UBIFLOX 5 MG TABLETS FOR CATS AND DOGS
Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
Toote omadused
(SPC)
05-06-2015
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Toimeaine:
MARBOFLOXACIN
Saadav alates:
Krka, d.d., Novo mesto
ATC kood:
QJ01MA93
INN (Rahvusvaheline Nimetus):
MARBOFLOXACIN
Annus:
5 Milligram
Ravimvorm:
Tablets
Retsepti tüüp:
POM
Terapeutiline rühm:
Canine, Feline
Terapeutiline ala:
Marbofloxacin
Näidustused:
Antibacterial
Volitamisolek:
Authorised
Loa andmise kuupäev:
2013-05-31
Toote omadused
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Ubiflox 5 mg tablets for cats and dogs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Marbofloxacin………5mg
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
Cats and 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.
In cats:
skin and soft tissue infections (wounds, abscesses, phlegmons);
upper 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 aged less than 16 weeks.
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 treat the animal accordingly.
HEALTH PRODUCTS REGULATORY AUTHORITY
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