http://www.bimeda.ie/docs/ukdocs/Tetroxy_LA_Data_Sheet

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PRODUCT INFORMATION

TETROXY LA Oxytetracycline

BENEFITS • • • • • • •

Convenience, one treatment usually sufficient, reduces labour 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. 1TET017

UNIT PACKAGE 100ml

CASE SIZE 12

See reverse side for full indications, administration and dosage.

Bimeda® A division of Cross Vetpharm Group UK Limited Unit 2, Bryn Cefni Industrial Park, Llangefni, Anglesey, LL77 7XA Tel: 01248 725 400 Fax: 01248 725 416 Web: www.bimeda.co.uk


TECHNICAL PRODUCT INFORMATION INFORMATION

TETROXY LA Presentation A clear yellow to amber aqueous solution for injection. Each ml contains 200mg Oxytetracyline (as oxytetracycline dihydrate ) Target Species Cattle, Sheep and Pigs. Indications for use Tetroxy L.A. is indicated in the treatment and control of diseases caused by or associated with organisms sensitive to Oxytetracycline in cattle, sheep and pigs. Contradictions Not recommended for cats, dogs, horses and donkeys. Special Warnings for each target species Prolonged use of anti-infectives may result in super infection by non-susceptible organisms. Photodermatitis may occasionally occur after treatment under strong exposure to sunlight. Special Precautions For Use (i) Special precautions for use in animals Following withdrawal of the first dose, use the product within 28 days. Not recommended in cases of renal impairment (see also 4.4 above). Discard unused material. (ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals. Take care to avoid accidental self injection. In case of contact with eyes or skin, wash immediately with plenty of water as irritation may occur. Wash hands after use. Adverse reactions ( frequency and seriousness) Occasional local reaction of a transient nature may occur at the site of injection. Use During Pregnancy , Lactation or lay The use of Tetroxy L.A. during the period of tooth development including late pregnancy may lead to discoloration. Interaction with Other Medicinal products and other Forms of interactions Do not dilute. It is unwise to administer bacteriostatic and bactericidal antibiotics concurrently. Amounts to be administered and administration route Tetroxy L.A. is administered by deep intramuscular injection at the rate of 1 ml per 10kg bodyweight which is equivalent to 20mg Oxytetracycline per kg.

It is recommended that the following amounts of Tetroxy L.A. at one site should not be exceeded: Cattle, Sheep and Pigs - 10 ml Pigs under 10 kg - maximum dose of 1 ml Effective blood levels are maintained for up to 72 hours in cattle and 48 hours in pigs and sheep. Because of the sustained blood levels attained at the above dosage rates with Tetroxy L.A., this is a single dose treatment. Overdose

Not applicable.

Withdrawal Periods Cattle (meat & offal): 39 days Pigs (meat & offal): 70 days Sheep (meat & offal): 28 days Do not use in animals producing milk for human consumption. Incompatibilities (major) Tetroxy L.A. should not be brought into contact with calcium solutions. Do not dilute. 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. Discard unused material. Special Precautions for Storage Do not store above 25°C. Protect from light. Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from use of such products, if appropriate Any unused veterinary medicinal product or waste material s 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 Vm 02676/4137 Legal Category POM-V Package Quantities: 100ml Multidose Vial A full product SPC is available on request from Bimeda or alternatively can be found on the VMD website

BimedaÂŽ A division of Cross Vetpharm Group UK Limited Unit 2, Bryn Cefni Industrial Park, Llangefni, Anglesey, LL77 7XA Tel: 01248 725 400 Fax: 01248 725 416 Web: www.bimeda.co.uk


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