Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ENROFLOXACIN
Bayer Limited
QJ01MA90
250 Milligram
Tablets
Antibacterial
Canine
2011-07-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Baytril Flavour Tablets 250 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 3 PHARMACEUTICAL FORM Tablet. Light brown to brown, slightly marbled, scored tablets for oral administration to dogs. The tablets can be divided into equal halves. 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. Active substance mg per tablet Enrofloxacin 250.0 For a full list of escipients, see section 6.1. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 26/07/2011_ _CRN 7005428_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS Do not exceed the recommended dose. II) SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY 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 O Read the complete document