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Date: Sunday, February 25, 2024 8:32

Release 3.124
Trimediazine™ Plain Oral Powder
 
Species: Horses and other equidae
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Others
Active ingredient: Sulfadiazine (Sulphadiazine), Trimethoprim
Product:Trimediazine™ Plain Oral Powder
Product index: Trimediazine Plain
Withdrawal notes: Horse meat: 6 months
Incorporating:
Presentation
Trimediazine Plain is a white broad spectrum antibacterial powder for mixing with animal feed . Each sachet contains Trimethoprim 5% w/w and Sulfadiazine 25% w/w.
Uses
Trimediazine Plain is indicated for use in the treatment of bacterial diseases in horses, including upper and lower respiratory tract infections, alimentary tract infections and infected wounds.
Dosage and administration
For oral administration in the feed. To be given at a rate of 30mg combined active ingredients per kg bodyweight.
Mix with a small quantity of feed. Each 50 g sachet provides a daily dose for a 500 kg horse. The dose may be administered daily, or divided and administered at 12 hourly intervals, for 5 days.
Note
It is recommended that other feed be withdrawn until medicated feed has been consumed.
Contra-indications, warnings, etc
Do not use in horses with severe liver parenchymal damage or kidney damage or known sulphonamide sensitivity, or horses with blood dyscrasias or cardiac arrhythmias. Do not exceed 7 days continuous treatment
The use of Trimediazine Plain in horses under 1 year old should be avoided.
In the rat and rabbit, trimethoprim/sulfadiazine combinations did not produce any foetal abnormalities at doses of up to 600mg/kg, although minor effects on skeletal development were seen below this level. As no studies have been conducted in horses, use on pregnant mares should be avoided.
When administered to lactating females, small amounts of trimethoprim and sulfadiazine are present in the maternal milk. Since no studies have been reported on the effects of Trimediazine Plain on the development of new born foals, it would be prudent not to feed very young foals with milk obtained from mares being treated.
As there is no specific antidote, in case of overdose, treatment should be symptomatic.
Withdrawal period
Meat: 6 months
Persons handling this product should avoid inhalation of any dust and contact with skin. Wear either a disposable half-mask respirator conforming to European Standard to EN149 or a non-disposable respirator to European Standard to EN140 with filter EN143 when mixing or handling this product. Rubber gloves should be worn when mixing or handling this product. Hands should be washed thoroughly 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 a skin rash, you should seek medical advice and show the doctor this warning.
Pharmaceutical precautions
Do not store above 25°C. Store in a dry place away from animal feeding stuffs. Add to feed immediately before administration. Discard any remaining medicated feed.
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
Legal category: POM-V
Packaging quantities
10×50 g sachets.
Further information
ATC vet code: QJ01EW10
Sulfadiazine is a bacteriostatic antibiotic belonging to the sulphonamide group which acts by interference with the synthesis of nucleic acids. Trimethoprim is a reductase inhibitor which also interferes with the synthesis of bacterial nucleic acids. Sulfadiazine and trimethoprim act on the same metabolic pathway, resulting in potentiation of antibacterial activity.
Marketing Authorisation Number
Vm 08007/4036.
Significant changes
GTIN
GTIN description:Trimediazine Plain
GTIN:03605870009886