Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Marbofloxacin
Emdoka
QJ01MA93
Marbofloxacin
80 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Canine
marbofloxacin
Antibacterial
Authorised
2013-09-20
Health Products Regulatory Authority 07 August 2018 CRN000X0W Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Marbocare flavour 80 mg tablets for dogs 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EACH TABLET CONTAINS: ACTIVE SUBSTANCE: Marbofloxacin 80.0 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Beige brown spotted oblong tablets, deep score line upper side, score line lower side. The tablet can be divided into halves. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Marbofloxacin is indicated in the treatment of the following infections caused by susceptible strains of organisms (See section 5.1); 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. Health Products Regulatory Authority 07 August 2018 CRN000X0W Page 2 of 6 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. Do not use in cases of confirmed or suspected resistance to fluoroquinolones (cross resistance). 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES A low urinary pH could have an inhibitory effect on the activity of marbofloxacin. 4.5 SPECIAL PRECAUTIONS FOR USE SPECIAL PRECAUTIONS FOR USE IN ANIMALS The fluoroquinolones have been shown to induce erosion of articular cartilage in juvenile dogs and care should be taken to dose accurately especially in young animals. However at the therapeutic recommended dosage, no severe side-effects are to be expected in d Read the complete document