Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Enrofloxacin
Chanelle Pharmaceuticals Manufacturing Limited
QJ01MA90
Enrofloxacin
100 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Bovine, Porcine
enrofloxacin
Antibacterial
Authorised
2010-07-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Floxibac 100 mg/ml Solution for Injection for Cattle and Pigs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 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 CATTLE Treatment of infections of the 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_ in cattle less than 2 years old. 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 urinary tract caused by enrofloxacin susceptible strains of_ Escherichia coli_. Treatment of post-partum dysgalactiae syndrome, PDS (MMA syndrome) caused by enrofloxacin susceptible strains of _Escherichia coli_ and_ Klebsiella_ 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_. Each ml contains: ACTIVE SUBSTANCE: Enrofloxacin 100 mg EXCIPIENT: n-butanol 30 mg For the full list of excipients, see section 6.1. H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Прочитать полный документ