Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Marbofloxacin
Krka, d.d., Novo mesto
QJ01MA93
Marbofloxacin
20 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Dogs
marbofloxacin
Antibacterial
Authorised
2013-05-03
Health Products Regulatory Authority 12 January 2018 CRN000TND Page 1 of 7 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Marfloxin 20 mg tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Marbofloxacin…….20 mg EXCIPIENTS: For the 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. Health Products Regulatory Authority 12 January 2018 CRN000TND Page 2 of 7 Do not use in cases of hypersensitivity to marbofloxacin or other (fluoro)quinolones or to any of the excipients. Do not use in cases of resistance against quinolones, since (almost) complete cross-resistance exists against other fluoroquinolones. 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 treat the animal accordingly. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS High doses of some fluoroquinolones may have epileptogenic potential. Cautious use is recommended in dogs diagnosed Pročitajte cijeli dokument