Country: France
Language: English
Source: HMA (Heads of Medicines Agencies)
enrofloxacin 150 mg
Sogeval
QJ01MA90
Tablet
enrofloxacin
Dogs
2010-09-30
VETERINARY MEDICINAL PRODUCT XEDEN 150 MG TABLET FOR DOGS PART I B SUMMARY OF PRODUCT CHARACTERISTICS PHARMACEUTICAL FORM TABLET 1. NAME OF THE VETERINARY MEDICINAL PRODUCT XEDEN 150 mg tablet for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ACTIVE SUBSTANCE: One tablet contains: Enrofloxacin .......................................................... 150.0 mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Clover-shaped scored beige tablet The tablet can be divided into four equal parts. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In dogs: - Treatment of lower urinary tract infections (associated or not with prostatitis) and upper urinary tract infections caused by Escherichia Coli or Proteus mirabilis. - Treatment of superficial and deep pyoderma. 4.3 CONTRAINDICATIONS Do not use in young or growing dogs (dogs aged less than 12 months (small breed) or less than 18 months (large breed)) as the product may cause epiphyseal cartilage alterations in growing puppies. Do not use in dogs having seizure disorders, since enrofloxacin may cause CNS stimulation. Do not use in dogs with known hypersensitivity to fluoroquinolones or to any of the excipients of the product. Do not use in the case of resistance to quinolones, as there exists almost complete cross resistance to other quinolones and complete cross resistance to other fluoroquinolones. See also section 4.7 and 4.8. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES None 4.5 SPECIAL PRECAUTIONS FOR USE Read the complete document