产品特点
Issued: May 2013
AN: 01887/2011
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ubiflox 20 mg tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Marbofloxacin
…….20 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets.
Light brownish yellow, round, biconvex, marble tablets with bevelled edges and with possible
dark and white spots, scored 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
Treatment of infections caused by strains of microorganisms susceptible to marbofloxacin in
dogs:
skin and soft tissue infections (skinfold pyoderma, impetigo, folliculitis, furunculosis,
cellulitis);
urinary tract infections (UTI) associated or not with prostatitis or epididymitis;
respiratory tract infections.
4.3
CONTRAINDICATIONS
Do not use 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 cats. For the treatment of this species, a 5 mg tablet is available.
Do not use in animals with known hypersensitivity to marbofloxacin or other
(fluoro)quinolones or to any of the excipients of the product.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
A low urinary pH could have an inhibitory effect on the activity of marbofloxacin. Pyoderma
occurs mostly secondary to an underlying disease, thus, it is advisable to determine the
underlying cause and to trea
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