Nchi: Hungaria
Lugha: Kiingereza
Chanzo: HMA (Heads of Medicines Agencies)
enrofloxacin 15 mg
Novartis Animal Health UK Limited
QJ01MA90
Tablet
enrofloxacin
Cats, Dogs
2012-01-03
Page 1 of 7 Zobuxa SmPC 100mg tablet dogs clean version_20120130 SUMMARY OF PRODUCT CHARACTERISTICS Page 2 of 7 Zobuxa SmPC 100mg tablet dogs clean version_20120130 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Zobuxa 100 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains: ACTIVE SUBSTANCE(S): Enrofloxacin 100 mg EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Beige-coloured, round, slightly dotted tablet with score line on both sides. 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 Treatment of bacterial infections of the alimentary, respiratory and urogenital tracts, skin, wound infections and otitis externa. 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 that have 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 with tetracyclines, phenicols or macrolides because of potential antagonistic effects. Pregnant and lactating animals, please see section 4.7. Do not use for prophylaxis. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Page 3 of 7 Zobuxa SmPC 100mg tablet dogs clean version_20120130 None. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS It is prudent to r Soma hati kamili