Country: Írland
Tungumál: enska
Heimild: HMA (Heads of Medicines Agencies)
marbofloxacin 80 mg
CP Pharma Handelsgesellschaft mbH
QJ01MA93
Tablet
marbofloxacin
Dogs
2012-12-21
Issued: March 2013 AN: 01689/2011 Page 1 of 6 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT Marbotab P 80 mg tablets for dogs List of agreed names in the Member States where product is authorized. Italy, Germany, France, The Netherlands, Belgium, Hungary Marbotab P 80 mg tablets for dogs Denmark Marbotab P, 80 mg tablets, for dogs United Kingdom, Ireland, Poland, Spain, Austria Marbotab 80 mg tablets for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: ACTIVE SUBSTANCE: Marbofloxacin 80 mg EXCIPIENTS: For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Beige oblong tablet, white speckled, with breaking notch on both sides. The tablets can be divided into halves. 4. CLINICAL PARTICULARS 4.1 TARGET SPECIES Dogs 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES Treatment of infections caused by strains of microorganisms susceptible to marbofloxacin. Skin and soft tissue infections (skinfold pyoderma, impetigo, folliculitis, furunculosis, cellulitis); Urinary tract infections (UTI) associated or not with prostatitis; Respiratory tract infections. See section 5.1, Pharmcodynamic properties for further information on specific target pathogens. Issued: March 2013 AN: 01689/2011 Page 2 of 6 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 Bonvier and Mastiffs, with a lon Lestu allt skjalið