Country: Germany
Language: English
Source: HMA (Heads of Medicines Agencies)
marbofloxacin 5 mg
Ecuphar N.V.
QJ01MA93
Tablet
marbofloxacin
Cats Non Food, Dogs Non Food
2013-06-26
Issued: August 2013 AN: 00513/2012 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Actimarbo 5 mg Flavoured Tablets for Dogs and Cats (AT, CZ, DE, ES, IT, NL, PT, SK, UK) Actimarbo 5 mg Tablets for Dogs and Cats (FR) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Marbofloxacin 5.0 mg EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Off-white to beige brown spotted, round, uncoated tablet embossed “MV” and “5” on either side of break line on one side and plain on other side. The tablets can be divided into halves. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs and cats. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES In dogs Marbofloxacin is indicated in the treatment of: Skin and soft tissue infections caused by susceptible strains of organisms. Urinary tract infections (UTI) associated or not with prostatitis or epididymitis caused by susceptible strains of organisms. Respiratory infections, caused by susceptible strains of organisms. Issued: August 2013 AN: 00513/2012 Page 2 of 8 In cats Marbofloxacin is indicated in the treatment of skin and soft tissue infections (wounds, abscesses, phlegmons) and upper respiratory tract infections caused by susceptible strains of organisms. 4.3 CONTRAINDICATIONS Marbofloxacin should not be used 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 M Read the complete document