Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
ENROFLOXACIN
FORTE Healthcare Ltd
QJ01MA90
ENROFLOXACIN
100 Mg/Ml
Solution for Injection
POM
Bovine, Porcine
Enrofloxacin
Antibacterial
Authorised
2012-04-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Enrotron 100 mg/ml Solution for injection for cattle and pigs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE Enrofloxacin 100.0 mg EXCIPIENTS 1-Butanol 30.0 mg For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Solution for injection. Clear, slightly yellowish to yellowish orange solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle Pig 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 acute severe mastitis caused by enrofloxacin susceptible strains of_ Escherichia coli_. 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_. 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _ Lire le document complet