TETROXY LA 2 00 mg / ml S o l u t i o n fo r In je c tio n STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) A long acting oxytetracycline solution for injection. Each ml contains Oxytetracycline 200 mg (as Oxytetracycline Dihydrate). Also contains Povidone and N-methyl-pyrrolidone as co-solvents and Sodium formaldehyde sulfoxylate 2.7 mg/ml as an antioxidant. INDICATION(S) 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 CONTRA-INDICATIONS Do not use in cats, dogs, horses and donkeys. Do not use in sheep producing milk for human consumption. ADVERSE REACTIONS The use of Tetroxy LA during the period of tooth development, including late pregnancy, may lead to tooth discolourisation Occasional local reactions of a transient nature may occur at the site of injection. TARGET SPECIES Cattle, Sheep and pigs. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION By deep intramuscular injection To ensure a correct dosage, bodyweight should be as accurate as possible. 1 ml per 10 kg bodyweight, equivalent to 20 mg oxytetracycline per kg bodyweight. Maximum volume at one injection site Cattle: 10 ml Sheep: 10 ml Pigs: 10 ml Pigs under 10 kg, maximum dose 1 ml. Bacause of the sustained blood levels attained at the above dosage rates with Tetroxy LA, one treatment is usually sufficient. WITHDRAWAL PERIOD Pigs for human consumption should not be slaughtered within 21 days of treatment. Cattle and sheep for human consumption should not be slaughtered within 28 days of treatment. Milk intended for human consumption or the manufacture of cheese or yogurt should not be drawn from treated animals within 7 days after treatment. Milk may only be taken from the 15th milking with a twice daily milking programme. Do not use in sheep producing milk for human consumption. SPECIAL STORAGE PRECAUTIONS Do not store above 25Ëšc. Protect from light After broaching, the product should be used within 28 days. Keep out of reach and sight of children. SPECIAL WARNING(S) 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. Tetroxy LA should not be diluted with solutions of calcium salts as this causes precipitation. Avoid contact with the eyes. Wash hands after use. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED 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. OTHER INFORMATYION VPA 10126/10/1 POM
Prescription Only Medicine