Target species
Cattle, pigs, dogs and cats.
Indications for use
Treatment of infections caused by, or associated with, organisms sensitive to the trimethoprim-sulfadiazine combination.
Contraindications
Do not use in case of hypersensitivity to the active substances of to any of the excipients.
Do not use in animals with severe liver or renal damage or blood dyscrasias.
Do not use in case of reduced water intake or losses of body fluid.
Special precautions for use in animals
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.
Use of the product deviating from the instructions given in this datasheet 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.
Official, national and regional antimicrobial policies should be taken into account when the product is used.
For intravenous administration the product should be warmed to body temperature and injected slowly over as long a period as is reasonably practical. At the first sign of intolerance the injection should be interrupted and shock treatment initiated. Intravenous administration should be used with extreme caution and only if therapeutically justified.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
The product may cause an allergic reaction in people sensitised to sulfonamides.
People with known hypersensitivity to sulfonamides should avoid contact with the veterinary medicinal product.
The excipient N-methylpyrrolidone (NMP) is a suspected human teratogen; therefore, women of child-bearing age must be very careful to avoid exposure via spillage onto the skin or accidental self-injection when administering the product. If you are pregnant, think you may be pregnant or are attempting to conceive, you should not administer the product.
If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.
This product may cause skin and eye irritation. Avoid contact with skin or eyes. In case of skin or eye contact, wash exposed area with plenty of clean water. If symptoms persist, seek medical advice.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Wash hands after use.
Adverse reactions
Anaphylactic shock (potentially fatal) has been observed on rare occasions (more than 1 but less than 10 animals in 10,000 animals treated) following administration of potentiated sulphonamide preparations, mostly after intravenous injection. For intravenous administration, the product should be warmed to body temperature and injected slowly over as long a period as is reasonably practical. At the first sign of intolerance the injection should be interrupted and shock treatment initiated.
Use during pregnancy and lactation
Can be safely administered to lactating animals. The product contains N-methylpyrrolidone, which is considered to be a reproductive toxicant. As the relevant studies have not been performed, use in pregnant cattle, pigs, dogs and cats should be avoided.
Interactions
Local anaesthetics from the group of para-aminobenzoic acid esters (procaine, tetracaine) can locally inhibit the effect of sulfonamides. Do not combine with other veterinary medicinal products.
Amounts to be administered and administration route
For intramuscular, intravenous or subcutaneous use.
To ensure correct dosage, the body weight of animals to be treated should be determined as accurately as possible.
Cattle and pigs:
The recommended dose rate is 2.5 mg trimethoprim/12.5 mg sulfadiazine per kilogram body weight (1 ml product per 16 kg body weight) by intramuscular or slow intravenous injection, once daily until 2 days after symptoms resolve up to a maximum of 5 days. The maximum intramuscular volume of injection per injection site is 5 ml for pigs and 15 ml in cattle. The veterinary medicinal product may be administered by intravenous injection when blood levels of trimethoprim and sulfadiazine are required more rapidly.
Dogs and cats:
The recommended dose rate is 5 mg trimethoprim/25 mg sulfadiazine per kilogram body weight (1 ml product per 8 kg body weight) by subcutaneous injection only, once daily until 2 days after symptoms resolve up to a maximum of 5 days. The recommended injection site in dogs is the loose skin at the top of the neck.
The closures must not be punctured more than 40 times.
Withdrawal periods
Cattle: Meat and offal: 12 days
Milk: 48 hours
Pigs: Meat and offal: 20 days