Country: United Kingdom
Language: English
Source: VMD (Veterinary Medicines Directorate)
Marbofloxacin
CP Pharma Handelsgesellschaft mbH
QJ01MA93
Marbofloxacin
Tablet
POM-V - Prescription Only Medicine – Veterinarian
Dogs
Antimicrobial
Expired
2013-03-27
Revised: September 2014 AN: 00361/2014 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 P, 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 Issued: September 2014 AN: 00361/2014 Page 2 of 6 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. 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 longer growth period. Not suitable for infections resulting from strict anaerobes, yeast or fungi. Do not use in cases of hypersensitivity to fluoroquinolones or any of the excipients of the product. Do not use in case of resistance against quinolones, since (almost) complete cross-resistance exists against and other fluoroquinolones. Do not use Marbotab P 80 mg tablets in cats. For the treatment of this species, a divisible 20 mg tablet is available (Marbotab P 20 mg tablets). 4.4 SPECIAL WARNINGS None. Issued: Read the complete document