国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Enrofloxacin
Chanelle Pharmaceuticals Manufacturing Limited
QJ01MA90
Enrofloxacin
50 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Bovine, Canine, Feline, Porcine
enrofloxacin
Antibacterial
Authorised
2010-07-16
2 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Floxibac 50 mg/ml Solution for Injection for Cattle, Pigs, Dogs and Cats 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE: Enrofloxacin 50 mg EXCIPIENT: QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER CONSTITUENTS_ _ QUANTITATIVE COMPOSITION IF THAT INFORMATION IS ESSENTIAL FOR PROPER ADMINISTRATION OF THE VETERINARY MEDICINAL PRODUC t _ _ n-butanol _ _ 30 mg Potassium hydroxide, (for pH adjustment) _ _ _ _ Water for injections _ _ _ _ Clear light yellow solution for injection free from particulate matter. 3. CLINICAL INFORMATION 3.1 TARGET SPECIES Cattle (calves), Pigs, Dogs and Cats. 3.2 INDICATIONS FOR USE FOR EACH TARGET SPECIES Calves: Treatment of infections of respiratory tract caused by enrofloxacin susceptible strains of _Pasteurella _ _multocida, Mannheimia haemolytica _ and _ Mycoplasma _ spp. Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of _Escherichia_ _coli_ . Treatment of septicaemia caused by enrofloxacin susceptible strains of _Escherichia_ _coli_ . Treatment of acute mycoplasma-associated arthritis due to enrofloxacin susceptible strains of _Mycoplasma bovis. _ Pigs: Treatment of infections of the respiratory tract caused by enrofloxacin susceptible strains of _Pasteurella multocida, Mycoplasma _ spp. and _Actinobacillus_ _pleuropneumoniae. _ Treatment of infections of the alimentary tract caused by enrofloxacin susceptible strains of _Escherichia coli. _ Treatment of septicaemia caused by enrofloxacin susceptible strains of _Escherichia_ _coli_ . 3 Dogs: Treatment of infections of the alimentary, respiratory and urogenital tracts (including prostatitis, adjunctive antibiotic therapy for pyometra), skin and wound infections and otitis (externa/media) caused by enrofloxacin susceptible strains of _Staphylococcus _ spp., _Escherichia coli, Pasteurella _ spp., _Klebsiella _ spp., _Bordetella _ spp., _Pseudomonas _ spp. and _Proteus _ spp. Cats: Treatment of infections of the ali 阅读完整的文件