Țară: Regatul Unit
Limbă: engleză
Sursă: VMD (Veterinary Medicines Directorate)
Enrofloxacin
Elanco Europe Ltd
QJ01MA90
Enrofloxacin
Tablet
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Antimicrobial
Authorized
1992-05-20
Revised: September 2023 AN: 03529/2022 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Baytril Flavour Tablets 150 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 ACTIVE CONSTITUENTS MG PER TABLET Enrofloxacin 150.0 2.2 RELEVANT CONSTITUENTS OF THE EXCIPIENTS Artificial Beef Flavour Irradiated 42.0 For full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet. Light brown to brown, slightly marbled, round, curved, scored tablets for oral administration to dogs. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES The product is for use in dogs in the treatment of bacterial infections of the alimentary, respiratory and urogenital tracts, skin, secondary wound infections and otitis externa where clinical experience, supported where possible by sensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice. 4.3 CONTRAINDICATIONS Not for 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, as articular cartilage may be affected during the period of rapid growth. Baytril Flavour Tablets 150mg should not be used for prophylaxis. Revised: September 2023 AN: 03529/2022 Page 2 of 6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Please see point 4.3. 4.5 SPECIAL PRECAUTIONS FOR USE i. Special precautions for use in animals Do not exceed the recommended dose. 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, fluoroquinolones should only be used based on susceptibility testing. Use of the product deviating from instructions given in the SPC may increase the prevalence of bacteria resistant to fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance. Official and local antimicrobial policies should be taken Citiți documentul complet