Valsts: Īrija
Valoda: angļu
Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)
Enrofloxacin
Elanco GmbH
QJ01MA90
Enrofloxacin
2.5 percent weight/volume
Oral solution
POM: Prescription Only Medicine as defined in relevant national legislation
enrofloxacin
Authorised
1988-10-01
Health Products Regulatory Authority SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Baytril 2.5% Oral Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Constituents mg/ml Enrofloxacin 25.0 ml Relevant Constituents of the Excipients Benzyl Alcohol 14.0 For a full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Oral solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Calves Exotic Animals (small mammals, reptiles and avian species) 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is for use in calves in the treatment of infections of the alimentary and respiratory tracts of bacterial or mycoplasmal origin (e.g. pasteurellosis, mycoplasmosis, coli-bacilliosis and salmonellosis), where clinical experience supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice. The product may also be used in exotic animals (small mammals, reptiles and avian species) for the treatment of bacterial infections of the alimentary and respiratory tracts where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice. 4.3 CONTRAINDICATIONS The product should not be used for prophylaxis. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES EXOTIC ANIMALS: Consult the Technical Services Department of Bayer prior to use. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS See 4.4 Official and local antimicrobial policies should be taken into account when the product is used. Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials. Whenever possible, fluoroquinoones should only be used based on susceptibility testing. Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with Izlasiet visu dokumentu