved insecticides.

Do not store diluted dip wash overnight. Discard the diluted product after the days dipping.

Legal Category

LM

Package Quantities 1 litre and 2 litre

VPA 10960/31/1

www.bimeda.ie 55

PRODUCT INFORMATION

DIPEN

Procaine Penicillin 200mg & Dihydrostreptomycin 200mg/m INDICATIONS • For the treatment of infections caused by bacteria sensitive to penicillin and dihydrostreptomycin in cattle, sheep and pigs.

BENEFITS • Proven Procaine Penicillin and Dihydrostreptomycin sulphate combination • Broad Spectrum antibiotic For use in cattle, sheep and horses • Low dosage at a rate of 1ml per 25kg for easy intramuscular administration • For the treatment of systemic infections caused by or associated with organisms sensitive to penicillin and/or streptomycin • Penicillin reaches peak plasma levels and maintains therapeutic levels for up to 48 hours in cattle and sheep

PACKAGING LIST NO.

UNIT PACKAGE

CASE SIZE

???

100ml

12

See reverse side for full indications, administration and dosage.

Bimeda® Broomhill Road Tallaght Dublin 24, Ireland Tel: 1850-515253 56

www.bimeda.ie

TECHNICAL INFORMATION

DIPEN Presentation The product is a white to off-white sterile aqueous suspension for injection.

Each ml contains: Procaine Penicillin 200 mg (equivalent of 200,000 IU) Dihydrostreptomycin sulphate 200 mg Methylhydroxybenzoate 1.0 mg Uses For the treatment of infections caused by bacteria sensitive to penicillin and dihydrostreptomycin in cattle, sheep and pigs.

Dosage and Administration The recommended dose is 4 ml per 100 kg bodyweight i.e. 8,000 IU procaine penicillin and 10 mg dihydrostreptomycin sulphate per kg. Dipen is to be administered by sterile intramuscular administration only. Clean the area of injection and swab with spirit.

Dose Rate per Species (ml) kg Bodyweight Cattle 4.0 100 Sheep 1.0 25 Sow 3.0 75 Piglet 0.2 5 Do not exceed the stated dose

Contraindications and warnings Do not administer to animals known to be sensitive to penicillin. Do not use when it is known that penicillinase-producing staphylococcus organisms are present.

Occasionally in sucking and fattening pigs, administration of products containing procaine penicillin may cause a transient pyrexia, vomiting, shivering, listlessness and incoordination. In pregnant sows and gilts a vulval discharge which could be associated with abortion has been reported. The maximum dose volume recommended at any one site for cattle is 20 ml.

Withdrawal periods Withdrawal Period(s): Cattle: Meat : 21 days. Milk: 72 hours.

Sheep: Meat: 21 days Milk: Not to be used in lactating ewes producing milk for human consumption.

Pigs: Meat: 21 days.

Animals are not to be slaughtered to produce meat for human consumption during treatment. Milk for human consumption is not to be taken from cows during treatment.

Pharmaceutical Information and Precautions Contraindications: Do not administer to animals known to be sensitive to penicillin. Do not use when it is known that penicillinaseproducing staphylococcus organisms are

present. Special warnings: Occasionally in sucking and fattening pigs, administration of products containing procaine penicillin may cause a transient pyrexia, vomiting, shivering, listlessness and incoordination. In pregnant sows and gilts a vulval discharge which could be associated with abortion has been reported. The maximum dose volume recommended at any one site for cattle is 20ml.

Special precautions for use in animals: Not for use in lactating ewes producing milk for human consumption.

Special precautions to be taken by the person administering the veterinary medicinal product to animals Penicillin and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact.

Hypersensitivity to penicillin may lead to cross sensitivity to cephalosporins and vice versa.

Allergic reaction to those substances can occasionally be serious.

Do not handle this product if you know you are sensitised or if you have been advised not to work with such preparations. Handle this product with great care to avoid exposure, taking all recommended precautions. If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips and eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.

Adverse reactions: Occasional allergies to penicillins have been observed but these are very rare. Hypersensitivity (allergic) reactions to penicillins can vary from localised swelling to anaphylaxis and death. Occasionally in sucking and fattening pigs administration of products containing procaine penicillin may cause transient pyrexia, vomiting, shivering, listlessness and incoordination. In pregnant sows and gilts a vulval discharge which could be associated with abortion has been reported. Procaine penicillin G can, under certain circumstances, be toxic and even lethal to pigs and this is thought to be due to a sudden release of toxic amounts of free procaine. The symptoms include shivering, lassitude, inappetence, vomiting, cyanosis of the extremities and pronounced pyrexia (40째C and over). A vulval discharge may appear and some animals may abort. Alarming sideeffects are most likely to occur when pigs with erysipelas are injected with an older and, or,

heataffected procaine penicillin formulation. Treatment with 5 mg dexamethasone will result in rapid recovery.

Use during pregnancy, lactation or lay: Procaine penicillin and dihydrostreptomycin are safe for use in pregnant animals. Not for use in lactating ewes producing milk for human consumption. Interaction with other medicinal products and other forms of interaction: Tetracyclines are bacteriostatic antibiotics that presumably may interfere with a bactericidal agent such as penicillin. Since penicillin acts by inhibiting cell wall synthesis, agents such as tetracyclines, which inhibit protein synthesis, could mask the bactericidal effect of penicillin. If penicillin is used with a tetracycline, it would be prudent to observe the following points when possible: Be sure that adequate amounts of each agent are given; antagonism is most likely to occur when barely sufficient amounts of each agent are given. Begin administration of the penicillin at least a few hours before the administration of tetracycline.

Shelf-life The shelf life is two years from the date of manufacture. Once a vial is broached, use the contents within four weeks.

Special precautions for storage Do not store above 25째C. Do not freeze.

Nature and composition of immediate packaging: Type II, Siliconised clear glass, 100 ml vials containing closed with rubber stoppers and sealed with aluminium seals. Special precautions for the disposal of unused veterinary medicinal products or waste materials: Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste under national disposal regulations.

Legal Category POM Marketing authorisation holder CrossVetpharm Ltd (trading as Bimeda), Broomhill Road, Tallaght, Dublin 24.

Marketing authorisation number VPA: 10960/062/001

www.bimeda.ie 57

PRODUCT INFORMATION

D-MITE INDICATIONS • Control of Environmental levels of Redmite (Dermanyssus gallinae) within poultry units • Acts as a sticky trap for the mite, preventing movement and causing starvation • Mechanical mode of action, resistance not an issue

BENEFITS • Affects the mite like a sticky trap • Resistance is not an issue • Safe to apply and effective for 12 weeks after application • Safe for use by farm personnel • Can be used when chickens in house • No egg or meat withdrawal after application • Suitable for application using all spraying and misting systems

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

IDMT001

2 x 5L

12

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 58

www.bimeda.ie

TECHNICAL INFORMATION

D-MITE Presentation Presentation; 10L (2x 5L containers), Part A containing Dimethicone, Part B containing Spreading Agent (Turbomite).

Uses Suitable for all types of poultry systems Control of Environmental levels of Redmite (Dermanyssus gallinae) within poultry units.

Acts as a sticky trap for the mite, preventing movement and causing starvation Dosage and Administration • 125ml Part A and 125ml Part B added to 1L of water, thus 1L Part A and 1L Part B added to 8L of water to make 10L of spray solution. For greater volumes adjust the amounts of Part A and Part B accordingly.

Stir/ shake the mixture thoroughly.

Once mixed use within twelve hours.

• Depending on the type of house and the internal configuration within the house that is selected, as the Trial House, the application regime will vary.

• Caged houses: start spraying the uppermost cages and work along the upper level in the being sprayed and then moving down a level once the end of the row is reached.

• All surfaces, where red mites are normally found during the day (when they have left the birds) and surrounding area such, under drinkers/feeding troughs, upright posts etc should be thoroughly sprayed.

• As sizes of cages will vary, it is not possible to determine exactly how much of the working solution of D-Mite should be sprayed, but a good estimate is 11.7ml per bird or 1 litre for each 85 birds.

• Barn type houses where the birds are not caged, the following areas should be treated.

• Always start at the highest point where the birds frequent (such as perches, nest boxes etc) and apply the spray along the highest level first, working downwards, ensuring coverage of all roosting areas and laying boxes as well as any other areas where mite are known to congregate. Pay particular attention to cracks and crevices in slatted floors, where spray should also be applied. The application rate can be adjusted depending on the level of debris matter etc present, but it is recommended that a minimum of 1 litre of working solution be applied per 20 square metres of surface being treated.

Contra-indications, Warnings, etc.

Safe for use when poultry present Do not directly spray birds Due to the oily nature of the ingredients some surfaces could be slightly slip before they dry.

Take necessary precautions if this is the case.

Products Directive 98/8/EC D-Mite Part A should always be used as directed below with D-Mite Part B. It must not be mixed with any other product.

Part B causes- Skin Irritation -Serious Eye Irritation.

Do not get in eyes, on skin or on clothing.

Wear protective gloves + protective clothing +eyeprotection+ face protection.

In case of contact with eyes rince immediately with plenty of water and seek medical advice.

Wash Hands after spraying.

Keep away from children.

Marketing authorisation holder Cross Vetpharm Group Ltd. (trading as Bimeda), Broomhill Road, Tallaght, Dublin 24.

Marketing authorisation number N/A

Withdrawal periods Eggs zero withdrawal Meat zero withdrawal Pharmaceutical Information and Precautions D-Mite Part A contains a patented combination of Siloxanes which is an effective control of Red Mite.

D-Mite Part B acts as a cleaner and spreading agent.

Part B contains Quaternary ammonium compounds with a blend of cationic, amphoteric and non-ionic surface active agents and waterconditioners with additional poly(hexamethylenebiguanide) hydrochloride Exempted from the requirements of the Biocidal

www.bimeda.ie 59

PRODUCT INFORMATION

ECTOSPEC

Cypermethrin Technical 2.5%w/v INDICATIONS For the control of lice and flies on cattle.

BENEFITS • Ready to use insecticide for cattle • For fly and lice control in cattle • No milk withdrawal period • 10 days meat withdrawal • Low dose rate 10ml/treatment

PACKAGING

® ® Bimeda Bimeda

Broomhill Broomhill Road Road

LIST NO.

UNIT PACKAGE

CASE SIZE

1ECT001

500ml

12

1ECT002

2.5L

4

See reverse side for full indications, administration and dosage.

Tallaght Tallaght Dublin Dublin 24,24, Ireland Ireland Tel: Tel: 1850-515253 1850-515253 60

www.bimeda.ie

TECHNICAL INFORMATION

ECTOSPEC Cypermethrin Technical 2.5%w/v Presentation A clear, pale yellow, oily solution containing a 2.5% w/v Cypermethrin technical (93%) (cis:trans 50:50) for topical administration as a pour on application.

Uses For the control of lice and flies on cattle.

Dosage and Administration For topical administration as a pour on.

Fly control Apply a single 10ml dose at the onset of the fly season and repeat as necessary at 5 to 8 week intervals. Frequency of administration may, however, have to be varied depending on the level and type of infestation.

The 10ml dose should be applied at an even rate along the backline from the crown of the head to the top of the rump.

Lice Control A single 10ml dose is normally sufficient to control lice. A few lice may survive on a small minority of animals. In cases of heavy challenge, if necessary, a repeat dose may be applied after 4 weeks.

Remove the cap from the chamber and gently squeeze the required amount into the chamber. Release the pressure from the container and pour as directed. The 10ml dose should be applied at an even rate along the backline from the crown of the head to the top of the rump.

Contra-indications, Warnings, etc.

For animal treatment only.

Do not treat calves under 7 days of age. Not to be used in animals known to be sensitive to the active ingredient.

Undesirable Effects (General) Occasionally, slight signs of discomfort may be observed in some cattle during the 48 hours following application. These side effects are only temporary and have no long-term implications.

Use during Pregnancy and Lactation The active has a low oral toxicity and very little transdermal absorption is expected, and to date there has been no reported complications in pregnancy or lactation.

Interaction with Other Medicaments and other Forms of interactions It is not anticipated that Ectospec will interact with any of the medicines commonly administered to cattle.

Protection of Operators Ectospec should be administered in a well ventilated area. Protective clothing, including rubber gloves and rubber boots, should be worn and any accidental splashes on skin or eyes should be washed off immediately. Do not eat, drink or smoke when applying Ectospec.

Wash hands and any exposed skin before eating, drinking or smoking and immediately after application has finished.

Special precautions for use Dangerous to fish and other aquatic animals. Do not contaminate ponds, waterways or ditches with the product or used containers.

Unused product or containers should be disposed of in accordance with current practice for pharmaceutical waste under national waste disposal regulations.

Overdose Care should be taken not to overdose. Overdosing may invalidate the stated milk and meat withholding times.

Withdrawal Periods Animals must not be slaughtered for human consumption during treatment. Treated animals should not be slaughtered for human consumption for a period of 10 days after treatment.

No withdrawal time is necessary for milk, although cows should be treated immediately after milking to allow as long a time as possible to elapse before the next milking.

Pharmaceutical Precautions Incompatible with alkali materials Do not store above 25째C. Keep out of reach and sight of children.

Legal Category LM Package Quantities 500ml multidose and 2.5L containers Marketing Authorisation Number 10959/10/1

www.bimeda.ie 61

PRODUCT INFORMATION

ECTOFLITS

60 % w/w Diazinon active INDICATIONS

• Sheep: For the prevention and treatment of Blowfly Strike, Keds, Lice, and Scab infestations

BENEFITS • Approved for the control of sheep scab, fly strike,lice and keds in one treatment • 35 Day meat withhold • 3L Can dips 500 sheep • Cost effective • Improved flock performance • 1:1500 Dilution • Dispensing kit available for safe handling

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

1ECT003

3L

1

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 62

www.bimeda.ie

TECHNICAL INFORMATION

ECTOFLITS Presentation A clear yellow coloured liquid containing Diazinon 60% w/v TARGET SPECIES Sheep.

INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Sheep: For the prevention and treatment of Blowfly Strike, Ticks, Keds, Lice, and Scab infestations.

CONTRAINDICATIONS None SPECIAL WARNINGS FOR TARGET SPECIES Sheep should never be dipped on a full stomach, when the wool is wet, or when they are heated, tired, thirsty, or suffering from wounds or open sores. Choose a cool dry day and dip early in the morning.

Rams and fat sheep should be assisted through the bath and lambs dipped separately from the ewes. Care should be taken to ensure that the sheep do not swallow or inhale any wash. As this is an organophosphorus sheep dip, an interval of at least 14 days should elapse between dipping and dosing with any drench, etc. containing levamisole or an organophosphorus compound.

TO AVOID POST DIPPING LAMENESS Post dipping lameness may occur when the sheep are dipped in dirty wash, or wash which has been allowed to stand in the bath overnight or longer. It is important that the dip bath should be emptied and thoroughly cleaned at the end of each days dipping or earlier if it becomes very dirty during the day’s dipping.

SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals For external use only.

One pair of gloves, one laminated dispensing kit instruction card and one laminated sheep dipping safety card are supplied with each container of Ectoflits.

The dip concentrate container is fitted with a sealed closure incorporating a male inlet Quick Acting Shut-off coupling (QASC), a female outlet QASC and a draw tube that extends from beneath the outlet QASC to the marked corner of the container. When the container is fitted correctly into the dispensing kit, the tilt mechanism allows withdrawal of the maximum amount of dip concentrate from the container. The dip concentrate in the container must be dispensed directly into the dip tank only by using the Ectoflits Dispensing Kit. Follow the instructions provided with the dispensing kit for fitting it onto the container and for dispensing the dip concentrate safely.

A re-usable dispensing kit must be purchased in order to use Ectoflit Sheep dip. Each kit must contain the following components: · 1x dispensing gun with tubing and 2x connectors (1x male and 1x female) attached, · 1x dispensing base-plate plus

1x dispensing tube with 1x female connector attached and 1x rinsing tube with 1x male connector and 1x non-return valve attached, · 1x laminated card, bearing instructions for the correct use of the dispensing kit.

The product must be dispensed only by use of this kit, in accordance with the instructions on the dispensing kit laminated instruction card. If part-used containers of the product are to be kept for future use, the dispensing kit must be removed, washed and stored as per the instructions, and the original cap must be replaced securely on the product container. The dispensing kit must not be used for any other purpose.

The instructions for use of the dispensing kit read as follows: Ectoflits concentrate must be dispensed only by using this kit. Read the directions for use printed on the product container before using this kit. It is essential that the advice on wearing protective clothing is strictly adhered to at all times when handling new or part-used containers of sheep dip concentrate, when using the dispensing kit and when washing used concentrate containers and the dispensing kit. This kit is re-usable. It should not be used for any other purpose.

It should be washed and stored as directed on the instruction card.

DISPENSING DIP PRODUCT i) Preparation for dipping. Place the dip concentrate container into the cage on the base-plate so that the coloured corner of the container label is aligned with the coloured corner of the base-plate. This will tilt the container to allow withdrawal of the maximum amount of dip concentrate. Place the dispensing base-plate on level ground at the edge of the dip tank and feed the dispensing hose through the hole in the base-plate so that the hose hangs down into the dip tank. Where splashboards are fitted the base-plate should be sited so that the dispensing hose is fed through an existing gap in the barrier.

For extra security the baseplate can be attached to a solid object near to the edge of the dip tank using twine or wire threaded through the cage at the rear of the base plate. ii) Initial fill of dip concentrate into dip bath (see Fig. A): Connect gun inlet hose (2) to container outlet valve (1) and connect gun outlet (3) to dispensing hose (5). Carefully pump the trigger of the gun until the gun reservoir and outlet tubes are full of product. Then dispense the required number of 60 ml volumes of dip concentrate for initial charging of the dip tank (see container label for details). The dispensing gun is fixed to deliver 60 ml only and is sealed for safety reasons. It must not be disassembled. When filling the gun reservoir, to ensure accuracy, it is important to wait until the plunger has returned completely before dispensing the dip concentrate. It is recommended that the operator keeps a tally of the number of volumes dispensed. After every ten x 60

ml dispensings, using a dry gloved finger, press down on the top of container inlet valve (4) for a few seconds (see Fig. B).

