Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Sulfamethoxazole, Trimethoprim
Eurovet Animal Health B.V.
QJ01EW11
Sulfamethoxazole, Trimethoprim
Oral solution
POM-V - Prescription Only Medicine – Veterinarian
Chickens, Pigs
Antimicrobial
Authorized
2016-07-07
Revised: February 2022 AN: 01447/2021 and 01448/2021 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Metaxol 20/100 mg/ml solution for use in drinking water for pigs and chickens 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml solution contains: ACTIVE SUBSTANCES: Trimethoprim 20 mg Sulfamethoxazole 100 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for use in drinking water. A clear, pale yellow to brownish-yellow solution. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Pigs (fattening pigs) and chickens (broilers). 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Fattening pigs: Treatment and metaphylaxis of: - Post-weaning diarrhoea caused by beta-haemolytic K88-positive, K99-positive or 987P _Escherichia coli_ strains susceptible to trimethoprim-sulfamethoxazole. - Secondary bacterial infections caused by _Pasteurella multocida_, _Actinobacillus _ _pleuropneumoniae_, _Streptococcus _spp. and _Haemophilus parasuis_ susceptible to trimethoprim-sulfamethoxazole. Broilers: Treatment and metaphylaxis of: - Colibacillosis caused by _Escherichia coli_ susceptible to trimethoprim- sulfamethoxazole. - Coryza caused by _Avibacterium paragallinarum _susceptible to trimethoprim- sulfamethoxazole. The presence of the disease in the group/flock must be established before the product is used. 4.3 CONTRAINDICATIONS Do not use in animals suffering from severe liver or kidney disease, oliguria or anuria. Revised: February 2022 AN: 01447/2021 and 01448/2021 Page 2 of 6 Do not use in animals with impaired haematopoietic systems. Do not use in case of known hypersensitivity to sulphonamides or trimethoprim or any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Severely diseased animals can have a decreased appetite and water consumption. If necessary the concentration of the VMP in the drinking water should be adjusted to make sure that the recommended dosage is being consumed. However if the concentration of the pro Read the complete document