Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
ENROFLOXACIN
Krka, d.d., Novo mesto
QJ01MA90
ENROFLOXACIN
50 mg/tablet
Tablets
POM
Canine
Enrofloxacin
Antibacterial
Authorised
2009-06-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Enrox Flavour 50 mg Tablets for dogs. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Enrofloxacin 50 mg EXCIPIENTS: For the 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 be affected during the period of rapid growth. Do not use in case of hypersensitivity to the active substance or to any of the excipients. Do not use in dogs having seizure disorders, since enrofloxacin may cause CNS stimulation. Do not use for prophylaxis. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Please see point 4.3. HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 29/04/2015_ _CRN 7020561_ _page number: 1_ 4.5 SPECIAL PRECAUTIONS FOR USE i) Special precautions for use in animals Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or Läs hela dokumentet