This is to allow air to enter the container to relieve any negative pressure. iii) Replenishment of dip bath with product: (see Figures A & B) Replenishment with one 60 ml delivery of concentrate treats 12 sheep. Baths less than 2250 litres (500 gallons) must be replenished after every 36 sheep dipped (3x60 ml deliveries from the dispensing gun) and the bath must be filled with water to its original level. Baths of 2250 litres (500 gallons) or more must be replenished after every 96 sheep dipped (8x60 ml deliveries from the dispensing gun) and the bath must be filled with water to its original level.

Approaching the end of the days dipping, when replenishing the dip bath for the final time, carry out the first 1x60 ml delivery for a bath less than 2250 litres (or the first 6x60 ml deliveries for a bath greater than 2250 litres) and allow the gun to refill by releasing the trigger. Then disconnect gun inlet hose (2) from container outlet valve (1) and connect gun inlet hose (2) to hose (6) ensuring that the non-return valve (7) on the end of the hose is secured to the clip (8) on the carrying handle (see Fig. C). Now pump the gun two more times and the final 120 ml of dip concentrate will be delivered into the dip bath. Replace transit cap onto the part used container. Now follow instructions on how to wash and store the dispensing kit (see ‘Washing Instructions’). iv) To change containers during dipping: If a container is emptied during dipping disconnect gun inlet hose (2) from empty container outlet valve (1). Immediately re-connect to a new container and carefully pump the trigger of the gun until the reservoir is full. When disconnected, do not try to operate the delivery gun until the correct connections (step ii) have been made. Store the empty container safely until the end of the day’s dipping. Do not rinse empty containers until the end of the day’s dipping (see ‘Washing Instructions’). This is to avoid the possibility of the introduction of water into part-filled dip concentrate containers. Even very small amounts of water can affect the long-term stability of the dip concentrate.

LEGAL CATEGORY

LM

www.bimeda.ie 63

PRODUCT INFORMATION

ECTOFLY 1.25% w/v Pour-On Solution Cypermethrin INDICATIONS For the prevention and treatment of blowfly strike on sheep. Also used for the treatment and control of headflies and treatment of ticks and biting lice on sheep.

BENEFITS • 6-8 weeks blowfly strike • Proven Formulation • Short 8 day meat withhold period • Can be used all year round • Contains 48 hour blue dye

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

8ECT008

5L

4

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 64

www.bimeda.ie

TECHNICAL INFORMATION

ECTOFLY

1.25% w/v Pour-On Solution

1. Presentation A clear blue non-aqueous solution containing 1.25%w/v High Cis (80:20) Cypermethrin for the prevention and treatment of Blowfly Strike, Lice, Ticks and Headflies on Sheep.

2. CLINICAL PARTICULARS 2.1 Target Species Sheep.

2.2 Indications for use, Specifying the Target Species For the treatment and control of headflies, and treatment of ticks and biting lice in sheep. For the prevention and treatment of blowfly strike in sheep.

2.3 Contraindications Not to be used in lambs less than one week old. For the prevention of blowfly strike; do not administer to animals of less than 12.5 kg bodyweight. Avoid treating very young lambs if the weather is unseasonably hot.

2.4 Special Warnings for Each Target Species None 2.5 Special Precautions For Use i) Special precautions for use in animals Ectofly 1.25% w/v Pour-On minimises mothering-up problems after treatment.

However, care must be taken not to apply the product right to the lamb’s tail, as a ewe recognises a young lamb partly by the smell of the tail area.

Blowflies are attracted by dirty, damp wool or open wounds. The more common site for fly strike is the rump due to soiling caused by diarrhoea and urine staining.

The efficacy of Ectofly 1.25% w/v Pour-On is reduced in the presence of soiled or dirty wool. Therefore, sheep must be crutched (dagged) regularly and appropriate worm control measures employed. Take care not to apply product in the sheep’s eyes.

This precaution should be observed particularly when treating breeds with little wool on their heads. Full operating and maintenance instructions, including details on the use of nozzles are supplied with each applicator gun. Please read carefully before use. Maintain applicator gun carefully to ensure accurate dosage.

For external use only. ii) Special Precautions to be taken by the person administering the product to animals Make sure when attaching the recommended applicator gun onto the container that the coiled retainer is secured onto the cap and the applicator.

Wear eye protection, protective clothing, rubber gloves and boots when applying the product. Wear a dust mask when applying as a fan-spray for the prevention of blowfly-strike. Wash splashes from skin and eyes immediately with plenty of clean water. If irritation persists seek medical advice immediately Remove contaminated clothing immediately and wash exposed skin with plenty of clean water. Do not eat, drink or smoke whilst using the product.

Wash hands and exposed skin before eating, drinking or smoking and after work.

Use in a well-ventilated area and avoid inhaling the vapour. iii) Other precautions As a precautionary measure sheep must be kept away from watercourses for at least one hour following treatment (see section 5.3, ‘Environmental properties).

2.6 Adverse Reactions (frequency and seriousness) None known.

2.7 Use during pregnancy or lactation No restrictions. Pregnant ewes must be handled with care.

2.8 Interaction with other medicinal products and other forms of interaction The product must be applied only with the recommended applicator gun, as the product may have a detrimental effect on certain components of conventional dosing guns.

2.9 Amounts to be administered and administration route On completion of each treatment cycle of the product and before the dosing gun is stored, immediately expel any remaining product in the dosing gun.

Administer by means of the recommended applicator gun as follows: Blowflies: PREVENTION OF BLOWFLY STRIKE Bodyweight Dose Doses per litre Up to 25 kg* 20 ml 50 25 to 40 kg 30 ml 33 Over 40 kg 40 ml 25 *Do not administer to animals of less than 12.5 kg bodyweight.

Apply as a fan-spray to the surface of the fleece on the back and hindquarters of the sheep using the Pour-On Gun fitted with the fan-spray nozzle. Half the dose should be applied to the shoulders, back and flanks, and half to the rump. The distance between the nozzle and the fleece should be approximately 20 cm.

Each dose will require 2 or 3 sweeps to apply. THE PRODUCT WILL PREVENT BLOWFLY STRIKE ONLY ON AREAS COVERED BY SPRAY. One application will give 6-8 weeks protection. Re-treat as required.

Treatment of blowfly strike Apply directly to all the affected parts at the rate of 2.5 ml per 100 –150 cm2 (roughly the size of a hand). The T-bar nozzle should be used. Most strikes will require 5-10 ml. Ensure that all affected parts are treated. A single application is sufficient to ensure that larvae are expelled and killed within a few hours.

Lice: 5 ml per 20 kg bodyweight up to a maximum of 20 ml.

Bodyweight Up to 20 kg 21 to 40 kg 41 to 60 kg Over 60 kg

Dose 5 ml 10 ml 15 ml 20 ml

Doses per litre 200 100 66 50

Using the straight nozzle on the applicator gun, apply as a pin-stream from the shoulders to the rump along the middle of the backline.

Sheep may be treated off-shears or at any time during the year.

Ticks: Adult sheep and lambs greater than 10 kg: 10 ml per 20 kg bodyweight, up to a maximum of 40 ml. Lambs under 10 kg: 5 ml followed 3 weeks later by a 10 ml application.

Bodyweight Dose Up to 10 kg 5 ml 11 to 20 kg 10 ml 21 to 40 kg 20 ml 41 to 60 kg 30 ml Over 60 kg 40 ml

Doses per litre 200 100 50 33 25

Using the straight nozzle on the Pour-On Gun, apply as a pin-stream from the crown of the head to the top of the rump. Headflies: 5 ml per animal irrespective of size. Apply to the top of the head between the ears using the T-bar nozzle. Take care not to apply product in the sheep’s eyes. One application before the start of the headfly season will give up to 4 weeks protection.

Re-treat as required. This product contains a blue dye to aid in the identification of treated animals. The colour is temporary and will fade from the fleece within 48 hours of application. 2.10 Overdose Toxic signs in mammals are remors, hyperexcitability, salivation, choreoathetosis and paralysis, rarely leading to death. Usually, the signs disappear rapidly and the animals recover, generally within a week. There is no specific antidote but symptomatic therapy can be given if considered necessary.

2.11 Withdrawal Periods Meat and offal: 8 days. Milk: Not to be administered to animals producing milk for human consumption.

3. MARKETING AUTHORISATION HOLDER Cross Vetpharm Group Ltd. Broomhill Road, Tallaght, Dublin 24,Ireland.

4. MARKETING AUTHORISATION NUMBER N/A 5. DATE OF FIRST AUTHORISATION 5 April 2011 6. DATE OF THE REVISION OF THE TEXT April 2011 A full product spc is available on request from Bimeda or alternatively can be found on the VMD website

www.bimeda.ie 65

PRODUCT INFORMATION

EFICUR 50 mg/ml Ceftofur 50mg/ml INDICATIONS • Licensed for use in cattle and pigs • For the treatment of bacterial respiratory disease due to Mannheimia haemolytica, Pasteurella multocida and Haemophilus somnus in cattle. For the treatment of interdigital dermatitis (foot rot) due to Fusobacterium necrophorum. For the treatment of acute post-partum metritis in cows.

• For the use in the treatment of acute respiratory in pigs associated with Pasteurella multocida, Actinobacillus pleuropneumoniae and Streptococcus suis

BENEFITS • Excellent syringeability allowing product to be injected quicker, saving time and stress • Shortest withdrawal period of any cephalosporin- milk 0 days and meat 2 days • User friendly with subcutaneous administration route • 250ml plastic bottle for better protection and less breakages • Total bioavailability resulting in 100% of the anti biotic active for the volume administered

Bimeda® Broomhill Road

PACKAGING LIST NO.

UNIT PACKAGE

CASE SIZE

1EFI001

100ml

100

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 66

www.bimeda.ie

TECHNICAL INFORMATION

EFICUR 50 mg/ml suspension Ceftofur 50mg/ml Presentation

A white or yellowish oily suspension for injection in cattle and swine. 1ml contains Ceftiofur 50 mg (as Ceftiofur Hydrochloride)

Target Species Swine and cattle.

Use

Infections associated with bacteria sensitive to ceftiofur: Swine: - Treatment of bacterial respiratory disease associated with Pasteurella multocida, Actinobacillus pleuropneumoniae and Streptococcus suis.

Cattle: - For the treatment of bacterial respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida and Haemophilus somnus.

- For the treatment of acute interdigital necrobacillosis (panaritium, foot rot) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus (Phorphyromonas asaccharolytica).

- For the treatment of the bacterial component of acute post-partum (puerperal) metritis within 10 days after calving associated with Escherichia coli, Arcanobacterium pyogenes and Fusobacterium necrophorum.

Contra-indications, Warnings, etc.

Do not administer to an animal previously found to be hypersensitive to ceftiofur and other β-lactam antibiotics.

Do not inject intravenously

Special precautions for use

i) Special precautions for use in animals Shake the bottle well before use to bring the product back into suspension.

In case of the occurrence of allergic reaction the treatment should be withdrawn.

Inappropriate use of the product may increase the prevalence of bacteria resistant to cephalosporins.

Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies. ii) Special precaution to be taken by the person administering the

medicinal product to animals Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact.

Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.

People with known hypersensitivity to penicillins or cephalosporins should avoid contact with the product. In the case of accidental self-injection or following exposure, if you develop symptoms such as a skin rash, seek medical advice immediately and show the package leaflet or the label to the physician. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.

Adverse reactions (frequency and seriousness)

Hypersensitivity reactions unrelated to dose can occur. Allergic reactions (e.g. skin reactions, anaphylaxia) may occasionally occur.

In swine, mild reactions at the injection site, such as discoloration of the fascia or fat, have been observed in some animals for up to 20 days after injection.

In cattle, mild inflammatory reactions at the injection site, such as tissue oedema and discoloration of the subcutaneous tissue and/or fascial surface of the muscle may be observed. Clinical resolution is reached in most animals by 10 days after injection although slight tissue discoloration may persist for 28 days or more.

Use during pregnancy, lactation or lay

Studies in laboratory species have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Safety has not been established in the target species during pregnancy.

Use only according to the benefit/risk assessment by the responsible veterinarian.

Amounts to be administered and administration route Swine: 3 mg ceftiofur/kg bw/day for 3 days by intramuscular injection, i.e. 1 ml of the product /16 kg bw/day.

Cattle:

Treatment of respiratory disease: 1 mg ceftiofur/kg bw/day for 3 to 5 days by subcutaneous injection, i.e. 1 ml of the product /50kg bw/day.

Treatment of acute interdigital necrobacillosis: 1 mg ceftiofur/kg bw/day for 3 days by subcutaneous injection, i.e.

1 ml of the product/50 kg bw/day.

Acute post-partum metritis within 10 days after calving: 1 mg ceftiofur/ kg bw/day for 5 consecutive days by subcutaneous injection, i.e. 1 ml of the product /50 kg bw/day.

Subsequent injections must be given at different sites.

In case of acute post-partum metritis, additional supportive therapy might be required in some cases.

Shake well before use

Overdose (symptoms, emergency procedures, antidotes), if necessary

The low toxicity of ceftiofur has been demonstrated in swine using ceftiofur sodium at doses in excess of 8 times the recommended daily dose of ceftiofur intramuscularly administered for 15 consecutive days.

In cattle, no signs of systemic toxicity have been observed following substantial parenteral overdosages.

Withdrawal Period(s) Swine: - Meat and offal: 5 days.

Cattle: - Meat and offal: 8 days

List of excipients

Aluminium monostearate Sorbitan oleate Triglycerides, medium-chain products.

Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years Shelf life after first opening the immediate packaging: 28 days

Special precautions for storage Do not store above 25 ÂşC Do not refrigerate or freeze

LEGAL CATEGORY

POM

VPA 10846/006/001

www.bimeda.ie 67

PRODUCT INFORMATION

EMBOTAPE

Pyrantel embonate 11.4g/syringe INDICATIONS • Pyrantel embonate is a broad spectrum anthelmintic • Pyrantel embonate is indicated for use in the horse for the control and treatment of adult infections of large and small strongyles, Pinworms, Roundworms • Control and treatment of Anoplocephala (Tapeworm)

BENEFITS • For the treatment and control of adult imfections of large and small redworms ascarids and pinworms • For the treatment and control of tapeworm • Calibrated syringe for accurate dosage • Short withdrawal 7 days • Broad spectrum activity of pyrantel embonate

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

1EMB001

28.5G SYRINGE

20

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 68

www.bimeda.ie

TECHNICAL INFORMATION

EMBOTAPE Pyrantel embonate 11.4g/syringe Presentation

Embotape is a ready to administer oral wormer for horses and other equines.

Each 28.5g syringe contains Pyrantel Embonate 11.4g as active ingredient and Butylated Hydroxy Toluene 0.0057g as an anti-oxidant. Each 100kg dose contains 1.9g Pyrantel Embonate .

Uses

For the treatment and control of adult infections of large and small Redworms, Ascarids and Pinworms found in the gastro-intestinal tract of horses and other equines.

Embotape also treats and controls tapeworm infection.

Weight

Type

Routine Treatment

Up to 100kg

Miniature ponies

Syringe mark 100kg

101 - 300kg

Donkey, Shetland and other small ponies, foals

Syringe mark 300kg (½ syringe)

301 - 400kg

Dartmoor, New Forest, Welsh

Syringe mark 400kg

401 - 500kg

Light hunters, Arabs, etc.

Syringe mark 500kg

501 - 600kg

Thoroughbreds

Syringe mark 600kg (1 syringe)

601kg and over

Heavy hunters, draught horses

1 full syringe plus additional 100kg syringe marks for each extra 100kg bodyweight.

Dosage and Administration For direct oral administration only.

One syringe per 600kg bodyweight as a single dose (which is equivalent to one syringe mark per 100kg bodyweight).

Control and treatment of Strongyles, Oxyuris and Parascaris:

Embotape should be used at a dose rate of 19mg pyrantel embonate per kg bodyweight. The dosing programmes are as follows: A Foals (1 - 8 months of age): dose every 4 weeks.

B Horses (over 8 months of age): dose every 6 - 8 weeks, but during the summer and autumn when at grass dose every 4 - 6 weeks. Always dose 3 - 4 days before turning out after in-wintering.

C Suckler mares: It has been shown that reduction of strongyle challenge to the suckling foal at pasture can be achieved by using clean pasture (re-seeded or not grazed the previous year by horses), dosing the mare 3 - 4 days before turning out and then at intervals of 2 - 4 weeks until the end of Autumn. Ideally mares with foals should go out to clean pasture or, if this is not possible, delay turning them out until June.

The prescribed amount of Embotape is deposited on the tongue of the animal and the animal allowed to swallow. The complete content of one syringe contains 11.4g pyrantel embonate (6 graduated doses of 1.9g) in 28.5g paste and is sufficient for the treatment of 600kg bodyweight. Each graduation of the syringe is sufficient for the treatment of 100kg bodyweight.

Control and treatment of anoplocephala (tapeworm):

Embotape should be used at a dose rate of 38mg pyrantel embonate per kg bodyweight (ie twice the dose used for strongyles). The need for retreatment may vary, but if considered necessary, should be carried out after an interval of 6 weeks.

Contra-indications, Warnings, etc.

The same syringe should only be used to dose two animals if they are both healthy and are either grazing together, or are on the same premises and in direct contact with each other. Impaction of the small intestine may occur in foals heavily infected with Ascarids. Colic symptoms may be seen as soon as 30 minutes after treatment.

Do not use in severely debilitated animals.

