País: Francia
Idioma: inglés
Fuente: HMA (Heads of Medicines Agencies)
enrofloxacin 50 mg
Krka d.d.
QJ01MA90
Tablet
enrofloxacin
Cats, Dogs
2009-10-12
Revised: December 2009 AN: 01103/2009 SUMMARY OF PTODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Enroxil Flavour 50 mg Tablets for dogs Enrox Flavour 50 mg Tablets for dogs (United Kingdom, Austria, Belgium, Germany, Denmark, Greece, Ireland, Italy, Luxembourg, Netherlands) Enrox Sabor 50 mg Tablets for dogs (Spain, Portugal) Enroxil Flavour 50 mg Tablets for dogs (Bulgaria, Czech Republic, Hungary, Lithuania, Latvia, Poland, Romania, Slovenia, Slovakia) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: Each tablet contains: Enrofloxacin 50 mg EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Round slightly biconvex, cream to light brownish tablets with possible visible white or darker spots, one side scored and bevel-edged. 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 for 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 Do not use in dogs less than 1 year of age or in exceptionally large breeds of dog with a longer growth period less than 18 months of age, as articular cartilage may Leer el documento completo