Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: HMA (Heads of Medicines Agencies)
marbofloxacin 80 mg
Ecuphar N.V.
QJ01MA93
Tablet
marbofloxacin
Dogs Non Food
2013-06-26
Issued: July 2013 AN: 00515/2012 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Actimarbo 80 mg Flavoured Tablets for Dogs (AT, CZ, DE, ES, IT, NL, PT, SK, UK) Actimarbo 80 mg Tablets for Dogs (FR) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Marbofloxacin 80.0 mg per tablet EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. Off white to beige brown spotted, capsule shaped uncoated tablet with break line on both sides and embossed “MV” and “80” on either side of break line on one 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 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. Issued: July 2013 AN: 00515/2012 Page 2 of 7 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 Prečítajte si celý dokument