מדינה: פורטוגל
שפה: אנגלית
מקור: HMA (Heads of Medicines Agencies)
marbofloxacin 20 mg
Ecuphar N.V.
QJ01MA93
Tablet
marbofloxacin
Dogs Non Food
2013-06-26
Issued: August 2013 AN: 00514/2012 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Actimarbo 20 mg Flavoured Tablets for Dogs (AT, CZ, DE, ES, IT, NL, PT, SK, UK) Actimarbo 20 mg Tablets for Dogs (FR) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Marbofloxacin 20.0 mg per tablet 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 “20” 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. 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For 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. 4.3 CONTRAINDICATIONS Issued: August 2013 AN: 00514/2012 Page 2 of 7 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 Mastiffs, with a longer growth period. Do not use in animals with known hypersensitivity to marbofloxacin or other (fluoro)quinolones or to any of the excipients of the product. Do not use in case of confirmed or suspected resi קרא את המסמך השלם