Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Marbofloxacin
Emdoka
QJ01MA93
Marbofloxacin
5 mg/tablet
Tablet
POM: Prescription Only Medicine as defined in relevant national legislation
Canine, Feline
marbofloxacin
Antibacterial
Authorised
2013-09-20
Health Products Regulatory Authority 07 August 2018 CRN000X0W Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Marbocare flavour 5 mg tablets for dogs and cats 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EACH TABLET CONTAINS: ACTIVE SUBSTANCE: Marbofloxacin 5.0 mg EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Beige brown spotted round tablets with a score line on one side. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and Cats 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); 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 CATS Skin and soft tissue infections (wounds, abscesses, phlegmons) Upper respiratory tract infections Health Products Regulatory Authority 07 August 2018 CRN000X0W Page 2 of 7 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 aged less than 16 weeks. 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 a Read the complete document