Do not use in horses with known sensitivity to the active ingredient.

In case of diminished efficacy consult a veterinarian.

known to be hypersensitive to pyrantel.

Withdrawal Periods

Horses may be slaughtered for human consumption only after 7 days from the last treatment.

Storage Precautions

Keep out of reach and sight of children.

Protect from direct sunlight.

On occasions where only part of the paste is used, replace the cap and store as indicated.

Legal Category LM Package Quantities 28.5g syringe x 20.

VPA 10960/25/1

Operator Warnings

Combined administration of pyrantel and levamisole or piperazine is not recommended.

Avoid contact with skin; wash hands and any other parts of the body which come into contact with the product after use.

Avoid handling the product if you are

www.bimeda.ie 69

PRODUCT PRODUCT INFORMATION

ENDOSPEC 2.5% SC Albendazole 25mg/ml Selenium 0.27mg/ml Cobalt 0.624mg/ml

INDICATIONS A broad spectrum multi-purpose anthelmintic for the control of mature and developing immature forms of gastrointestinal roundworms, lungworms, tapeworms and adult liver fluke in cattle and sheep. The product is also ovicidal against fluke and roundworm eggs.

BENEFITS • Broad spectrum wormer for cattle and sheep • Dose designed for accurate and easier lamb dosing • 4 day meat withdrawal for sheep • Ovicidal, helping to control pasture re-infestation • Chronic fluke control dose available • Added selenium and cobalt

PACKAGING

Bimeda®® Bimeda Broomhill Broomhill Road Road Tallaght Tallaght Dublin 24, Ireland Dublin 24, Ireland Tel: 1850-515253 Fax: 01 451 5803 Tel: 1850-515253 70

LIST NO.

UNIT PACKAGE

1END010

2.5L

1END012

5L

1END008

10L

See reverse side for Administration and Dosage.

www.bimeda.ie www.bimeda.ie

TECHNICAL TECHNICAL INFORMATION INFORMATION

ENDOSPEC 2.5% SC

Albendazole 25mg/ml, Selenium 0.27mg/ml, Cobalt 0.624mg/ml PRESENTATION A pale green-coloured aqueous suspension for oral administration only. Each ml contains 25mg Albendazole, 0.27mg selenium (as sodium selenite) and 0.624mg cobalt (as cobalt sulphate).

TARGET SPECIES Cattle and sheep.

has been reported in Cooperia and Teladorsagia species in cattle in developed countries such as New Zealand. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.

SPECIAL PRECAUTIONS FOR USE

INDICATIONS FOR USE A broad spectrum multi-purpose anthelmintic for the control of mature and developing immature forms of gastrointestinal roundworms, lungworms,

i. SPECIAL PRECAUTIONS FOR USE IN ANIMALS Not to be diluted or mixed with other products.

Do not administer other cobalt and selenium

roundworm eggs.

advised by your veterinary surgeon.

Avoid the introduction of contamination during use.

The product should only be used in areas where

In cattle it is active against the following species: Roundworms: Ostertagia, Haemonchus, Trichostrongylus, Nematodirus, Oesophagostomum, Bunostomum, Cooperia and Strongyloides spp. It is usually effective against inhibited larvae of Cooperia and Ostertagia.

Lungworms: Dictyocaulus viviparus.

Tapeworms: Moniezia spp.

Adult Liver Fluke: Fasciola hepatica. roundworm eggs, contamination.

thus

reducing

pasture

In sheep it is active against benzimidazolesusceptible strains of the following species: Roundworms: Ostertagia, Haemonchus, Trichostrongylus, Nematodirus (including N. battus), Chabertia and Oesophagostomum. It is usually effective against inhibited larvae of Ostertagia.

Lungworms: Tapeworms: Moniezia spp.

Fasciola hepatica. roundworm eggs, contamination.

thus

reducing

pasture

CONTRAINDICATIONS Known hypersensitivity to the active ingredient.

SPECIAL WARNINGS FOR EACH TARGET SPECIES Cattle suffering from severe lung damage due to heavy lungworm infestation may continue to cough for some weeks after treatment.

Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy: Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.

Underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dosing device (if any).

Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

Resistance to benzimidazoles (which includes albendazole) has been reported in Cooperia, Haemonchus, Trichostrongylus, and Teladorsagia species in small ruminants in a number of countries, including the EU. Resistance to albendazole

occur. If in any doubt seek the advice of a veterinary surgeon.

Intensive use or misuse of anthelmintics can give rise to resistance. To reduce this risk, dosing programmes should be discussed with a veterinary surgeon.

Care must be taken not to damage the pharyngeal region when dosing, particularly in sheep. ii. SPECIAL PRECAUTIONS TO BE TAKEN

BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Avoid direct contact with the product. Wear suitable protective clothing including impermeable rubber gloves. thoroughly with running water.

If irritation persists, seek medical attention.

Wash hands after use.

ADVERSE REACTIONS None known USE DURING PREGNANCY, LACTATION OR LAY The use of the product in breeding bulls or pregnant cattle is not expected to interfere with their reproductive performance.

(7.5 mg/kg), during tupping or for 1 month after removing the rams. Can be safely used during lactation.

INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS None known.

AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTES: For oral administration only using properly calibrated dosing equipment.

To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked.

Shake the container before use.

Cattle: Worm dose: For the control of roundworms, lungworms, tapeworms Dosage: 7.5 mg albendazole per kg bodyweight.

Fluke and worm dose: For the additional in cattle.

Dosage: 10 mg albendazole per kg bodyweight.

Sheep: Worm dose: For the control of roundworms, eggs.

Dosage: 5 mg albendazole per kg bodyweight.

Fluke and worm dose: For the additional in sheep.

Dosage: 7.5 mg albendazole per kg bodyweight.

Administration with a suitable drenching gun is recommended OVERDOSE Not applicable.

WITHDRAWAL PERIODS Animals intended for human consumption must not be slaughtered during treatment. Cattle must not be slaughtered for human consumption until 14 days after the last treatment. Sheep must not be slaughtered for human consumption until 4 days after the last treatment. Milk intended for human consumption may be taken from cows only after 60 hours from the last treatment. Not for use in sheep producing milk for human consumption.

INCOMPATIBILITIES None Known SHELF LIFE Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25째C. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT AND WASTE MATERIAL, IF ANY DANGEROUS to aquatic life. Do not contaminate ponds, waterways or ditches with the product or used containers. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

MARKETING AUTHORISATION HOLDER Cross Vetpharm Group Ltd. Broomhill Road, Tallaght, Dublin 24. Ireland MARKETING AUTHORISATION NUMBER VPA 10960/028/001 LEGAL CATEGORY:

LM PACKAGE QUANTITIES: 2.5, 5 Litres and 10 Litres A full product SPC is available on request from Bimeda or alternatively can be found on the IMB website

www.bimeda.ie www.bimeda.ie

71

PRODUCT PRODUCT INFORMATION

ENDOSPEC 10% Albendazole 100mg/ml Selenium 1.08mg/ml Cobalt 2.5mg/ml

INDICATIONS A broad spectrum multi-purpose anthelmintic for the control of mature and developing immature forms of gastrointestinal roundworms, lungworms, tapeworms and adult liver fluke in cattle and sheep. The product is also ovicidal against fluke and roundworm eggs.

BENEFITS • Broad spectrum wormer for cattle and sheep • Low volume dose designed for accurate dosing of adult stock • Ovicidal, helping to control pasture re-infestation • Chronic fluke control-dose available • Added selenium and cobalt • Short withdrawals for meat and milk

PACKAGING

Bimeda®® Bimeda Broomhill Broomhill Road Road Tallaght Tallaght Dublin 24, Ireland Dublin 24, Ireland Tel: 1850-515253 Fax: 01 451 5803 Tel: 1850-515253 72

LIST NO.

UNIT PACKAGE

1END005

2.5L

1END007

5L

1END001

10L

See reverse side for Administration and Dosage.

www.bimeda.ie www.bimeda.ie

TECHNICAL TECHNICAL INFORMATION INFORMATION

ENDOSPEC 10%

Albendazole 100mg/ml, Selenium 1.08mg/ml, Cobalt 2.5mg/ml PRESENTATION A pale blue-coloured aqueous suspension for oral administration only. Each ml contains 100mg Albendazole, 1.08mg selenium (as sodium selenite) and 2.5mg cobalt (as cobalt sulphate).

TARGET SPECIES Cattle and sheep.

INDICATIONS FOR USE A broad spectrum multi-purpose anthelmintic for the control of mature and developing immature forms of gastrointestinal roundworms, lungworms, roundworm eggs.

In sheep it is active against benzimidazolesusceptible strains of the following species: Roundworms: Ostertagia, Haemonchus, Trichostrongylus, Nematodirus (including N. battus), Chabertia and Oesophagostomum. It is usually effective against inhibited larvae of Ostertagia.

Lungworms: Tapeworms: Moniezia spp.

Fasciola hepatica.

In cattle it is active against the following species: Roundworms: Ostertagia, Haemonchus, Trichostrongylus, Nematodirus, Oesophagostomum, Bunostomum, Cooperia and Strongyloides spp. It is usually effective against inhibited larvae of Cooperia and Ostertagia.

Lungworms: Dictyocaulus viviparus.

Tapeworms: Moniezia spp.

Adult Liver Fluke: Fasciola hepatica. roundworm eggs, contamination.

thus

reducing

pasture

CONTRAINDICATIONS Known hypersensitivity to the active ingredient.

SPECIAL WARNINGS FOR EACH TARGET SPECIES Cattle suffering from severe lung damage due to heavy lungworm infestation may continue to cough for some weeks after treatment.

Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy: Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.

Underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dosing device (if any).

Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

Resistance to benzimidazoles (which includes albendazole) has been reported in Cooperia, Haemonchus, Trichostrongylus, and Teladorsagia species in small ruminants in a number of countries, including the EU. Resistance to albendazole has been reported in Cooperia and Teladorsagia species in cattle in developed countries such as New Zealand. Therefore the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of

nematodes and recommendations on how to limit further selection for resistance to anthelmintics.

Fluke and worm dose: For the additional treatment of

SPECIAL PRECAUTIONS FOR USE

in cattle.

Dosage: 10 mg albendazole per bodyweight. (1ml/10kg body weight.)

i. SPECIAL PRECAUTIONS FOR USE IN ANIMALS Not to be diluted or mixed with other products.

Do not administer other cobalt and selenium advised by your veterinary surgeon.

Avoid the introduction of contamination during use.

The product should only be used in areas where occur. If in any doubt seek the advice of a veterinary surgeon.

Intensive use or misuse of anthelmintics can give rise to resistance. To reduce this risk, dosing programmes should be discussed with a veterinary surgeon.

Care must be taken not to damage the pharyngeal region when dosing, particularly in sheep. ii. SPECIAL PRECAUTIONS TO BE TAKEN

BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Avoid direct contact with the product. Wear suitable protective clothing including impermeable rubber gloves. thoroughly with running water.

If irritation persists, seek medical attention.

Wash hands after use.

ADVERSE REACTIONS SERIOUSNESS) None known

(FREQUENCY

AND

USE DURING PREGNANCY, LACTATION OR LAY The use of the product in breeding bulls or pregnant cattle is not expected to interfere with their reproductive performance.

(7.5 mg/kg), during tupping or for 1 month after removing the rams. Can be safely used during lactation.

INTERACTIONS WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS Administration of ionophores to lambs has been shown to enhance selenium bioavailability.

Concurrent administration of ionophores and the product may therefore lead to an increased risk of selenium toxicity.

AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTES: For oral administration only using properly calibrated dosing equipment.

To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked.

Shake the container before use.

kg

Sheep: Worm dose: For the control of roundworms, eggs.

Dosage: 5 mg albendazole per kg bodyweight.

(1ml/20kg body weight.)

Fluke and worm dose: For the additional in sheep.

Dosage: 7.5 mg albendazole per kg bodyweight.

(3ml/40kg body weight.)

Administration with a suitable drenching gun is recommended OVERDOSE Not applicable.

WITHDRAWAL PERIODS Animals intended for human consumption must not be slaughtered during treatment. Cattle must not be slaughtered for human consumption until 14 days after the last treatment. Sheep must not be slaughtered for human consumption until 4 days after the last treatment. Milk intended for human consumption may be taken from cows only after 60 hours from the last treatment. Not for use in sheep producing milk for human consumption.

INCOMPATIBILITIES None Known SHELF LIFE Shelf life of the veterinary medicinal product as packaged for sale: 18 months SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25째C. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT AND WASTE MATERIAL, IF ANY DANGEROUS to aquatic life. Do not contaminate ponds, waterways or ditches with the product or used containers. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

MARKETING AUTHORISATION HOLDER Cross Vetpharm Group Ltd. Broomhill Road, Tallaght, Dublin 24. Ireland MARKETING AUTHORISATION NUMBER VPA 10960/027/001 LEGAL CATEGORY:

LM

Cattle: Worm dose: For the control of roundworms,

PACKAGE QUANTITIES: 1, 2.5, 5 and 10 Litres

eggs.

Dosage: 7.5 mg albendazole per kg bodyweight.

(3ml/40kg body weight.)

A full product SPC is available on request from Bimeda or alternatively can be found on the IMB website

www.bimeda.ie www.bimeda.ie

73

PRODUCT PRODUCT INFORMATION

ENDOFLUKE 10% Triclabendazole 100mg/ml INDICATIONS For the treatment of adult, immature and early immature stages of liver fluke (Fasciola hepatica) susceptible to triclabendazole.

BENEFITS • Complete chronic and acute fluke control in both cattle and sheep • Low volume dose 6ml per 50kg, helps ensure accurate dosing of stock, easier and quicker.

• Tried and trusted Triclabendazole based fluke treatment • Kills, early-immature, mature and adult liver fluke

PACKAGING

Bimeda®® Bimeda Broomhill Broomhill Road Road Tallaght Tallaght Dublin 24, Ireland Dublin 24, Ireland Tel: 1850-515253 Fax: 01 451 5803 Tel: 1850-515253 74

LIST NO.

UNIT PACKAGE

1END023

2.5L

See reverse side for Administration and Dosage.

www.bimeda.ie www.bimeda.ie

TECHNICAL TECHNICAL INFORMATION INFORMATION

ENDOFLUKE 100 mg/ml ORAL SUSPENSION Triclabendazole 100mg/ml

PRESENTATION A white to off-white suspension for oral administration only. Each ml contains 100mg of triclabendazole, 2mg of methyl parahydroxybenzoate (E218) and 0.2 mg of propyl parahydroxybenzoate TARGET SPECIES Cattle & Sheep.

USE For the treatment of adult, immature and early immature triclabendazole.

CONTRAINDICATIONS Do not use in animals known to be hypersensitive to the active substance.

SPECIAL WARNINGS FOR EACH TARGET SPECIES Care should be taken to avoid the following practices, because they increase the risk of development of resistance and could ultimately result in ineffective therapy: - Too frequent and repeated use of anthelmintics from the same class, over an extended period of time - Under dosing, which may be due to underestimation of bodyweight, misadministration of the product or lack of calibration of the dosing device (if any).

Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. Faecal Egg Count Reduction Test). Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to another pharmacological class and having a different mode of action should be used.

Resistance to triclabendazole has been reported in Fasciola hepatica in cattle and sheep.Therefore, the use of this product should be based on local (regional/farm) epidemiological information about susceptibility of the Fasciola hepatica and recommendations on how to limit further selection for resistance to anthelmintics.

SPECIAL PRECAUTIONS FOR USE i) Special precautions for use in animals Care should be taken when dosing animals to avoid causing injury to the mouth and pharynx. ii) Special Precautions to be taken by the person administering the product to animals When using, do not eat, drink or smoke.

Wash splashes from eyes and skin immediately.

Take off immediately any contaminated clothing.

Wash hands and exposed skin before meals and after use. iii) Other precautions and aquatic invertebrates. Cattle and sheep must not have any access to the surface water such as streams, ponds or ditches within 7 days after treatment. When spreading manure from treated animals on arable lands, a safety distance of 10m to adjacent surface waters must be kept.

ADVERSE REACTIONS (frequency and seriousness) including the udder and the teats may occur after treatment in cattle exposed to intense sunshine.

USE DURING PREGNANCY, LACTATION OR LAY The product is safe for use during pregnancy and lactation. However, the product is not permitted for use in animals producing milk for human consumption, including pregnant animals intended to produce milk for human consumption.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS None known.

AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTES For single oral administration only using properly calibrated dosing equipment. The product is suitable for most types of automatic drenching guns.

Shake the container before use.

Use unaltered from original container.

Clean drenching equipment before and after use.

WITHDRAWAL PERIODS Cattle and sheep meat and offal: 56 days Cattle and sheep milk: Not permitted for use in animals producing milk for human consumption including pregnant animals intended to produce milk for human consumption.

SHELF LIFE Shelf life of the veterinary medicinal product as packaged for sale: 2 years

Dosage:

SPECIAL PRECAUTIONS FOR STORAGE Protect from frost.

suitable for most types of automatic drenching guns.

Nature and Contents of Immediate Packaging

The recommended dose rate is 12mg triclabendazole per kg bodyweight in cattle and 10mg triclabendazole per kg bodyweight in sheep.

backpack containers containing a white to off-white smooth suspension. The closures used for both pack sizes are 38 mm propylene standard caps with an induction heat seal liner. A 38 mm polypropylene spouted cap is also provided with each pack size for dispensing purposes.

To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked.

If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- or overdosing.

The timing for re-treatment should be based on epidemiological risk patterns and should be customised for each individual farm.

To avoid the potential for the accumulation of residues following repeat administration of the product; animals should not be treated with a frequency of less than 10 weeks.

