Target species
Horses.
Indications for use for each target species
The veterinary medicinal product 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.
Contra-indications
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.
Special warnings
The use of Trimediazine Plain in horses under 1 year old should be avoided.
Special precautions for use
Special precautions for safe use in the target species:
To avoid possible crystalluria, adequate water intake is essential.
Use of the product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target bacteria at farm level, or at local/regional level.
Use of the product should be in accordance with official, national and regional antimicrobial policies. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the product and may decrease the effectiveness of treatment with other antimicrobials or classes of antimicrobials due to the potential for cross-resistance.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Persons handling this veterinary medicinal product should avoid inhalation of any dust and contact with skin. Personal protective equipment consisting of a disposable half-mask respirator conforming to European Standard to EN149 or a non-disposable respirator to European Standard to EN140 with filter EN143 should be worn when mixing or handling the veterinary medicinal product. Rubber gloves should be worn when mixing or handling this veterinary medicinal 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.
People with known hypersensitivity to sulphonamides should avoid contact with the veterinary medicinal product.
If you develop symptoms following exposure such as a skin rash, seek medical advice and show the package leaflet or the label to the physician.
Special precautions for the protection of the environment:
Not applicable.
Adverse events
None known
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy and lactation:
Laboratory studies in the rat and the rabbit have not produced any evidence of foetal abnormalities at doses of up to 600 mg/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 the veterinary medicinal product on the development of new born foals, it would be prudent not to feed very young foals with milk obtained from mares being treated.
Interaction with other medicinal products and other forms of interaction
None known
Administration routes and dosage
Oral use. For administration in the feed.
To ensure a correct dosage, body weight should be determined as accurately as possible.
To be given at a rate of 30 mg 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 and may be administered daily or divided and administered at 12 hourly intervals, for 5 days.
It is recommended that other feed be withdrawn until medicated feed has been consumed.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No information available. As there is no specific antidote, treatment should be symptomatic.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal period(s)
Meat and offal: 6 months