Country: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Marbofloxacin
Krka, d.d., Novo mesto
QJ01MA93
Marbofloxacin
80 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 6 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Marfloxin 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. Health Products Regulatory Authority 12 January 2018 CRN000TND Page 2 of 6 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 as suffering from epilepsy. However, at the therapeutic recommended dosage, no severe side-effects are to be expected in dogs. In p সম্পূর্ণ নথি পড়ুন