OVERDOSE A single oral dose of 150-200 mg triclabendazole/kg of live bodyweight may lead to side effects such as unsteady gait, dullness and reduced appetite. These side effects are slight and last 1 to 5 days. An antidote is not known.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE MATERIAL DERIVED FROM THE USE OF SUCH PRODUCTS invertebrates. Any unused product or waste material must not enter surface water and should be disposed of in accordance with national requirements.

Marketing Authorisation Number VPA 10960/046/001 Legal Category

POM Package Quantities 2.5 litre & 1 litre A full product SPC is available on request from Bimeda or alternatively can be found on the IMB website

Practical Dosage Guide: Cattle: 6 ml per 50kg bodyweight Animal Weight 50kg 100kg 150kg 200kg 250kg 300kg 350kg 400kg For each additional 50kg

Dose of product 6ml 12ml 18ml 24ml 30ml 36ml 42ml 48ml 6ml

Dose per 2.5L Pack 416 208 138 104 83 69 59 52

Sheep: 1 ml per 10kg bodyweight Animal Weight 10kg 20kg 30kg 40kg 50kg 60kg For each additional 10kg

Dose of product 1ml 2ml 3ml 4ml 5ml 6ml 1ml

Dose per 2.5L Pack 2500 1250 833 625 500 416

www.bimeda.ie www.bimeda.ie

75

PRODUCT INFORMATION

EQUIBACTIN

Trimethoprim 66.7mg Sulfadiazine 333.3mg/g INDICATIONS Treatment of infections in horses caused by bacteria sensitive to the combination of trimethoprim and sulfadiazine, particularly: • Respiratory tract infections associated with Streptococcus spp. and Staphylococcus aureus;• Control and treatment of Anoplocephala (Tapeworm) • Gastrointestinal infections associated with E. coli; Urogenital infections associated with beta- haemolytic streptococci • Wound infections and open or drained abscesses associated with Streptococcus spp. and Staphylococcus aureus

BENEFITS • Palatable aniseed flavour • Single syringe pack, easy to administer • Treats a 600kg horse in a single syringe • Broad spectrum activity against respiratory, gastrointestinal, urogenital and wound infections in horses • Powerful antibiotic formula of sulfadiazine and trimethoprim

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

1EQU005

45G SYRINGE

48

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 76

www.bimeda.ie

TECHNICAL INFORMATION

EQUIBACTIN VET. (333 mg/g + 67 mg/g) ORAL PASTE FOR HORSES. Presentation

Oral paste in a white to almost white suspension, containing trimethoprim 66.7mg and sulfadiazine 333.3mg per gram.

Target Species Horses.

Indications for use, specifying the target species

Treatment of infections in horses caused by bacteria sensitive to the combination of trimethoprim and sulfadiazine, particularly: Respiratory tract infections associated with Streptococcus spp. and Staphylococcus aureus; Gastrointestinal infections associated with E. coli; Urogenital infections associated with beta-hemolytic streptococci; Wound infections and open or drained abscesses associated with Streptococcus spp. and Staphylococcus aureus.

Contraindications

Do not use in horses known to be hypersensitive to sulfonamides, with serious hepatic or renal insufficiency nor with blood dyscrasias, Do not use this product to treat abscesses without proper drainage.

Special precautions for use

Special precautions for use in animals To avoid under- or overdosing assess bodyweight and dosage as accurately as possible before dosing. Do not use the same syringe in more than one animal.

Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.

Special precautions to be taken by the person administering the veterinary medicinal product to animals People with known hypersensitivity to sulfonamides should avoid contact with the veterinary medicinal product.

In case of reaction of hypersensitivity after exposure (such as skin rash), seek medical advice and show the package leaflet or the label to the physician. In case of severe reactions (swelling of the face, lips or eyes), seek prompt medical attention and take the package leaflet with you.

Adverse reactions (frequency and seriousness) Decrease or loss of appetite can occur

in treated animals.Loose faeces and diarrhea may develop during treatment with the product. If such effects appear, discontinue treatment immediately and institute appropriate symptomatic measures.

Use during pregnancy and lactation

Laboratory studies in rats and mice have shown evidence of teratogenic effects.

The safety of the product has not been established during pregnancy. Use only according to the benefit/risk assessment by the responsible veterinarian.

Interaction with other medicinal products and other forms of interaction Potentiated sulfonamides used in conjunction with detomidine are known to be able to cause fatal arrhythmias in the horse.

Amounts to be administered and administration route

trimethoprim

sulfadiazine Administration route: Oral use.Posology: 5 mg trimethoprim and 25 mg sulfadiazine per kg body weight per day to a maximum of 5 days.

One syringe is intended for 600 kg bodyweight and each syringe is subdivided into 12 markings.

The equivalent of one marking is sufficient to treat 50 kg of bodyweight and the minimum body weight for treatment is 50 kg. Directions for use Horse weight should be accurately determined for the correct use of the paste. The calculated dose is provided by adjusting the ring on the plunger according to the body weight of the horse. The paste is administered orally by inserting the nozzle of the syringe through the interdental space and depositing the required amount of paste on the back of the tongue. The animal’s mouth should be free of any food.

Immediately after administration, elevate the head of the horse for a few seconds to ensure the dose is swallowed.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Not known.

Withdrawal period(s)

Meat and offal: 14 days Not permitted for use in mares producing milk for human consumption.

Pharmacodynamic properties

Both active substances produce a sequential double blockade of bacterial synthesis of folic acid. This results in a synergistic and bactericidal action inhibiting sequential steps in the synthesis of purines, which are required for DNA synthesis. The combination has a broad action against many Grampositive and Gram-negative bacteria such as staphylococci, streptococci and E.coli.

Pharmacokinetic particulars

After a single oral administration of 5 mg trimethoprim and 25 mg sulfadiazine per kg body weight to horses, the following parameters (mean ± sd) were observed: Food intake appeared to affect the pharmacokinetic profile as both Cmax (mg/ml)

Tmax (hour)

T1/2 el (hour)

2.35 ± 0.59

0.91 ± 0.32

2.74 ± 0.91

14.79 ± 3.47

1.90 ± 0.76

7.4 ± 1.8

trimethoprim and sulfadiazine have been absorbed more rapidly in fasted horses.

Excretion of both actives is chiefly by the kidneys, by both glomerular filtration, and tubular secretion. Urine concentrations of both trimethoprim and sulfadiazine are severalfold higher than blood concentrations. Neither trimethoprim nor sulfadiazine interferes with the excretion pattern of the other.

Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf-life after first opening the immediate packaging: 8 weeks.

Special precautions for storage Do not refrigerate or freeze.

Nature and composition of immediate packaging

Pre-filled multi-dose (LD) polyethylene syringe with adjustable screw ring closed with a (LD) polyethylene cap, packed in a cardboard box.

Each syringe contains 45 g paste.

LEGAL CATEGORY

POM

VPA 10816/004/001

www.bimeda.ie 77

PRODUCT INFORMATION

FLEE

FLEE Household Flea Spray INDICATIONS FLEE controls household dog and cat flea infestations.

It also controls egg-bound and immature stages of these fleas. It controls Dust mites and their integumentary material (skin debris). It indirectly controls Atopic Dermatitis. FLEE is Non-toxic and non-pesticidal

BENEFITS • Presentation; Pressurised aerosol container containing 400ml • Odourless • Colourless • Non allergenic • Completely safe • Non toxic

COMPOSITION Active Substance • Active ingredient; 0.4% Dimeticone gel/gum Also contains cyclometicone

TARGET SPECIES • Environmental Flea spray

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

1FLE004

400ML

12

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 78

www.bimeda.ie

TECHNICAL INFORMATION

FLEE

Flee Household Flea Spray FLEE When this is sprayed on a flea, it evaporates off after 20 minutes, leaving a gum/glue on the outer skin of the parasite. Staining on household surfaces is minimal and the ‘wet look’ usually fades once dry. FLEE does not feel sticky to touch. It is non-insecticidal and non-pesticidal. It is effective against adults, larvae, eggs and pupae.

As a result, adults and mobile larvae are ‘glued up’ (adults within 1 min, larvae in 10mins) and eventually die of starvation.

Eggs and Pupae are coated in sticky layer and continue to physically develop but cannot emerge from their chitin sac. FLEE also ‘Glues’ adult dust mites and their integumentary material (debris and faeces).

Due to its non-insecticidal mode of action, resistance is not an issue. The adhesive effects of FLEE persist for 6 days in deep carpet, immobilising all adults and larvae for 6 days after application. It is not orally toxic to pets. FLEE has very low toxic levels in general. It is not absorbed following oral/ dermal exposure. FLEE reduces dust mite allergens (Thornton & Ross). This product is effective for at least 6 weeks (reapply every 6 weeks at the most). Vacuuming is NOT required after application. You do not need to treat the whole house, merely the areas in contact with your Pet. DIRECTIONS FOR USE: Shake can well before use. Direct nozzle approximately 40 cm from the surface you want to treat and away from your body.

Using a sweeping motion to ensure uniform delivery, apply a 14 second spray per square metreon carpets, upholstered furniture and pet bedding. If spraying large areas shake can occasionally to maintain an even distribution of product. Wash your hands after use.

YOU DO NOT need to ventilate the room after application. Not orally toxic to pets.

Very low toxic levels in general. Not absorbed following oral/dermal exposure.

FLEE reduces dust mite allergens (Thornton & Ross). FLEE is effective for at least 6 weeks (re-apply every 6 weeks at the most).

Vacuuming is NOT required after application.

Does not need to treat whole house, merely areas in contact with Pet. DO NOT need to ventilate the room after application PRECAUTIONS: Keep away from food and drinks. Avoid eye contact. If your eyes are accidentally affected, flush with plenty of clean water.

Seek medical advice if irritation persists.

Due to the oily nature of the ingredients, some surfaces could be slightly slippery before they dry. Take necessary precautions if this is the case. FLEE can be used on most surfaces.However, before use on large surfaces or potentially delicate fabrics such as leather, we recommend that you test a small, out-of-sight area to check the suitability of the product with the material.

Special precautions for the disposal of unused veterinary medicinal product or waste material derived from the use of such products: Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Distributed in Ireland by Bimeda in partnership with Excella-tec, a division of Cross Vetpharm Group Ltd., Broomhill Road, Tallaght, Dublin 24, Ireland Distributed in UK by Bimeda in partnership with Excella-tec, Bryn Cefni Industrial Park, Llangefni, Anglesey, LL77 7XA, Wales

WARNINGS: Pressurised container: protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn even after use. Do not spray on or near a naked flame, electrical equipment or any incandescent material. Keep away from sources of ignition – No smoking. Keep can out of the reach and sight of children.

Use only as directed. Please recycle when empty. FLEE contains a patented combination of silicones. Due to their mechanical mode of action, these active ingredients are considered exempt under the Biocides Directive.

You may notice slightly darker shading on sprayed surfaces. This is normal and will disappear as the product dries off completely. Hard non-porous surfaces should not normally require application. If sprayed such surfaces will appear wet for approximately 30 minutes after treatment and may present a slip hazard until dry.

www.bimeda.ie 79

PRODUCT INFORMATION

HELODIP Potassium ions Magnesium ions Calcium ions INDICATIONS Reduces the incidence of mastitis in lactating cows and heifers. Also maintains the skin condition of the udder.

BENEFITS • 3:1 dilution for longer usage • Non iodine based teat dip • Food safe • Can be used as a teat dip, spray or cluster dip • A pre or post teat dip/spray

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

1HEL002

5L

CASE SIZE 4

1HEL001

20L

1

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 80

www.bimeda.ie

TECHNICAL INFORMATION

HELODIP

Presentation A clear to faintly opalescent yellow, slightly viscous, solution intended for dilution with water and topical administration to cattle. Helodip contains 3.1% w/v of Ammonium Lauryl Sulphate in a buffered preserved formulation.

Also contains 0.3% w/v Methylparahydroxybenzoic acid (sodium salt) as a preservative.

Uses To reduce the incidence of mastitis in lactating cows and heifers. Also, to maintain skin condition of the udder.

Pharmaceutical Precautions Keep out of reach and sight of children.

For external use only.

Used product in dipping cups should be discarded 24 hours after dilution.

Legal Category

LM

Package Quantities 5 and 20 Litre.

VPA 10959/9/1

Dosage and Administration Add 3 parts clean water to 1 part Helodip. Apply the solution on the teats by dipping cup or modern sprayer. Animals must be treated immediately after milking. Change solution and wash dipping cup regularly. Pre-milking dip to reduce mastitis transmission during milking.

Wash teat clean with water, dip teats and after 30 seconds dry off dip with paper towels and proceed with milking.

Contra-indications, Warnings, etc.

For animal treatment only.

Not to be used on animals known to be hypersensitive to the active ingredients.

Withdrawal Periods Meat and milk: Nil.

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PRODUCT INFORMATION

HYSPAN

Neomycin Sulphate INDICATIONS • Hyspan is indicated for the treatment of scour in calves; especically scours due to E coli and Salmonella spp • Hyspan Sachets are Formulated to combat infection, dehydration and electrolyte loss

BENEFITS • A comprehensive oral scour treatment in calves • Unique formulation to combat infection, loss of electrolytes and dehydration • Contains the powerful antibiotic Neomycin sulphate, also contains glucose and electrolytes • Excellent in the fight against scours caused by E-coli and salmonella • Readily dispersable in warm water for quick uptake by animal after administration

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

1HYS002

100g

20

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 82

www.bimeda.ie

TECHNICAL INFORMATION

HYSPAN 400 mg ORAL POWDER Neomycin Sulphate Presentation It is a white to off-white free-flowing powder for oral administration.

Each 100g sachet contains 400mg of Neomycin Sulphate.

Target Species Calves.

Indications for use, specifying the target species For the treatment of scour in calves mainly due to Escherichia coli and Salmonella.

Specially formulated to combat infection, dehydration and loss of electrolytes.

Contraindications Do not use in animals with known hypersensitivity to the active ingredients.

Special warnings for each target species Withdraw all milk and milk replacer from scouring animals.

Special precautions for use Special precautions for use in animals Withdraw all milk and milk replacer from scouring animals.

Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Amounts to be administered and administration route For oral administration.

For calves between 35-75kg, 5 sachets are required.

Administer the contents of 1 sachet

dispersed in 3 pints of warm water twice daily for 2 days and once on the third day. Start treatment as soon as possible after the start of diarrhoea. Discontinue treatment after 2 days if no response is observed and consult your veterinary surgeon. Do not extend treatment beyond the recommended time.

Withdrawal period(s) Animals intended for human consumption should not be slaughtered during treatment.

Animals intended for human consumption should not be slaughtered until 28 days after the last treatment.

Nature and contents of immediate packaging Foil laminate sachet containing 100g of product.

Special precautions for the disposal of unused veterinary medicinal product or waste materials Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste under National Waste Disposal Regulations.

VPA 10960/067/001

Pharmacodynamic properties Hyspan acts locally on the gastrointestinal tract.

Neomycin sulphate is an antibiotic which is poorly absorbed from the gut and is thus present in maximum concentration at the site of infection. The electrolytes restore electrolyte balance and relieve dehydration. Glucose monohydrate is an immediate source of energy which enhances the absorption of electrolytes and water thus speeding rehydration.

Shelf life Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.

Special precautions for storage Store below 25째C.

www.bimeda.ie 83

PRODUCT INFORMATION

KEFAMAST DC Anhydrous Cefalexin Dihydrostreptomycin INDICATIONS • For dairy cow treatment at drying off • For the treatment of subclinical mastiits infections present at drying off and to assist in preventing new infections during the dry cow period

BENEFITS • A long acting dry cow treatment combining a cephalosporin and an aminoglycoside giving broad spectrum antimicrobial activity • Short withdrawals milk 40 days + 60 hours, resulting in a faster return to milk tank • Reduces high SCC and significantly aids in the prevention of new infections during the dry period • Excellent when combined with Boviseal • A unique antibiotic combination which provides outstanding synergistic acivity against sub-clinical mastitis

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

1KEF002

120 SYRINGES

1

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 84

www.bimeda.ie

TECHNICAL INFORMATION

KEFAMAST DRY COW Anhydrous Cefalexin Dihydrostreptomycin Presentation A sterile intramammary injection.

Each 9g contains: Cefalexin (anhydrous) 500mg Dihydrostreptomycin 500mg (as Dihydrostreptomycin Sulphate) Uses For the treatment of sub-clinical mastitis infection present at drying off of cows and to assist in preventing new infections occurring during the dry period.

Dosage and Administration The contents of one injector should be infused into the teat canal of each quarter immediately after the last milking of the lactation.

Before infusion, the teat should be thoroughly cleaned and disinfected.

Care should be taken to avoid contamination of the injector nozzle after the protective cap has been removed.

Contra-indications, Warnings, etc.

For animal treatment only.

Do not use within 40 days of the estimated calving date.

Not to be used in animals known to be hypersensitive to any of the active ingredients. Not for use in lactating cows.

Operator Warnings Operators should avoid contact with this preparation as occasional skin allergy may occur. Penicillins and cephalosporins may cause hypersensitivity following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross

reactions to cephalosporins and vice versa.

Allergic reactions to these substances may occasionally be serious. Do not handle this product if you know that you are sensitised, or if you have been advised not to work with such preparations Handle this product with care to avoid exposure. If you develop symptoms such as a skin rash following exposure, seek medical advice and show this warning to the doctor. Swelling of the face, lips or eyes, or difficulty with breathing are more serious symptoms and require urgent medical attention.

Withholding Periods With cows milked twice daily, milk for human consumption may only be taken from 60 hours (five milkings) after calving. Foodstuffs for human consumption must not be taken during the treatment period.

If calving occurs within 40 days of treatment, milk for human consumption may only be taken from 40 days + 60 hours after treatment. Animals intended for human consumption may only be slaughtered from 28 days after the last treatment.

Pharmaceutical Precautions Do not store above 25째C. Keep out of reach and sight of children.

