国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
SULFAMETHOXAZOLE, TRIMETHOPRIM
Eurovet Animal Health B.V.
QJ01EW11
SULFAMETHOXAZOLE, TRIMETHOPRIM
20/100
Oral Solution
POM
Fowl - Chicken, Porcine
Sulfamethoxazole and trimethoprime
Antibacterial
Authorised
2016-07-08
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 1 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. 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. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 08/07/2016_ _CRN 7020382_ _page number: 1_ 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Sever 阅读完整的文件