Țară: Regatul Unit
Limbă: engleză
Sursă: VMD (Veterinary Medicines Directorate)
Enrofloxacin
Bayer plc
QJ01MA90
Enrofloxacin
Expired
Issued 23/02/2010 – AN 01747/2008 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Baytril Flavour Tablets 250 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 ACTIVE CONSTITUENTS MG PER TABLET Enrofloxacin 250.0 2.2 RELEVANT CONSTITUENTS OF THE EXCIPIENTS Artificial Beef Flavour Irradiated 70.0 For full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Tablet. Light brown to brown, slightly marbled 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 250 mg should not be used for prophylaxis. 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. 1/4 Issued 23/02/2010 – AN 01747/2008 II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS None. III) OTHER PRECAUTIONS None. 4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS) In dogs enrofloxacin may affect articular cartilage during the period of rapid growth. 4.7 USE DURING PREGNANCY, LACTATION OR LAY The product may be used safely in pregnant and lactating animals. 4.8 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known 4.9 AMOUNT(S) TO BE ADMINISTERED AND ADMINISTRATION ROUTE The dosage rate of enrofloxacin is 5 mg/kg given orally once daily or as a divided dose twice Citiți documentul complet