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
PACKAGING
Bimeda® Broomhill Road, Tallaght Dublin 24, Ireland Tel: 1850-515253 Fax: 01 451 5803 Bryn Cefni Industrial Park, Llangefni, Anglesey, Wales, LL777XA UK +44 (0) 800 526769
LIST NO.
UNIT PACKAGE
CASE SIZE
1NEF001
100ml
12
1NEF002
250ml
12
See reverse side for Administration and Dosage.
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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 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 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 nonsteroidal anti-inflammatory 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 non-steroidal antiinflammatorys 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 AND STORAGE - 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 25 o C - Store in the original package. - Protect from light. 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
POM-V
Ireland UK
MARKETING AUTHORISATION HOLDER: Bimeda Chemicals Ltd., Broomhill Road, Tallaght, Dublin 24, Ireland. MARKETING AUTHORISATION NUMBER: VPA 10516/001/001 VM 32509/4008
www.bimeda.com