Legal Category

POM

Package Quantities 120 injectors VPA 10126/32/1

www.bimeda.ie 85

PRODUCT INFORMATION

KEFAMAST LC Cefalexin Dihydrostreptomycin INDICATIONS • Broad Spectrum Intramammary anti microbial tube • For the treatment of all the major mastitis causing pathogens that are susceptible to the combination of cephalexin and dihydrosteptomycin in lactating cows.

BENEFITS • Broad spectrum antimicrobial activity against all major mastitis pathogens • Excellent synergistic activity against acute and chronic mastitis • Unique formulation with 2 powerful antibiotics, Cefalexin and Dihydrostreptomycin

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

1KEF010

24

1

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 86

www.bimeda.ie

TECHNICAL INFORMATION

KEFAMAST LACTATING COW Presentation Intramammary infusion, lactating cow.

Each 9 g contains: Cefalexin (anhydrous) 500 mg Dihydrostreptomycin 500 mg (as Dihydrostreptomycin Sulphate) Uses For the treatment of mastitis caused by organisms susceptible to the combination of Cefalexin and Dihydrostreptomycin in lactating cows.

Dosage and Administration The contents of one injector should be infused into each affected quarter, via the teat canal, immediately after milking and at twelve hourly intervals for a total of up to 3 infusions.

Before the infusion is made, the teat should be thoroughly cleaned and disinfected. Care should be taken to avoid contamination of the injector nozzle after the cap has been removed.

Contra-indications, Warnings, etc.

For animal treatment only.

Not to be used in animals known to be hypersensitive to the active ingredients.

Operator Warnings Operators should avoid contact with this preparation as occasional skin allergy may occur.

Penicillins and cephalosporins may cause hypersensitivity following injection, inhalation, ingestion or skin contact.Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and

vice versa.

Allergic reactions to these substances may occasionally be serious.

Do not handle this product if you know that you are sensitized, or if you have been advised not to work with such preparations.

Handle this product with care to avoid exposure.

If you develop symptoms such as a skin rash following exposure, seek medical advice and show this warning to the doctor.

Swelling of the face, lips or eyes, or difficulty breathing are more serious symptoms and require urgent medical attention.

for pharmaceutical waste under national waste disposal regulations.

Legal Category

POM

Package Quantities Cartons of 24 syringes.

VPA 10126/33/1

Withdrawal Periods Milk for human consumption must not be taken from cows during treatment. With cows milked twice daily, milk for human consumption may only be taken from 96 hours (i.e. at the eighth milking) after the last treatment.

Animals should not be slaughtered for human consumption during treatment. Cows may be slaughtered for human consumption only after 7 days following the last treatment.

Pharmaceutical Precautions Keep out of reach and sight of children. Store below 25째C. This product does not contain a preservative.

Avoid the introduction of contamination during use. For single use only.

Unused product or waste material should be disposed of in accordance with current practice

www.bimeda.ie 87

PRODUCT INFORMATION

MULTIMAST DC Neomycin Sulphate Penethamate hydriodide Procaine benzylpenecillin INDICATIONS • For dairy cow treatment at drying off • Has a broad spectrum of anti-bacterial activity • Effective against all susceptible major mastitis bacteria including particular effect against Environmental mastitis causing bacteria like E coli and Streptococcus uberis • Prolonged Neomycin release combined with slow release of Penicillin gives potent broad spectrum of activity • Powerful action to reduce SCCs • Prevents new infections during the dry cow period

BENEFITS • Broad spectrum dry cow treatment • Long acting 50 days • Active against all major mastitis bacteria including Staphs, Streps and E-coli • Prolonged Neomycin protection, with powerful action to reduce SCC’s

Bimeda® Broomhill Road

PACKAGING LIST NO.

UNIT PACKAGE

CASE SIZE

1MUL004

120 SYRINGES

1

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 88

www.bimeda.ie

TECHNICAL INFORMATION

MULTIMAST DRY COW Neomycin Sulphate Penethamate hydriodide Procaine benzylpenecillin Presentation Single dose plastic syringe containing a smooth off-white oily suspension for intramammary administration to animals.

Each 4.5g intramammary suspension contains: Neomycin Sulphate 100mg Penethamate Hydriodide 100mg Procaine Benzylpenicillin 400mg in a slow release base.

Uses For routine use in cows at drying off, to treat existing intramammary infections and to assist in preventing new infections occurring during the dry period.

Dosage and Administration The contents of one syringe should be infused into each quarter via the teat canal immediately after the final milking of a lactation.

Before infusion, the teat should be thoroughly cleaned and disinfected and care should be taken to avoid contamination of the injector nozzle. Following infusion, it is advisable to use a teat dip or spray.

Contra-indications, Warnings, etc.

For animal treatment only.

Do not use in the lactating cow.

Do not use within 50 days prior to calving.

Do not use in animals with known hypersensitivity to the active ingredients.

Operator Warnings Penicillins and cephalosporins may cause sensitisation following injection, inhalation, ingestion or skin contact. Sensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.

1 Do not handle this product if you know that you are sensitised, or if you have been advised not to work with such preparations.

2 Handle this product with care to avoid exposure, taking all recommended precautions.

3 If you develop symptoms such as a skin rash following exposure, seek medical advice and show this warning to the doctor. Swelling of the face, lips or eyes, or difficulty with breathing are more serious symptoms and require urgent medical attention.

Pharmaceutical Precautions Keep out of reach and sight of children.

Do not store above 25ยบC Legal Category POM Package Quantities 120 x 4.5g injectors.

VPA 10959/8/1

Withdrawal Periods Milk for human consumption may only be taken after 96 hours post calving in cows with a dry period of more than 50 days.

Milk for human consumption may only be taken after 50 days plus 96 hours after the last treatment for cows with a dry period of 50 days or less.

Animals may not be slaughtered for human consumption until 28 days from the last treatment.

www.bimeda.ie 89

PRODUCT INFORMATION

NEFOTEK

Nefotek 100 mg/ml solution for injection INDICATIONS Cattle: Anti-inflammatory and analgesic treatment of diseases in the musculoskeletal system and the udder.

Pigs: Anti-inflammatory and antipyretic treatment of Mastitis Metritis Agalactia Syndrome and respiratory diseases.

Horses: Anti-inflammatory and analgesic treatment of diseases in the musculature, joints and the skeleton. Symptomatic analgesic treatment for colic.

Postoperative pain and swelling.

BENEFITS • • •

• •

•

Suitable for pigs, cattle and horses Wide range of indications Excellent analgesic, anti-inflammatory and anti-pyretic properties Short meat and no milk withdrawal periods Suitable for symptomatic colic treatment in horses Suitable for treatment of postoperative pain and swelling

Bimeda®

PACKAGING LIST NO.

UNIT PACKAGE

CASE SIZE

1000000

100ml

12

1000000

250ml

12

See reverse side for full indications, administration and dosage.

Broomhill Road Tallaght Dublin 24, Ireland Tel: 1850-515253 90

www.bimeda.ie

TECHNICAL INFORMATION

NEFOTEK 100 mg/ml solution for injection TARGET SPECIES Cattle, pigs and horses INDICATIONS Cattle: Anti-inflammatory and analgesic treatment of diseases in the musculoskeletal system and the udder.

Pigs: Anti-inflammatory and antipyretic treatment of Mastitis Metritis Agalactia Syndrome and respiratory diseases.

Horses: Anti-inflammatory and analgesic treatment of diseases in the musculature, joints and the skeleton. Symptomatic analgesic treatment for colic. Postoperative pain and swelling.

BENEFITS Suitable for pigs, cattle and horses. Wide range of indications. Excellent analgesic, anti-inflammatory and antipyretic properties Short meat and no milk withdrawal periods.

Suitable for symptomatic colic treatment in horses.

Suitable for treatment of postoperative pain and swelling.

PRESENTATION Clear solution for injection One ml contains: Active substance Ketoprofen 100 mg EXCIPIENTS Benzyl alcohol USES Cattle: Anti-inflammatory and analgesic treatment of diseases in the musculoskeletal system and the udder.

This can include - the supportive treatment of parturient paresis associated with calving; - reducing the pyrexia and distress associated with bacterial respiratory disease when used in conjunction with antimicrobial therapy as appropriate; - improving the recovery rate in acute clinical mastitis, including acute endotoxin mastitis, caused by gram negative micro-organisms, in conjunction with antimicrobial therapy.

- reducing oedema of the udder associated with calving.

Pigs: Anti-inflammatory and antipyretic treatment of Mastitis Metritis Agalactia Syndrome and respiratory diseases.

This can include; reducing the pyrexia and respiratory rate associated with bacterial or viral respiratory disease when used in conjunction with antimicrobial therapy as appropriate.

The supportive treatment of Mastitis Metritis Agalactia Syndrome in sows, in conjunction with antimicrobial therapy as appropriate Horses: Anti-inflammatory and analgesic treatment of diseases in the musculature, joints and

the skeleton This can include - Diseases affecting the osteoarticular and muscular-skeletal system associated with acute pain and inflammation: - Lameness of traumatic origin - Arthritis - Osteitis, spavin - Tendinitis, bursitis - Naviculitis - Laminitis - Myositis Symptomatic analgesic treatment for colic.

Postoperative pain and swelling.

DOSAGE AND ADMINISTRATION Cattle: 3 mg ketoprofen/kg b.w., equivalent to 3 ml of NEFOTEK /100 kg b.w. intravenously or intramuscularly once a day for 3 to 5 days.

Pigs: 3 mg ketoprofen/kg b.w., equivalent to 3 ml of NEFOTEK /100 kg b.w. intramuscularly once a day for 3 to 5 days.

Horses: 2.2 mg ketoprofen/kg b.w, equivalent to 1 ml of NEFOTEK /45 kg b.w. Intravenously once per day for 3 to 5 days. In the case of colic, treatment should not be repeated until a clinical re-examination has been carried out.

CONTRAINDICATIONS AND WARNINGS Do not use in severe renal failure.

Do not use in conditions with a tendency to increased bleeding. Do not use in case of known hypersensitivity to ketoprofen. In the absence of specific tolerance data for very young foals, foals less than 15 days old should not be treated. Avoid intra-arterial injection. Do not exceed the stated dose or duration of treatment.

Use with caution in dehydrated animals and animals with low blood pressure. In the case of colic a supplementary dose may only be given after a thorough clinical examination. Special precautions to be taken by the person administering the veterinary medicinal product to animals. Avoid splashes on the skin and eyes. Irrigate thoroughly with water should this occur.

ADVERSE REACTIONS (frequency and seriousness) Repeated intramuscular injections can cause temporary irritation. Due to its mechanism of action including inhibition of prostaglandin synthesis, ketoprofen can cause gastric and intestinal irritation or ulceration. Use during pregnancy, lactation or lay. Studies of the effect of ketoprofen in pregnant laboratory animals and cattle have not produced any evidence of adverse effects. The effect on pregnant mares or sows has not been established. Concurrent administration with other non-steroidal antiinflammatory drugs and steroids is to be avoided.

Ketoprofen can counteract the diuretic effect of

loop diuretics. Concurrent treatment with anticoagulants should be avoided because of the increased risk of haemorrhage.

WITHDRAWAL PERIODS Meat and offal: Cattle 4 days, pigs 4 days, horses 4 days, Milk: Zero days.

NOTE Ketoprofen, in common with other nonsteroidal anti-inflammatorys is not permitted by Racing Authorities of Great Britain and Ireland to be used at the time of racing. Ketoprofen or its conjugates can be detected in urine for up to 10 days after treatment (analytical sensitivity of 50ng/ml). An interval of 15 days from cessation of treatment should ensure that the drug is undetectable in most horses.

PHARMACEUTICAL INFORMATION AND PRECAUTIONS: Non-steroidal anti-inflammatory/antirheumatic agent (NSAID). The active component of NEFOTEK is ketoprofen, a substance belonging to the group non-steroidal anti-inflammatory drugs (NSAIDs).

Ketoprofen has anti-inflammatory, analgesic and antipyretic properties. Not all aspects of its mechanism of action are known. Effects are obtained partially by the inhibition of prostaglandin and leukotriene synthesis by ketoprofen, acting on cyclooxygenase and lipoxygenase respectively. The formation of bradykinin is also inhibited. Ketoprofen inhibits thrombocyte aggregation.

List of excipients L Arginine, Benzyl alcohol, Citric acid monohydrate, Water for injections In the absence of compatibility studies, NEFOTEK must not be mixed with other medicinal products. Shelf life of the veterinary medicinal product as packaged for sale: 1 year.

Shelf life after first opening the immediate packaging: 28 days. Special precautions for storage. Store below 25ยบC. Store in the original package. Protect from light.

6.5 Nature and composition of immediate packaging NEFOTEK is packaged in amber type II glass vials of 100 ml and 250 ml.

Any unused veterinary medicinal product or waste materials derived from such Veterinary Medicinal product should be disposed of in accordance with local requirements LEGAL CATEGORY:

POM

MARKETING AUTHORISATION HOLDER: Bimeda Chemicals Ltd., Broomhill Road, Tallaght, Dublin 24, Ireland.

MARKETING AUTHORISATION NUMBER: Vm:

www.bimeda.ie 91

PRODUCT INFORMATION

OSMODEX Iodine

INDICATIONS For the cleaning and disinfection of animal environments e.g. housing pens, transport trucks, handling equipment, utensils and contact materials.

BENEFITS • Department of agriculture approved product • Concentrated low volume usage rate • Can be sprayed, poured or used as a fog mist • Concentrated iodine based disinfectant in handy 5L container

PACKAGING

Bimeda® Broomhill Road

LIST NO.

UNIT PACKAGE

CASE SIZE

1OSM004

5L

4

1OSM005

25L

1

See reverse side for full indications, administration and dosage.

Tallaght Dublin 24, Ireland Tel: 1850-515253 92

www.bimeda.ie

TECHNICAL INFORMATION

OSMODEX Iodine Presentation A liquid foaming acid iodophordetergent disinfectant with a powerful bactericidal action.

It contains: Available iodine, Phosphoric Acid , Sulphuric Acid and I.M.S. Uses For the cleaning and disinfection of animal environment , e.g. housing pens, transport trucks, handling equipment, utensils and contact materials. After removal of heavy soiling, clean and disinfect by thoroughly wetting and soaking all accessible surfaces. Inaccessible spaces may be sterilised by fogging.

Directions for Use Osmodex is approved by the Minister of Agriculture, Food and Rural Development for use against specific organisms at the following rates: Foot and Mouth Disease Dilute 1 in 525 with water Fowl Pest (Newcastle Disease) Dilute 1 in 150 with water Tuberculosis Dilute 1 in 15 with water Swine Vesicular Disease: Dilute 1 in 400 with water Anthrax, Brucellosis, Contagious Bovine Pleuro-Pneumonia,

Glanders and organisms such as E. coli, Salmonella etc. and other Scheduled diseases.

Dilute 1 in 110 with water General Sanitising: When using in livestock housing remove all portable equipment, litter and manure. Apply at a rate of 50ml Osmodex to 16 litres of water, ensuring that all surfaces are covered. Allow the area to dry if possible before replacing the equipment etc. and restocking.

Wheels and Footbath To prevent the spread of the disease, dilute 1 in 110 with water and renew daily if heavily soiled.

mouth, then drink plenty of milk or water and seek immediate medical attention, showing the container. Do not mix with other chemicals, especially chlorine releasing bleaches as toxic gas will be evolved.

Keep away from aluminium and its alloys.

This material and its container must be disposed of in a safe manner.

Package Quantities 5 litre and 25 litre

Aerial Disinfection: When diluted 1 in 500 with water, Osmondex may be used through a mist generator in the presence of livestock.

Drinking Water System Used as a sanitising aid, dilute 1 part of Osmodex with 1,600 parts of water.

Precautions For Use: Keep out of reach of children.

Keep container tightly closed in a well ventilated place.

Causes burns. When using, wear suitable protective clothing and eye/face protection.

In case of contact with eyes, rinse immediately with plenty of water and seek immediate medical advice. If swallowed, wash out

www.bimeda.ie 93

PRODUCT INFORMATION PRODUCT

OXYCOMPLEX NS Oxytetracycline 100mg/ml as Oxytetracycline Hydrochloirde Flunixin 20mg/ml as Flunixin Meglumine

INDICATIONS For the control and treatment of infectious diseases of cattle caused by or associated with organisms sensitive to oxytetracycline, where concurrent analgesic, anti-inflammatory, anti-endotoxic or antipyretic therapy is desired.

The product is especially indicated for the treatment of respiratory disease (particularly that associated with Mannheimia and Pasteurella infection) and acute mastitis (in conjunction with appropriate intramammary therapy).

BENEFITS • A powerful combination product with a proven antibiotic and a potent anti inflammatory agent • Broad spectrum activity against Gram-negative and Gram-positive bacteria • Rapid response and dramatic results • For treatment of pneumonia,mastitis, metritis & gastroenteritis • For intravenous & intramuscular use • Excellent syringeability

PACKAGING

Bimeda®® Bimeda Broomhill Broomhill Road Road Tallaght Tallaght Dublin 24, Ireland Dublin 24, Ireland Tel: 1850-515253 Fax: 01 451 5803 Tel: 1850-515253 94

LIST NO.

UNIT PACKAGE

CASE SIZE

1OXY004

100ml

12

See reverse side for Administration and Dosage.

www.bimeda.ie www.bimeda.ie

TECHNICAL INFORMATION

OXYCOMPLEX NS Oxytetracycline hydrochloride Flunixin Meglumine PRESENTATION A clear yellow to amber aqueous solution for injection. Each ml contains 100mg Oxyteracycline (as oxytetracycline hydrochloride) and 20mg Flunixin ( as flunixin meglumine) TARGET SPECIES Cattle.

INDICATIONS FOR USE For the control and treatment of infectious diseases of cattle caused by or associated with organisms sensitive to oxytetracycline, where concurrent analgesic, anti-inflammatory, antiendotoxic or antipyretic therapy is desired.

