Strinacin Ii Tablets
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1. |
NAME OF THE VETERINARY MEDICINAL PRODUCT |
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STRINACIN II Tablets |
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2. |
QUALITATIVE AND QUANTITATIVE COMPOSITION |
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Each bolus contains Trimethoprim 200 mg, Sulphadiazine 1.0 g and Amaranth dye (E123) 0.016% w/w. For full list of excipients, see section 6.1. |
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3. |
PHARMACEUTICAL FORM |
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Tablet. A scored pink bolus-shaped tablet for oral administration. |
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4. |
CLINICAL PARTICULARS |
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4.1 |
Target species |
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Calves. |
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4.2 |
Indications for use, specifying the target species |
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STRINACIN II is indicated primarily for the treatment of bacterial scours, but may also be used for the treatment of acute salmonellosis and bacterial pneumonia. |
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4.3 |
Contra-indications |
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STRINACIN II should not be administered to animals with functionally mature rumens. |
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4.4 |
Special warnings for each target species |
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Not to be administered to animals with a functionally mature rumen. |
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4.5 |
Special precautions for use |
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(i) Special precautions for use in animals |
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None. |
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(ii) Special precautions to be taken by the person administering the veterinary medicinal product to the animals |
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Protective gloves should be worn to avoid skin sensitisation, which may occur when crushing the bolus of this product. Wash hands after use. |
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Avoid direct contact with skin and eyes. If contact occurs, wash affected area with copious amounts of water. Seek medical advice if irritation persists. |
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4.6 |
Adverse reactions (frequency and seriousness) |
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No undesirable effects. |
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4.7 |
Use during pregnancy, lactation or lay |
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Not applicable. |
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4.8 |
Interaction with other medicinal products and other forms of interaction |
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No known interactions. |
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4.9 |
Amounts to be administered and administration route |
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For oral administration; STRINACIN II may be administered whole by hand or by balling gun, or may be dispersed in about 300ml water to be used as an oral drench. One bolus per 40 kg bodyweight daily. (This gives 30 mg of combined active ingredients per kilogram). Treatment should be repeated daily until two days after the symptoms have resolved. In cases of salmonellosis and bacterial pneumonia treatment must be continued for 5 consecutive days. |
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4.10 |
Overdose (symptoms, emergency procedures, antidotes), if necessary |
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The combination is well tolerated by calves. |
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4.11 |
Withdrawal periods |
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Calves: meat 15 days. |
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5. |
PHARMACOLOGICAL PROPERTIES |
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ATC Vet Code: QA07AB20 |
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Sulphadiazine (SDZ) inhibits the incorporation of para-aminobenzoic acid into folic acid, and Trimethoprim (TMP) inhibits the enzyme dihydrofolate reductase (DHFR) which converts dihydrofolic acid into tetrahydrofolic acid. The TMP and SDZ act together synergistically with a double-blockage mode of action. The combination is bactericidal, inhibiting sequential steps in the synthesis of purines which are required for DNA synthesis. TMP-SDZ combinations have a broad bactericidal action against many gram-positive and gram-negative aerobic bacteria, and a large proportion of anaerobic bacteria. |
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6. |
PHARMACEUTICAL PARTICULARS |
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6.1 |
List of excipients |
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Amarynth dye (E123) |
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6.2 |
Major incompatibilities |
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No major incompatibilities. |
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6.3 |
Shelf-life |
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Shelf-life of the veterinary medicinal product as packaged for sale: 3 years. |
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6.4 |
Special precautions for storage |
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Store in a dry place. Do not store above 25C. Protect from light. |
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6.5 |
Nature and composition of immediate packaging |
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STRINACIN II is marketed in white or grey polypropylene ‘securitainers’. Each container contains 20 or 50 tablets. |
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6.6 |
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate |
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Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements. |
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7. |
MARKETING AUTHORISATION HOLDER |
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Merial Animal Health Limited PO Box 327 Sandringham House Sandringham Avenue Harlow Business Park Harlow, Essex, CM19 5TG United Kingdom |
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8. |
MARKETING AUTHORISATION NUMBER(S) |
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Vm 08327/4058 |
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9. |
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION |
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28th June 2005 |
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10. |
DATE OF REVISION OF THE TEXT |
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December 2007. |
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11. |
ANY OTHER INFORMATION REQUIRED BY THE SECRETARY OF STATE |
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Not applicable. |