Țară: Germania
Limbă: engleză
Sursă: HMA (Heads of Medicines Agencies)
marbofloxacin 20 mg
Krka d.d.
QJ01MA93
Tablet
marbofloxacin
Dogs
2012-11-21
Issued: May 2013 AN: 01887/2011 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Ubiflox 20 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Marbofloxacin …….20 mg EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. Light brownish yellow, round, biconvex, marble tablets with bevelled edges and with possible dark and white spots, scored on one side. The tablets can be divided into halves. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of infections caused by strains of microorganisms susceptible to marbofloxacin in dogs: skin and soft tissue infections (skinfold pyoderma, impetigo, folliculitis, furunculosis, cellulitis); urinary tract infections (UTI) associated or not with prostatitis or epididymitis; respiratory tract infections. 4.3 CONTRAINDICATIONS Do not use in dogs aged less than 12 months, or less than 18 months for exceptionally large breeds of dogs, such as Great Danes, Briard, Bernese, Bouvier and Mastiffs, with a longer growth period. Do not use in cats. For the treatment of this species, a 5 mg tablet is available. Do not use in animals with known hypersensitivity to marbofloxacin or other (fluoro)quinolones or to any of the excipients of the product. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES A low urinary pH could have an inhibitory effect on the activity of marbofloxacin. Pyoderma occurs mostly secondary to an underlying disease, thus, it is advisable to determine the underlying cause and to trea Citiți documentul complet