The product is especially indicated for the treatment of respiratory disease (particularly that associated with Mannheimia and Pasteurella infection) and acute mastitis (in conjunction with appropriate intramammary therapy) CONTRAINDICATIONS Do not administer other NSAIDs concurrently or within 24 hours of each other.

Use is contra-indicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastro-intestinal ulceration or bleeding, where there is evidence of a blood dyscrasia or hypersensitivity to the product.

SPECIAL WARNINGS FOR EACH TARGET SPECIES Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs to produce an increase in non-bound pharmacologically active concentrations, which can lead to toxic effects.

Rapid intraveneous injection in cattle may occasionally cause cardiovascular collapse.

Use in any animal less than 6 weeks of age or in aged animals may involve additional risk.

If such use cannot be avoided animals may require a reduced dosage and careful clinical management.

Avoid use in any dehydrated, hypovolaemic or hypotensive animal as there is a potential risk of renal toxicity. It is preferable that flunixin is not administered to animals undergoing general anaesthesia until fully recovered.

Concurrent administration of methoxyflurane anaesthesia or other potentially nephrotoxic drugs should be avoided.

SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Do not exceed the stated dose or duration of treatment. ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals Avoid eye contact and direct contact with skin.

To avoid possible sensitisation reactions, avoid contact with skin. Gloves should be worn during application. Wash hands after use.

In case of accidental contact with eyes, rinse immediately with plenty of water and seek medical advice. The product may cause reactions in sensitive individuals. If you have known hypersensitivity for non-steroidal anti-inflammatory products, do not handle the product. Reactions may be serious. Avoid accidental self-injection.

ADVERSE REACTIONS Prolonged use of NSAIDs, including flunixin, may predispose or lead to gastrointestinal ulceration.

USE DURING PREGNANCY, LACTATION OR LAY Reports of teratogenicity, effects on breeding performance, or gestation lengths have not been noted following use of flunixin.

Use with care in pregnant animals. The use of tetracyclines during the period of tooth development, including late pregnancy, may lead to tooth discolouration.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS The product may potentiate the effects of Warfarin and related drugs. Because of their common mode of action, flunixin may potentiate and be potentiated by other NSAIDs which act by interfering with prostaglandin synthesis.

AMOUNTS TO BE ADMINISTERED AND ADMINISTRATION ROUTE 1 ml per 10 kg bodyweight (equivalent to 10 mg oxytetracycline and 2 mg flunixin per kg bodyweight) daily for up to 5 days. The first injection should be administered intravenously, slowly, with subsequent injections given intramuscularly. Do not inject more than 20 ml intramuscularly at a single site. Where the dose exceeds 20 ml it should be divided between two or more sites, as appropriate.

OVERDOSE

Overdosing by intramuscular injection may give rise to swellings at the site of injection. Treatment should be symptomatic.

WITHDRAWAL PERIODS Meat: Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after 28 days following the last treatment.

Milk: Do not use in cattle producing milk for human consumption.

INCOMPATIBILITIES None.

SHELF LIFE (a) Shelf-Life – of the veterinary medicinal product as packaged for sale: 2 years (b) Shelf-Life - after first opening the immediate packaging: 28 days SPECIAL PRECAUTIONS FOR STORAGE Do not store above 25°C. Protect from light.

Following withdrawal of the first dose, use the product within 28 days. Discard unused material.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE MATERIALS, IF ANY Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

MARKETING AUTHORISATION HOLDER Cross Vetpharm Group Limited, Broomhill Road, Tallaght, Dublin 24, Ireland MARKETING AUTHORISATION NUMBER VPA 10126/063/001 LEGAL CATEGORY POM PACKAGE QUANTITIES 100ML MULTIDOSE VIALS A full product SPC is available on request from Bimeda or alternatively can be found on the IMB website

www.bimeda.ie 95

PRODUCT INFORMATION

OXYTOCIN Pro Injection INDICATIONS • Hormone Indicated for Cattle, Horses, Pigs, Sheep, Goats, Dogs and Cats • Uterine inertia, retention of the placenta, agalactia, prevention of haemorrhages after caesarian section or after hard delivery

BENEFITS • Oxytocin hormone for injection to a wide range of animals • IM administration route • For induced parturition, aid to parturition, stimulate involution of the uterus and stimulate milk let down • No withdrawal periods • Quick acting

PACKAGING LIST NO.

UNIT PACKAGE

CASE SIZE

1OXY037

50ml

12

See reverse side for full indications, administration and dosage.

Bimeda® Broomhill Road Tallaght Dublin 24, Ireland Tel: 1850-515253 96

www.bimeda.ie

TECHNICAL INFORMATION

OXYTOCIN Pro Injection CONTENTS:

50 ml Composition: Per ml solution for injection: Active substance: Oxytocin Ph. Eur. 10 I.U. Excipient (preservative): Chlorobutanol Hemihydrate Ph. Eur. 4.75 mg

Target species:

Cattle, pigs, horses, sheep, goats, dogs and cats.

Use

Uterine inertia, retention of the placenta, agalactia, prevention of haemorrhages after caesarean section or hard delivery.

Dosage and administration: For intramuscular or intravenous injection.

In mares by slow intravenous infusion (over 1 hour).

Obstetrics:

Cow: 20-50 I.U. per animal by intramuscular injection.

Sow: 10-40 I.U. per animal by intramuscular injection.

Mare: 20-50 I.U. per animal by intramuscular injection 40-50 I.U. per animal by slow intravenous infusion (over 1 hr) Ewe: 5-30 I.U. per animal by intramuscular injection.

Goat: 5-15 I.U. per animal by intramuscular injection.

Bitch: 0.5- 3 I.U. per animal depending on bodyweight by intramuscular injection. (administration during delivery).

0.3- 2 I.U. intravenous or 1-10 I.U. by intramuscular injection. (administration post partum).

Queen: 0.3- 1 I.U. per animal depending on bodyweight by intramuscular injection. (administration during delivery).

0.15- 1 I.U. intravenous or 1-3 I.U. by intramuscular injection. (administration post partum).

The quoted doses are guideline figures only and should in each case be adjusted according to the response of the animals.

During or shortly after delivery the minimum dose should be administered in all large animal species; this dosage can be repeated after approximately 30 minutes. The maximum dose should be administered when several hours have past sincedelivery.

Milk letdown:

Cow and mare: 10-40 I.U. Ewe, goat and sow: 5-20 I.U. Queen and bitch: 1-10 I.U. Contra-indications: Do not use oxytocin in case of incomplete dilation of the cervix, any form of obstructive dystocia, known cases of hypersensitivity to the active ingredient.

Side-effects: Hypersensitivity reactions sometimes occur.

Withdrawal period: Meat: 0 days Milk: 0 days

during use. Should any apparent growth or discoloration occur, the product should be discarded. Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste under national waste disposal regulations. Avoid skin contact with the solution.

Keep out of reach of children.

For animal treatment only.

LEGAL CATEGORY

POM

VPA 10989/44/1

Storage conditions:

Store between 2 - 8°C, do not freeze.

Shelf life

In-use shelf life is 28 days.

Precautions and warnings:

Oxytocin should not be given simultaneously by more then one route of administration. When oxytocin is administered in excessive dosage, hyperstimulation of the uterus with strong (hypertonic) and/or prolonged (tetanic) contractions, or an increased uterine tone between the contractions may occur, possibly resulting in uterine rupture, cervical and vaginal lacerations,postpartum haemorrhage, placental separation, impaired uterine blood flow, amniotic fluid embolism and foetal trauma including intracranial haemorrhage. Excessive doses of oxytocin may delay parturition by producing uncoordinated uterine contractions, which interfere with the progress of the foetus especially in multiple pregnancies. When oxytocin is used as an aid to parturition, cervical dilation must be confirmed prior to administration to prevent the risk of foetal death and possible uterine rupture. If uterine hyperactivity occurs, oxytocin administration should be immediately discontinued. Adrenaline at physiological levels markedly reduces the effect of oxytocin on the uterus or mammary gland.

For this reason the animal should not be frightened when complete oxytocin effect is desired to cause either milk “letdown” or uterine contractions.

Avoid the introduction of contamination

www.bimeda.ie 97

PRODUCT INFORMATION

RAPIDEXON

Dexamethasone INDICATIONS

In cattle, pigs, dogs and cats, dexamethasone may be used for the treatment of inflammatory or allergic conditions.

In cattle it can be used for treatment of primary ketosis (acetonaemia), induction of parturition.

In horses it can for treatment of arthritis, bursitis or tenosynovitis. Also for the treatment of inflammatory or allergic conditions.

BENEFITS • Rapid action, highly effective • Multiple indications • Short withdrawal periods • Contains sodium phosphate ester of dexamethazone which is water soluble and ensures fast intake and intense effect

PACKAGING LIST NO.

UNIT PACKAGE

CASE SIZE

1RAP001

100ml

12

See reverse side for full indications, administration and dosage.

Bimeda® Broomhill Road Tallaght Dublin 24, Ireland Tel: 1850-515253 98

www.bimeda.ie

TECHNICAL INFORMATION

RAPIDEXON 2 mg/ml SOLUTION FOR INJECTION Presentation

A clear colourless solution practically free from particles. Each ml contains: Dexamethasone (as Dexamethasone Sodium Phosphate) 2.0 mg

Target Species Horses, cattle, pigs, cats and dogs.

Uses

In horses, cattle, pigs, dogs and cats: Dexamethasone may be used for the treatment of inflammatory or allergic conditions. In cattle: Treatment of primary ketosis (acetonaemia). Induction of parturition. In horses: Treatment of arthritis, bursitis or tenosynovitis.

Contraindications, warnings etc.

Except in emergency situations, do not use in animals suffering from diabetes mellitus, renal insufficiency, cardiac insufficiency, hyperadrenocorticism or osteoporosis.

Do not use in viral infections during the viraemic stage or in cases of systemic mycotic infections. Do not use in animals suffering from gastrointestinal or corneal ulcers, or demodicosis.

Do not administer intra-articularly where there is evidence of fractures, bacterial joint infections and aseptic bone necrosis. Do not use in known cases of hypersensitivity to the active substance, to corticosteroids and to any other ingredient of the product. If the veterinary medicinal product is used for induction of parturition in cattle, then a high incidence of retained placentae may be experienced and possible subsequent metritis and/or subfertility.

Administration in early pregnancy is known to have caused foetal abnormalities in laboratory animals.

Administration in late pregnancy is likely to cause abortion or early parturition in ruminants and may have a similar effect in other species. Use of the veterinary medicinal product in lactating cows may cause a reduction in milk yield.

Response to long-term therapy should be monitored at regular intervals by a veterinary surgeon.

Use of corticosteroids in horses has been reported to induce laminitis.

Therefore horses treated with such preparations should be monitored frequently during the treatment period.

Because of the pharmacological properties of the active ingredient, special care should be taken when the product is used in animals with a weakened immune system. Following intra-articular administration, use of the joint should be minimized for one month and surgery on the joint should not be performed within eight weeks of use of this route of administration. Only the 25 ml vial should be used to treat cats, dogs and small piglets to prevent excessive puncturing of the closure.

Dosage and Administration

Horses, cattle, pigs 0.06 mg/kg body weight corresponding to 1.5 ml/50 kg Dog, cat 0.1 mg/kg body weight corresponding to 0.5 ml/10 kg For intravenous, intramuscular, intraarticular intrabursal or local administration in horses. For intramuscular injection in cattle, pigs, dogs and cats.

Doses may be repeated once at 24-48 hour intervals if required.

Injection sites should be alternated.

Care should be taken not to overdose Channel Island breeds. Larger doses will be required if the signs have been present for some time or if relapsed animals are being treated. For the induction of parturition - 0.04 mg/kg body weight corresponding to 10 ml per cow as a single intramuscular injection after day 270 of pregnancy.

Parturition will normally occur within 48-72 hours. If calving does not occur within these periods the dose may be repeated.

For the treatment of arthritis, bursitis or tenosynovitis by single intra-articular, intrabursal or local injection in the horse: Dosage 1-5 ml. Injections into joint spaces or bursae should be preceded by the removal of an equivalent volume of synovial fluid. Strict asepsis is essential.

Operator Warnings

In case of accidental self-injection, seek medical advice immediately and show the package leaflet to the physician.

People with known hypersensitivity to the active substance or any of the excipients should avoid contact with the veterinary medicinal product.

Pregnant women should not handle this veterinary medicinal product.

Adverse reactions

Corticosteroids are known to exert a wide range of side-effects. Whilst single high doses are generally well tolerated, they may induce severe adverse reactions with long term use and when esters possessing a long duration of action are administered.

Dosage in medium to long term use should therefore generally be kept to the minimum necessary to control clinical signs.

Incompatibilities

In the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Overdose

An overdose can induce drowsiness and lethargy in horses.

Withdrawal Period(s) Cattle meat and offal: 7 days milk: 72 hours Pig meat and offal: 2 days Horse meat and offal: 11 days.

Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale in 50 ml and 100 ml vials: 24 months.

Shelf-life of the veterinary medicinal product as packaged for sale in 25 ml vials: 18 months.

Shelf-life after first opening the immediate packaging: 28 days.

Special precautions for storage

Do not store above 25째C. Do not freeze.

Keep vial in the outer carton.

Disposal

Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Packaging

100ml glass Type I vial

LEGAL CATEGORY POM VPA 10989/056/001

www.bimeda.ie 99

PRODUCT INFORMATION

SEDAXYLAN Xylazine

INDICATIONS • Sedation of dogs, cats, horses and cattle

BENEFITS • Highly effective and well tolerated • Clinical trial results indicate Sedaxylan is effective in all target species • Effective on the CNS in 10-15 minutes after administration by IM, and 3-5 minutes after IV • Low administration rate • Nil milk withdrawal

PACKAGING LIST NO.

UNIT PACKAGE

CASE SIZE

1SED003

25ml

12

See reverse side for full indications, administration and dosage.

Bimeda® Broomhill Road Tallaght Dublin 24, Ireland Tel: 1850-515253 100

www.bimeda.ie

TECHNICAL INFORMATION

Sedaxylan 20 mg/ml Presentation

Clear and colourless solution for injection.

Each ml contains: Xylazine (base) 20.0 mg Equivalent to 23.32 mg xylazine hydrochloride

Target Species

Dogs, cats, horses and cattle.

Contraindications, warnings etc.

Horses: Xylazine inhibits the normal intestinal motility. Therefore, it should only be used in horses with colic, that are not responsive to analgesics. The use of xylazine should be avoided in horses with caecal malfunction. After treatment of horses with xylazine, the animals are reluctant to walk. So whenever possible the drug should be administered in the place where the treatment/investigation is going to take place. Caution should be taken in the administration of the product to horses susceptible to laminitis. Horses with air way disease or malfunction may develop life-threatening dyspnoea. Cats and dogs: Xylazine inhibits the normal intestinal motility. This may make xylazine sedation undesirable for upper gastrointestinal radiographs, because it promotes filling of the stomach with gas and makes interpretation less certain.

Brachycephalic dogs with air way disease or malfunction may develop life-threatening dyspnoea. Cattle: Ruminants are highly susceptible to the effects of xylazine. Normally cattle remain standing at the lower doses, but some animals may lie down. At the highest recommended doses most animals will lie down and some animals may relapse in lateral recumbency.

Reticulo-ruminal motor functions are depressed after injection of xylazine. It is advisable to withhold feed and water for several hours before administration of xylazine. In cattle the ability to eructate, cough and swallow is reduced during the period of sedation, therefore cattle must be closely watched during the recovery period: the animals should be maintained in sternal recumbency. In cattle life threatening effects may occur after intramuscular doses above 0.5 mg/kg body weight (respiratory and circulatory failure). Therefore very precise dosing is required. In case of dehydration, xylazine should be used cautiously.

Emesis is generally seen within 3-5 minutes after xylazine administration in cats and dogs. It is advisable to fast dogs and cats for 12 hours prior to surgery; they may have free access to drinking water. Do not exceed the recommended

dosage. Following administration animals should be allowed to rest quietly until the full effect has been reached. It is advised to cool animals when the ambient temperature is above 25°C and to keep animals warm at low temperatures.

In painful procedures xylazine should always be used in combination with a local or general analgesic. Xylazine produces a certain degree of ataxia.

Therefore, xylazine must be used cautiously in procedures involving the distal extremities and in standing castrations in the horse. Treated animals should be monitored until the effect has faded totally (e.g. cardiac and respiratory function, also in the post-operative phase). Do not use in the later stages of pregnancy (particularly in cattle and cats), because xylazine causes uterine contractions and it may induce premature labour. Do not use in cattle receiving ovum transplants as the increased uterine tone may reduce the chance of implantation of the ovum.

Dosage and Administration

This product is intended for single intravenous, intramuscular or subcutaneous injection dependent upon the species in which it is to be used.

First effects are usually seen within 2 minutes following intravenous injection and within 5 to 10 minutes after intramuscular or subcutaneous injection.

The maximum effect is seen 10 minutes later. Accurately ascertain the body weight of an animal before treatment with xylazine Dogs: 1.0 - 2.0 mg per kg body weight intramuscularly or subcutaneously 0.5 – 1.0 ml injection solution/10 kg body weight IM or SC 0.7 - 1.0 mg per kg body weight intravenously.

0.35 – 0.5 ml injection solution/10 kg body weight IV Cats: 0.5 - 1.0 mg per kg body weight intramuscularly or subcutaneously.

0.125 – 0.25 ml injection solution/ 5 kg body weight IM or SC Horses: 0.5 - 1.0 mg per kg body weight intravenously.

2.5 – 5.0 ml injection solution/100 kg body weight IV Cattle: 0.05 – 0.20 mg per kg body weight intramuscularly or 0.25 – 1.0 ml injection solution/100 kg body weight IM 0.03 – 0.10 mg per kg body weight intravenously.

