Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Enrofloxacin
Krka, d.d., Novo mesto
QJ01MA90
Enrofloxacin
100 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Pigs
enrofloxacin
Antibacterial
Authorised
2009-07-10
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Enroxil 100 mg/ml solution for injection for cattle and pigs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Solution for injection. Clear yellow solution practically free from particles. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle, 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 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_. 1 ml of solution for injection contains: ACTIVE SUBSTANCE: Enrofloxacin 100 mg EXCIPIENT(S): n-butyl alcohol as antimicrobial preservative 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 ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Read the complete document