国家: 英国
语言: 英文
来源: VMD (Veterinary Medicines Directorate)
Enrofloxacin
Chanelle Pharmaceuticals Manufacturing Ltd
QJ01MA90
Enrofloxacin
Expired
Revised: August 2012 AN: 00396/2012 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Floxibac 100 mg/ml Solution for Injection for Cattle and Pigs Floxibac vet 100 mg/ml Solution for Injection for Cattle and Pigs (Sweden) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Enrofloxacin 100mg EXCIPIENT: n-butanol 30mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear light yellow solution free from particulate matter. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and Pigs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of bacterial infections caused by strains susceptible to enrofloxacin. Cattle: Respiratory infections caused by _Pasteurella _spp. or _Mycoplasma_ spp. Alimentary tract infections caused by _E. coli_. Pigs: Respiratory infections caused by of _Pasteurella_ spp. or _Mycoplasma_ spp. Alimentary tract infections caused by _E. coli_. Enrofloxacin should be used where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice. 4.3 CONTRAINDICATIONS Do not use for prophylaxis. Do not use when resistance / cross resistance to (Fluoro)quinolones is known to occur. Refer to section 4.5._ _Do not use in the case of known hypersensitivity to fluoroquinolones or to any of the excipients Page 1 of 5 Revised: August 2012 AN: 00396/2012 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None known. 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Do not exceed the recommended dose. Repeat injections should be made at different sites. The safety of the product has not been established in pigs or calves when administered by the intravenous route and use of this route of administration is not recommended in these animal groups. Official and local antimicrobial policies should be taken into account when the product is used. Fluoroquinolones should be reserved for the treatment of clinical cond 阅读完整的文件