0.15 – 0.5 ml injection solution/100 kg body weight IV

Operator Warnings

In the case of accidental oral intake

or self-injection, seek medical advice immediately and show the package insert to the physician.

DO NOT DRIVE as sedation and changes in blood pressure may occur.

Avoid skin contact and wear impermeable gloves when handling the product. Wash the exposed skin immediately after exposure with large amounts of water. In the case of accidental projection of the product into the eyes, rinse abundantly with fresh water. If irritation persists, seek the advice of a physician. Pregnant women should not handle the product.

Overdose

In the event of an accidental overdose, cardiac arrhythmias, hypotension, and profound CNS and respiratory depression may occur. Seizures have also been reported after an overdose. Xylazine can be antagonized by α2-adrenergic antagonists: atipamezole has been found to be a useful antidote in some cases.

The recommended dosage is: 0.2 mg/kg for dogs and cats, 0.15 mg/kg for horses and 0.03 mg/kg for cattle.

To treat the respiratory depressant effects of xylazine, mechanical respiratory support with or without respiratory stimulants (e.g. doxapram) can be recommended.

Withdrawal Period(s) Horse (meat) - One day.

Cattle (meat) - One day.

Cattle (milk) - Zero days.

Incompatibilities

Sedaxylan should not be mixed with other medicinal products.

Shelf-life Shelf-life of the veterinary medicinal product as packaged for sale: 36 months. Shelf-life after first opening the container: 28 days.

Special precautions for storage This veterinary medicinal product does not require any special storage conditions.

Disposal

Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Packaging

25ml Type II glass vials

LEGAL CATEGORY

POM

VPA 10989/50/1

www.bimeda.ie 101

PRODUCT INFORMATION

SELECTAN Florfenicol

INDICATIONS Diseases caused by florfenicol susceptible bacteria: Cattle: Therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.

Swine: Treatment of acute outbreaks of respiratory disease caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida.

BENEFITS • A single product for 2 species- swine & cattle • Excellent syringeability allowing product to be injected quicker, more animals treated in less time and causes less stress • 250ml plastic bottle for ease of handling and prevention of breakages • For the treatment of acute outbreaks of respiratory disease • IM route of administration

PACKAGING LIST NO.

UNIT PACKAGE

CASE SIZE

1SEL001

100ml

12

See reverse side for full indications, administration and dosage.

Bimeda® Broomhill Road Tallaght Dublin 24, Ireland Tel: 1850-515253 102

www.bimeda.ie

TECHNICAL INFORMATION

SELECTAN Presentation

A slightly yellowish and clear solution for injection. Each ml contains 300mg of florfenical.

Target Species Cattle and swine.

Use

Diseases caused by florfenicol susceptible bacteria: Cattle: Therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.

Swine: Treatment of acute outbreaks of respiratory disease caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida.

Contra-indications, Warnings, etc.

Do not administer to adult bulls or boars intented for breeding purposes. Do not administer to cattle producing milk for human consumption. Do not administer to animals with known hypersensitivity to the active substance or to any of the excipients

Special precautions for use In animals

Use of the veterinary medicinal product should be based on susceptibility testing and take into account official and local antimicrobial policies. Do not use in piglets of less than 2 kg. Swab the septum before removing each dose. Use a dry, sterile syringe and needle Special precaution to be taken by the person administering the medicinal product to animals Care should be taken to avoid accidental self-injection.

Avoid contact with eyes and skin.

If eye exposure occurs, flush eyes immediately with clean water.

If skin exposure occurs, wash the affected area with clean water.

Wash hands after use.

People with known hypersensitivity to florfenicol, propylene glycol or polyethylene glycol should avoid contact with the veterinary medicinal product.

Adverse reactions (frequency and seriousness)

Cattle A decrease in food consumption and transient softening of the faeces may occur during the treatment period. The treated animals recover quickly and completely upon termination of treatment.

Administration of the veterinary medicinal product may cause inflammatory lesions at injection site which persist for up to 14 days. Swine Commonly observed adverse

effects are transient diarrhoea and/or peri-anal and rectal erythema/oedema which may affect 50% of the animals.

These effects can be observed for one week.Transient swelling lasting up to 5 days may be observed at the site of injection. Inflammatory lesions at the injection site may be seen for up to 28 days.

Use during pregnancy, lactation or lay

Studies in laboratory species have not produced any evidence of teratogenic or foetotoxic effects. Safety during pregnancy and lactation has not been investigated in the target species.

Use only accordingly to the benefit/ risk assessment by the responsible veterinarian

Amounts to be administered and administration route

Cattle: 20 mg/kg bodyweight (1 ml of SELECTAN per 15 kg) by intramuscular route to be administered twice 48 hours apart.

The volume administered per injection site should not exceed 10 ml.

Swine: 15 mg/kg bodyweight (1 ml of SELECTAN per 20 kg) by intramuscular injection into the neck muscle twice at 48 hours intervals. The volume administered per injection site should not exceed 3 ml.

Overdose (symptoms, emergency procedures, antidotes), if necessary

In swine, after administration of 3 times the recommended dose or more a reduction in feeding, hydration and weight gain has been observed. After administration of 5 times the recommended dose or more vomiting has also been noted.

Withdrawal Period(s)

Cattle: Meat and offal: 30 days.

Not permitted for use in lactating animals producing milk for human consumption.

Swine: Meat and offal: 18 days .

Pharmacokinetic properties

Cattle: In cattle, intramuscular administration at the recommended dose of 20 mg/kg maintains efficacious blood levels for 48 hours. Maximum mean serum concentration (Cmax) of 2.55 μg/ml occurs at 4.7 hours (Tmax) after dosing.

The mean serum concentration 24 hours after dosing was 1.4 μg/ml. The harmonic mean elimination half-life was 26.2 hours.

Pigs: After initial intramuscular administration of florfenicol, maximum serum concentrations of between 1.9 and 3.1 μg/ml are reached after 2.2 hours and the concentrations deplete with a terminal mean half-life of 35.5 hours. After a second intramuscular administration, maximum serum concentrations of between 2.0 and 8.1 μg/ml are reached after 1.7 hours.

Florfenicol concentrations achieved in lung tissue reflect plasma concentrations, with a lung:plasma concentration ratio of approximately 1. After administration to pigs by intramuscular route, florfenicol is rapidly excreted, primarily in urine. The florfenicol is extensively metabolised.

List of excipients N-methylpyrrolidone.

Glycerol formal.

Shelf-life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf-life after first opening the immediate packaging: 28 days.

Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

Nature and composition of immediate packaging

The veterinary medicinal product is bottled in 100 ml colourless Type II glass bottles and 250 ml plastic bottles, closed with Type I polymeric elastomer stopper with aluminium cap. One bottle of 100 ml or one bottle of 250 ml is available in a cardboard box. Also clinical pack sizes are available: 10 x 100, 10 x 250, 12 x 100, and 12 x 250. Not all pack sizes may be marketed.

Special precautions for the disposal of unused veterinary medicinal products or waste materials

Any unused veterinary medicinal product or waste material should be disposed of in accordance with national requirements.

LEGAL CATEGORY

POM

VPA 10846/008/001

www.bimeda.ie 103

PRODUCT INFORMATION

SULPHADIMIDINE PDR Sulphadimidine Sodium INDICATIONS For the treatment of infections caused by microorganisms (both bacterial and coccidian) susceptible to Sulphadimidine.

BENEFITS • Antibiotic powder for use in treating infections in calves, poultry and cattle • Particularly effective against coccidiosis • Broad spectrum activity of Sulphadimadine Sodium 100% • Short withdrawals: milk 5 days, meat 21 days • Readily soluble in water

PACKAGING LIST NO.

UNIT PACKAGE

CASE SIZE

1SUL003

25g Sachet

200

See reverse side for full indications, administration and dosage.

Bimeda® Broomhill Road Tallaght Dublin 24, Ireland Tel: 1850-515253 104

www.bimeda.ie

TECHNICAL INFORMATION

SULPHADIMIDINE SODIUM POWDER FOR ORAL SOLUTION Presentation A white or creamy white odourless powder. Sulphadimidine Sodium 1000 mg.

Target Species Cattle and poultry.

Uses For the treatment of infections caused by micro-organisms (both bacteria and Coccidia) susceptible to Sulphadimidine.

Contraindications, warnings etc.

Do not use in animals with serious liver and renal disturbances or in animals with diseases accompanied with a decreased intake of fluids or a decreased urine production or in cases of aciduria.

Do not use in animals with damage to the haematopoietic system.

Do not administer to laying hens.

Do not use in case of hypersensitivity to the active ingredient.

After administration of this product to ruminants, sometimes a temporary interference with ruminal function and microfloral activity may occur.

However, spontaneous recovery is likely.

Monitor water intake in poultry and calves during treatment.

Operator Warnings Avoid skin contact with the powder and avoid inhalation of the dust. pronounced in cases of decreased diuresis).

Use during pregnancy, lactation or lay The safety of the veterinary medicinal product has not been established during pregnancy, lactation or lay.

Use only accordingly to the benefit/ risk assessment by the responsible veterinarian.

Interaction with other medicinal products Simultaneous administration with para-aminobenzoic acid, its esters (e.g. procaine, tetracaine) and methenamine must be avoided.

Doses and Administration For oral administration via the drinking water.

Calves: 100 mg per kg bodyweight.

Dosage interval: 12-24 hours.

Duration: 3-5 days.

Poultry (non laying hens and broilers): 100 mg per kg bodyweight (1 g powder per 1 – 2 litres drinking water, depending on actual water intake) Acute Coccidiosis: Administration during 3 consecutive days; after 2 days of no treatment, another 3 day treatment.

Subclinical Coccidiosis: Administration for 3 consecutive days.

Overdose Acute overdose: Following an overdose a clear drop in water intake will occur in poultry.

Administration to calves via the artificialmilk may lead to a retarded uptake of water and to diarrhoea.

Chronic overdose: Haemorrhagic symptoms have been reported after long term administration of sulphonamides. A certain degree of immunosupression may occur making the animals more susceptible to secondary bacterial infections (especially gangrenous dermatitis in poultry). All undesirable effects documented under 4.6 may also occur following chronic overdosing.

Withdrawal Period(s) Poultry: Meat & offal: 14 days.

Do not administer to laying hens.

Cattle: Meat & offal: 21 days Milk: 5 days (i.e. 11th milking) Shelf-life Shelf-life of the veterinary medicinal product as packaged for sale: 2 years Shelf-life after dilution or reconstitution according to directions: 24 hours Storage Do not store above 25°C. Protect from light.

Packaging LDPE bags of 1kg, 5kg, 10kg, 25 kg and 50kg. Sealed 4 layer sachet (clay-coated paper/polyethylene/ aluminium foil/ionised) of 25g. Not all pack sizes may be marketed Disposal Any unused product or waste material should be disposed of in accordance with national requirements.

LEGAL CATEGORY POM Packaging 200 x 25 sachets VPA 10989/50/1

www.bimeda.ie 105

PRODUCT INFORMATION

TETROXY LA Oxytetracycline INDICATIONS • Indicated for cattle, sheep and pigs • Tetroxy LA is licenced for the treatment and control of disease processes where oxy tetracycline suspectible bacteria are involved.

• Tetroxy LA is a Long Acting Injection, one injection giving three days antibiotic cover • If necessary the long acting treatment should be repeated after 72 hours

BENEFITS • Convenience, one treatment usually sufficient, reduces labor and number of injection sites • Broad spectrum activity of oxytetracycline • Minimal irritancy-well tolerated in cattle, sheep and pigs • Ease of administration- 1ml/10kg with excellent syringeability • Rapid initial blood levels followed by a long acting effect • Ready to use, no mixing or refrigeration • High syringability, injects well even at cold temperatures

PACKAGING LIST NO.

UNIT PACKAGE

CASE SIZE

1TET015

100ml

12

See reverse side for full indications, administration and dosage.

Bimeda® Broomhill Road Tallaght Dublin 24, Ireland Tel: 1850-515253 106

www.bimeda.ie

TECHNICAL INFORMATION

TETROXY LA Presentation A long acting oxytetracycline injectable solution.

Each ml contains: 200mg oxytetracycline (as Oxytetracycline Dihydrate). This product does not contain an antimicrobial preservative Also contains Povidone and NMP as co-solvents and Sodium Formaldehyhe Sulfoxylate 0.27% as an antioxidant.

Uses For the treatment and control of diseases in cattle, sheep and pigs caused by or associated with organisms sensitive to oxytetracycline.

These include: Pasteurella spp., Salmonella spp. Escherichia coli, Listeria spp Dosage and Administration By deep intramuscular injection.

1ml per 10kg bodyweight, equivalent to 20mg oxytetracycline per kg bodyweight.

Maximum volume at one injection site: Cattle, Sheep and Pigs - 10ml.

Pigs under 10kg, maximum dose 1ml.

Because of the sustained blood levels attained at the above dosage rates with Tetroxy LA one treatment is usually sufficient.

Contra-indications, Warnings, etc.

For animal treatment only.

Not to be used in cats, dogs, horses and donkeys.

Not for use in ewes producing milk for human consumption.

The use of Tetroxy LA during the period of tooth development including late pregnancy, may lead to tooth discoloration. Occasionally local reaction of a transient nature may

occur at the site of injection.

Legal Category POM

Operator Warnings Avoid contact with the eyes.

Wash hands after use.

Package Quantities 100ml multidose injection

VPA 10126/10/1

Withdrawal Periods Cattle and sheep for human consumption should not be slaughtered within 28 days of treatment.

Pigs for human consumption should not be slaughtered within 21 days of treatment.

Not for use in sheep producing milk for human consumption.

Milk intended for human consumption or the manufacture of cheese and yoghurt should not be drawn from treated animals within 7 days after treatment. Milk may only be taken from the 15th milking with a twice a day milking programme.

Pharmaceutical Precautions Keep out of reach and sight of children.

Do not store above 25째C. Avoid the introduction of contamination during use.

Should any apparent growth occur, the product should be discarded.

Following withdrawal of the first dose, the product should be used within 28 days.

The product should not be diluted with solutions of calcium salts as this causes precipitation.

Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste under national waste disposal regulations.

www.bimeda.ie 107

PRODUCT INFORMATION

TONAVET Vitamin A, D3 & E Vitamin B1, B2 & B6 Calcium, Phosphorus, Potassium, Sodium Magnesium, Iron, Manganese, Copper & Zinc INDICATIONS A vitamin and mineral supplement for oral administration for oral administration to calves, piglets and other domestic animals.

BENEFITS • Highly palatable as molasses based • Can be mixed with feed • Cost effective supplementation • Multi vitamin trace element mineral tonic for performance or recovery animals • Wide animal spectrum for usage

PACKAGING LIST NO.

UNIT PACKAGE

1TON001

2.5L

CASE SIZE 6

1TON002

500ml

12

See reverse side for full indications, administration and dosage.

Bimeda® Broomhill Road Tallaght Dublin 24, Ireland Tel: 1850-515253 108

www.bimeda.ie

TECHNICAL INFORMATION

TONAVET Presentation A vitamin, mineral and trace element suspension.

Each 60 ml contains: Vitamins: Vitamin A 40,000 i.u., Vitamin B1 (Thiamine) 24 mg, Vitamin B2 (Riboflavin) 40 mg, Vitamin B6 (Pyridoxine) 12 mg, Niacin 120 mg, Vitamin D3 6,000 i.u., Vitamin E 80 mg.

Minerals: Calcium 3,400 mg, Phorphorus 2, 628 mg, Potassium 972 mg, Sodium 920 mg, Magnesium 143 mg.

ml (1/4 fl oz.) daily, Pigs 30 ml (1 fl. oz) daily. Continue treatment for 8 - 10 days.

Contra-indications, Warnings, etc.

For animal use only.

Not to be used in animals known to be hypersensitive to any of the ingredients.

Pharmaceutical Precautions Shake well before use.

Keep out of reach of children.

Trace Elements: Iron 68 mg, Manganese 12.6 mg, Copper 9.2 mg, Zinc 9.2 mg, Iodine 1.08 mg, Cobalt 1.44 mg.

Uses A vitamin and mineral supplement for oral administration to calves, piglets and other domestic animals.

Dosage and Administration Calves 15 ml (1/2 fl oz.) daily, Cattle 60 ml (2 fl oz.) daily, Bonhams 10

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PRODUCT INFORMATION

TYLOVET 20% Tylosin

INDICATIONS For the treatment of infections caused by microorganisms susceptible to tylosin.

BENEFITS • Tylosin Tartrate base, readily soluble in water • Broad spectrum activity against Gram positive and Gram-negative organisms in cattle, sheep and pigs • Excellent at reducing sub clinical mastitis and SCC issues at drying off in dairy cows • Short withdrawals, milk 4 days and meat 21 days • A proven performer

PACKAGING LIST NO.

UNIT PACKAGE

CASE SIZE

1TYL009

100ml

12

See reverse side for full indications, administration and dosage.

Bimeda® Broomhill Road Tallaght Dublin 24, Ireland Tel: 1850-515253 110

www.bimeda.ie

TECHNICAL INFORMATION

TYLOVET 20% W/V SOLUTION FOR INJECTION Presentation A clear yellow solution for injection.

Each ml contains: Tylosin (as Tylosin Tartrate) 200.0 mg Target Species Cattle, pigs.

Uses For the treatment of infections caused by microorganisms susceptible to tylosin. The spectrum of antimicrobial activity of tylosin includes: Staphylococcus spp Streptococcus spp.

Corynebacterium spp.

Neisseria spp.

Flavobacterium spp.

Campylobacter spp.

Bacillus anthracis Moraxella bovis Clostridium spp.

Haemophilus spp.

Bordetella bronchiseptica Spirochaetes Bacteroides spp.

Mycoplasma spp.

