Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Enrofloxacin
aniMedica GmbH
QJ01MA90
Enrofloxacin
25 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
enrofloxacin
Authorised
2012-04-20
Health Products Regulatory Authority 11 February 2019 CRN008V5C Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Enrotron 25 mg/ml Solution for injection for dogs, cats, rodents, reptiles and ornamental birds 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains: ACTIVE SUBSTANCE Enrofloxacin 25.0 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 Dogs Cats Rodents Reptiles Ornamental birds 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES 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_._ Health Products Regulatory Authority 11 February 2019 CRN008V5C Page 2 of 7 CATS Treatment of infections of the alimentary, respiratory and urogenital tracts (as adjunctive antibiotic therapy for pyometra), skin and wound infections, caused by enrofloxacin susceptible strains of: _Staphylococcus _spp_., Escherichia coli, Pasteurella _ spp_., Klebsiella _spp_., Bordetella _spp_., Pseudomonas _spp_. _and_ Proteus _spp_._ RODENTS, REPTILES AND ORNAMENTAL BIRDS Treatment of infections of the alimentary and respiratory tracts where clinical experience, if possible, supported by susceptibility testing of the causal organism, indicates enrofloxacin as the substance of choice. 4.3 CONTRAINDICATIONS Do not use in dogs less than 1 year of age or in exceptionally large breeds of dog with a longer growth period under 18 months of age. Do not use for cats less than 8 weeks of age. Do not use in cases of known hypersensitivity to fluoroquinolones or to any of the excipients. Do not use Pročitajte cijeli dokument