Country: Italy
Language: English
Source: HMA (Heads of Medicines Agencies)
marbofloxacin 80 mg
Krka d.d.
QJ01MA93
Tablet
marbofloxacin
Dogs
2012-11-21
Issued: March 2013 AN: 01884/2011 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Marfloquin 80 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Marbofloxacin …….80 mg EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets. Light brownish yellow, capsule shaped, biconvex, marble tablets with possible dark and white spots and scored on the both sides. 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. Issued: March 2013 AN: 01884/2011 Page 2 of 6 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES A low urinary pH could have an inhibitory effec Read the complete document