Contraindications, Warnings etc Do not use in case of hypersensitivity to the active ingredient or to any other macrolide antibiotics.

Do not use in new-born animals.

Do not use in equines.

Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

The safety of the veterinary

medicinal product has not been established during pregnancy and lactation.

Use only according to the benefit/ risk assessment by the responsible veterinarian.

Operator Warnings Avoid skin contact with solution.

Doses and Administration The recommended dosage rate is 10 mg/kg bodyweight twice daily i.e 0.5 ml per 10 kg body weight. For intramuscular administration.

Treatment should be carried out for 3 to 5 consecutive days. To ensure a correct dosage, bodyweight should be determined as accurately as possible.

Packaging 100 ml amber coloured type II glass vial sealed with butyl rubber stoppers and aluminium cap.

LEGAL CATEGORY POM Disposal Any unused product or waste materials should be disposed of in accordance with national requirements VPA 10989/008/001

Overdose Overdose should be avoided using the most accurate bodyweight estimation.

Withdrawal Period(s) Meat and offal: 21 days.

Milk: 96 hours.

Incompatibilities Do not mix with any other medicinal products.

Shelf-life Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf-life after first opening the immediate packaging: 14 days.

Storage Store in a refrigerator (2ยบC - 8ยบC).

Protect from light. Do not freeze.

www.bimeda.ie 111

PRODUCT INFORMATION PRODUCT

UNISOL

100 mg/ml solution for injection for cattle and pigs

Enrofloxacin 100mg/ml INDICATIONS Treatment of bacterial infections caused by strains susceptible to enrofloxacin.

BENEFITS • Contains high level of enrofloxacin • Can be injected intravenously in cases of peracute mastitis • Bactericidal antibiotic • Active against wide range of gram positive and gram negative bacteria and mycoplasmas

PACKAGING

Bimeda®® Bimeda Broomhill Broomhill Road Road Tallaght Tallaght Dublin 24, Ireland Dublin 24, Ireland Tel: 1850-515253 Fax: 01 451 5803 Tel: 1850-515253 112

LIST NO.

UNIT PACKAGE

CASE SIZE

1UNI001

100ml

12

See reverse side for Administration and Dosage.

www.bimeda.ie www.bimeda.ie

TECHNICAL INFORMATION

UNISOL

100 mg/ml solution for injection for cattle and pigs CATTLE Respiratory infections caused by Pasteurella spp. or Mycoplasma spp.

Alimentary tract infections caused by E. coli.

Treatment of local signs (inflammation, milk quality and yield) associated with peracute/acute mastitis in lactating dairy cattle caused by E. coli.

PIGS Respiratory infections caused by of Pasteurella spp. or Mycoplasma spp.

Alimentary tract infections caused by E. coli.

Enrofloxacin should be used where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.

PRESENTATION Solution for injection Clear slightly yellowish solution Each 1 ml of solution contains: 2.1 Active Constituents

Enroloxacin 100.0 mg 2.2 Relevant Constituents of the Excipients

Benzyl alcohol 7.8mg

Disodium edetate 10.0mg LIST OF EXCIPIENTS

Benzyl alcohol

Disodium edetate

Potassium hydroxide

Glacial acetic acid

Water for injections USES For the treatment of diseases in cattle and pigs involving organisms sensitive to Enrofloxacin, including Respiratory infections caused by Pasteurella spp. or Mycoplasma spp. Mastitic and Alimentary tract infections caused by E. coli.

Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.

DOSAGE AND ADMINISTRATION To ensure correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

Cattle: For respiratory and alimentary infections in cattle and secondary bacterial infections: administer by subcutaneous injection. • 2.5 mg enrofloxacin per kg bodyweight daily by subcutaneous injection for 3 days (2.5 ml per 100 kg bodyweight). This rate may be doubled to 5 mg/kg bodyweight (5 ml per 100 kg) for 5 days for complicated respiratory disease.

Not more than 10 ml should be administered at any one subcutaneous injection site.

For E. coli mastitis: administer by slow intravenous injection. • 5.0 ml per 100 kg bodyweight (5 mg enrofloxacin per kg bodyweight) daily for 2 days Pigs:

For respiratory and alimentary infections in pigs and secondary bacterial infections: administer by intramuscular injection.

2.5 mg enrofloxacin per kg bodyweight daily by intramuscular injection for 3 days (2.5 ml per 100 kg bodyweight). This rate may be doubled to 5 mg/kg bodyweight (5 ml per 100 kg) for 5 days for complicated respiratory disease.

Not more than 2.5 ml should be administered at any one intramuscular injection site.

The stopper should not be punctured more than 20 times.

CONTRAINDICATIONS AND WARNINGS i. Special precautions for use in animals The safety of the product has not been established in pigs or calves when administered by the intravenous route and use of this route of administration is not recommended in these animal groups.

Do not exceed the recommended dose.

Repeat injections should be administered at different sites.

Enrofloxacin should be used with caution in epileptic animals or animals affected by renal dysfunction.

Official and local antimicrobial policies should be taken into account when the product is used.

Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.

Whenever possible, fluoroquinolones should only be used based on susceptibility testing.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance. ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals The product is an alkaline solution. Wash any splashes from skin or eyes immediately with water.

Do not eat, drink or smoke whilst using the product.

Care should be taken to avoid accidental selfinjection.

If accidental self injection occurs seek medical advice immediately.

Direct contact with the skin should be avoided because of sensitisation, contact dermatitis and possible hypersensitivity reactions. Wear gloves. iii. Other precautions None known Adverse reactions (frequency and seriousness) Local tissue reactions may occasionally occur at the injection site. Normal sterile precautions should be taken.

Rarely, anaphylactic reactions may occur following intravenous administration.

In cattle, gastrointestinal disturbances may occasionally occur.

Use during pregnancy, lactation or lay There is no restriction on the use of this product during pregnancy and lactation.

Interactions with other medicinal products and other form of interaction Antagonistic effects due to concurrent administration of macrolides, and tetracyclines may occur Enrofloxacin may interfere with the metabolism of theophylline, decreasing theophylline clearance resulting in increased plasma levels of theophylline.

WITHDRAWAL PERIODS Cattle: Subcutaneous Use Meat and offal: 13 days Milk: 84 hours Cattle: Intravenous Use Meat and offal: 4 days Milk: 72 hours Pigs: Intramuscular Use Meat and offal: 10 days PHARMACEUTICAL PRECAUTIONS: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

SHELF LIFE: Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 28 days.

SPECIAL PRECAUTIONS FOR STORAGE: Protect from light.

Do not freeze SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE DERIVED FROM THE USE OF SUCH PRODUCTS Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

LEGAL CATEGORY:

POM

PACKAGE QUANTITIES: Multi-dose glass vials MARKETING AUTHORISATION HOLDER: Bimeda Chemicals Ltd., Unit 2, Bryn Cefni Industrial Park, Llangefni, Anglesey, Wales, LL777XA MARKETING AUTHORISATION NUMBER: VPA 10516/001/001

www.bimeda.ie 113

PRODUCT INFORMATION

VETRISUL INJECTION Trimethoprim Sulphamethoxazole INDICATIONS Infections caused by micro-organisms susceptible to trimethoprim and/or sulfamethoxazole.

BENEFITS • A synergistic and antibacterial effect occurs when both Sulphamethoxazole and Trimethoprim are combined • Treats a wide range of diseases in cattle such as in the respiratory, alimentary and urinary tract infections • IM administration route • Can be used in dairy cattle

PACKAGING LIST NO.

UNIT PACKAGE

CASE SIZE

1VET005

100ml

12

See reverse side for full indications, administration and dosage.

Bimeda® Broomhill Road Tallaght Dublin 24, Ireland Tel: 1850-515253 114

www.bimeda.ie

TECHNICAL INFORMATION

VETRUSIL INJECTION Presentation Amber Type II 100ml vial, sealed with a rubber butyl stopper, with an aluminium cap containing per ml: Trimethoprim 40 mg Sulphamethoxazole 200 mg Benzyl Alcohol 9.0 mg N, N-Dimethylacetamide 170 mg Pharmaceutical Form Solution for Injection.

Target Species Cattle.

Uses Infections caused by microorganisms susceptible to trimethoprim and/or sulfamethoxazole.

Contraindications, warnings etc Do not use in case of hypersensitivity to the active substances or to any of the excipients.

Do not use in animals with impaired liver or kidney function.

Folic acid deficiency, crystaluria and/or blood dycrasias may occur, especially if treatment is prolonged.

Occasionally, temporary swellings at the injection site may occur (for this reason subcutaneous injections should be avoided).

The combination is in theory

incompatible with paraaminobenzoic acid and esters of it (lidocaine, procaine etc.).

Operator Warnings Avoid skin contact with the solution.

Use during pregnancy, lactation or lay The active ingredients are excreted in milk and may thus be transmitted to sucklings. No adverse effects are anticipated at the recommended dose during pregnancy and lactation.

Dosage and Administration Vetrisul 100 ml injection is indicated for intramuscular administration only.

The general dose is 1 ml per 10-15 kg body weight daily This dose may be repeated daily for a period of 3 - 5 days, according to clinical response.

Shelf-life Shelf-life of the veterinary medicinal product as packaged for sale: 3 years Shelf-life after first opening the immediate packaging: 14 days.

Storage Do not store above 25째C. Do not freeze. Protect from light.

Disposal advice Any unused product or waste material should be disposed of in accordance with national requirements LEGAL CATEGORY POM VPA 10989/009/001

Withdrawal Period(s) Meat and offal: 35 days.

Milk: 5 days.

Incompatibilities Do not mix with any other medicinal products.

www.bimeda.ie 115

PRODUCT INFORMATION

VITAMIN B1 Thiamine Hydrochloride

INDICATIONS For the treatment of cerebrocortical necrosis in cattle and sheep and as an adjunct in metabolic disorders in cattle.

BENEFITS • Treats cerebrocortical necrosis in cattle and sheep and as an adjunct in metabolic disorders in cattle • Can be administered by IM or slow IV • No undesirable effects noted during pregnancy or lactation • Nil withdrawals

PACKAGING LIST NO.

UNIT PACKAGE

CASE SIZE

1VIT001

50ml

12

See reverse side for full indications, administration and dosage.

Bimeda® Broomhill Road Tallaght Dublin 24, Ireland Tel: 1850-515253 116

www.bimeda.ie

TECHNICAL INFORMATION

VITAMIN B1 INJECTION Presentation A clear, sterile aqueous solution for parenteral administration. Each ml contains 100mg Thiamine Hydrochloride. Also contains Benzyl Alcohol (preservative).

Uses For the treatment of cerebrocortical necrosis in cattle and sheep and as an adjunct in metabolic disorders in cattle.

Dosage and Administration To be administered by intramuscular or slow intravenous injection.

Cattle and sheep for cerebrocortical necrosis: 2.5 - 5ml per 50kg bodyweight. Repeat every 3 hours for up to a total of 5 doses.

Contra-indications, Warnings, etc.

For animal treatment only.

Not to be used in animals known to be hypersensitive to the active ingredient.

Intravenous injections should be given slowly (ie over 20 seconds).

Observe aseptic techniques.

It is not anticipated that the use of Vitamin B1 Injection will lead to any undesirable effects during pregnancy and/or lactation.

Pharmaceutical Precautions Keep out of reach and sight of children.

Do not store above 25째C and protect from light.

Following withdrawal of the first dose, use the product within 28 days. Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste under national waste disposal regulations.

Avoid the introduction of contamination during use.

Should any apparent growth or discoloration occur the product should be discarded.

LEGAL CATEGORY POM Package Quantities Multi-dose vials of 50ml.

VPA 10126/50/1

Withdrawal Periods Meat/Milk: Nil.

www.bimeda.ie 117

PRODUCT INFORMATION

VITAMIN K1 Phytomenadione

INDICATIONS Vitamin K1 Injection is indicated in th e treament of hypoprothrombinaemia associated with poisoning by warfarin or other coumarins.

BENEFITS • An aqueous colloidal solution • Suitable for parenteral administration to domestic animals • Treats domestic animals exposed to poisoning by Warfarin or other coumarins • Short withholding times

PACKAGING LIST NO.

UNIT PACKAGE

CASE SIZE

1VIT014

50ml

12

See reverse side for full indications, administration and dosage.

Bimeda® Broomhill Road Tallaght Dublin 24, Ireland Tel: 1850-515253 118

www.bimeda.ie

TECHNICAL INFORMATION

VITAMIN K1 INJECTION Presentation A clear to slightly opalescent, pale yellow aqueous colloidal solution, suitable for parenteral administration to domestic animals. Each ml contains: 10mg Phytomenadione (Vitamin K1). Also contains Benzyl alcohol (preservative), butylated hydroxyanisole (antioxidant) and butylated hydroxytoluene (antioxidant).

Uses For the treatment of hypoprothrombinaemia in domestic animals associated with poisoning

by Warfarin or other coumarins.

Dosage and Administration To be administered by intramuscular, subcutaneous or slow intravenous injection.

Dogs & Cats 0.25 - 2.5mg/kg bodyweight Large animals 0.5 - 2.5mg/kg bodyweight Daily dosing should continue for four days. In severe cases of anaemia the dosage may be increased to 5mg/kg bodyweight for 4 days followed by oral Vitamin K1 therapy.

Contra-indications, Warnings, etc.

For animal treatment only.

Not to be used in animals known to be hypersensitive to the active ingredient.

Anaphylactoid and other hypersensitivity reactions may occur following intravenous administration. Fatalities have occurred with products of this

kind although it is unclear whether these reactions were caused by phytomenadione itself or by surfactants included in the formulation.

Pain and swelling may occur at injection sites following administration of Phytomenadione.

Intravenous injections should be given slowly (ie over 30 - 40 seconds).

Acute haemorrhage may also require transfusion therapy.

Phytomenadione will not counteract the anticoagulant action of heparin.

of reach and sight of children.

Do not store above 25째C and protect from light. Do not allow the injection to freeze.

If separation has occurred or if oil droplets have appeared, the injection should not be used. Avoid the introduction of contamination during use. Should any apparent growth or discoloration occur the product should be discarded.

Following withdrawal of the first dose, use the product within 7 days.

Withdrawal Periods Milk Withholding Time Milk intended for human consumption must not be taken from a cow during treatment. Milk for human consumption may be taken only after 7 days from the last treatment.

Legal category POM Package Quantities Multi-dose vials of 50ml.

VPA 10126/37/1

Meat Withholding Time Animals intended for human consumption should not be slaughtered during treatment.

Animals for human consumption may be slaughtered for human consumption only after 28 days from the last treatment.

Interaction with Other Medicaments and other Forms of Interaction As Vitamin K1 possibly acts by competitive antagonism of coumarins, the efficacy of Vitamin K1 will be reduced by continued dosage of coumarins.

Pharmaceutical Precautions For animal treatment only. Keep out

www.bimeda.ie 119

Index A-M D

A ABINEX FORTE POUR-ON

12, 13

B BICOLOST B BILOSIN 200 INJECTION BIMADINE POWDER BIMASTAT BIMECTIN INJECTION BIMECTIN ORAL PASTE BIMECTIN PLUS BIMECTIN POUR-ON BIMOTRIM CO INJECTION BIMOXYL LA INJECTION BOVIFERM PLUS BOVIMAST DC BOVISAL PEARLS BOVISEAL NA

32, 33 14, 15 16, 17 22, 23 24, 25 26, 27 30, 31 28, 29 18, 19 20, 21 40, 41 38, 39 34, 35 36, 37

56, 57 58, 59

E ECTOFLITS ECTOFLY ECTOSPEC EFICUR 50 mg/ml EMBOTAPE ENDOSPEC 2.5% SC ENDOSPEC 10% ENDOFLUKE 10% EQUIBACTIN VET.

60, 61 62, 63 64, 65 66, 67 68, 69 70, 71 72, 73 74, 75 76, 77

F FLEE

78, 79

H

C CALCIUM BOVISAL CONVITAL EQUILYTES CONVITAL R CRONYXIN INJECTION CYCLOSOL LA CYCLO SPRAY CYPERGUARD

DIPEN D-MITE

42, 43 44, 45 46, 47 48, 49 52, 53 50, 51 54, 55

HELODIP HYSPAN

80, 81 82, 83

K KEFAMAST DC 84, 85 KEFAMAST LACTATING COW 86, 87

M MULTIMAST DRY COW

120

88, 89

Index O-Z N NEFOTEK

U 90, 91

O OSMODEX OXYCOMPLEX NS OXYTOCIN Pro Injection

92, 93 94, 95 96, 97

UNISOL

112, 113

V VETRUSIL INJECTION VITAMIN B1 INJECTION VITAMIN K1 INJECTION

114, 115 116, 117 118, 119

R RAPIDEXON

98, 99

S SEDAXYLAN SELECTAN SODIUM POWDER

100, 101 102, 103 104, 105

T TETROXY LA TONAVET TYLOVET 20%

106, 107 108, 109 110, 111

121

Your Local Representative from Bimeda Andrew Glynn, Sales Manager for Ireland (Veterinary and Co Operatives) aglynn@bimeda.com 087 2525110

Shane Kinsella, Co Operative Sales Representative (Munster & Leinster) skinsella@bimeda.com 086 0493960

Denis Carney, Veterinary sales Representative (South East Ireland), dcarney@bimeda.com 087 2576925

Morgan Lane, Co Operative Sales Representative (West of Ireland & Midlands) mlane@bimeda.com 087 2568346

John Reynolds, Veterinary Sales Representative (Dublin, Midlands and West of Ireland) jreynolds@bimeda.com 087 8097059

Paudie Hyland Bimeda Commercial Vet phyland@bimeda.com 086 0433388

John Sheerin Veterinary Sales Representative (Munster) jsheerin@bimeda.com 087 2576926

122

Bimeda速 Broomhill Road Tallaght Dublin 24, Ireland Tel: 1850-515253

www.bimeda.ie