Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Enrofloxacin
Krka d.d., Novo Mesto
QJ01MA90
Enrofloxacin
Solution for injection
POM-V - Prescription Only Medicine – Veterinarian
Cattle, Dogs, Pigs
Antimicrobial
Authorized
2006-03-15
Revised: January 2015 AN: 01130/2014 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT ENROXIL 50 mg/ml solution for injection for calves, pigs and dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution for injection contains: ACTIVE SUBSTANCE: Enrofloxacin 50 mg EXCIPIENT(S): n-butyl alcohol as antimicrobial preservative 30 mg For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear yellow solution practically free from particles 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Calves, pigs, dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Calves: 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_. 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._ Dogs: Treatment of infections of the alimentary, respiratory and urogenital tracts (including prostatitis, adjunctive antibiotic therapy for pyometra), skin and wound infections, otitis (externa/media) caused by enrofloxacin susceptible strains of _Staphylococcus _spp., _Escherichia coli_, _Pasteurella _spp., _Klebsiella _spp., _Bordetella _spp., _Pseudomonas _spp. and _Proteus _spp. Revised: January 2015 AN: 01130/2014 Page 2 of 7 4.3 CONTRAINDICATIONS Do not use for prophylaxis. Do not use in cases of resistance ag Read the complete document