Description

Diatrim 200 mg/ml + 40 mg/ml solution for injection for cattle, pigs, dogs and cats. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: Active ingredients: Sulfadiazine 200 mg Trimethoprim 40 mg Excipients: Qualitative composition of the excipients and other components Quantitative composition, if such information is essential for correct administration of the veterinary medicinal product N-methylpyrrolidone 510 mg/ml Sodium hydroxide (E524) Disodium edetate Sodium formaldehyde sulfoxylate Water for injections Clear, greenish-yellow to brown-yellow solution, practically free of particles. 3. CLINICAL INFORMATION 3.1 Target species Cattle, pigs, dogs and cats. 3.2 Indications for use for each target species Treatment of infections caused by or associated with organisms sensitive to the trimethoprim-sulfadiazine combination. 3.3 Contraindications Do not use in cases of hypersensitivity to the active substances or to any of the excipients. Do not use in animals with severe liver or kidney disease or blood dyscrasia. Do not use in cases of reduced water intake or loss of body fluids. 3.4 Special warnings None. 3.5 Special precautions for use Special precautions for safe use in the target species: The use of the veterinary medicinal product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, treatment should be based on local (regional, farm level) epidemiological information on the susceptibility of the target bacteria. Use of the veterinary medicinal product under conditions other than those recommended in the summary of product characteristics may increase the prevalence of bacteria resistant to the veterinary medicinal product and decrease the efficacy of treatment with other antimicrobials or classes of antimicrobials due to the potential for cross-resistance. Use of the veterinary medicinal product should take into account official, national and regional antimicrobial recommendations. For intravenous administration, the veterinary medicinal product should be warmed to body temperature and injected slowly over as long a period of time as reasonably practicable. At the first signs of intolerance, the injection should be discontinued and anti-shock treatment initiated. Intravenous administration should be used with extreme caution and only if therapeutically justified.