UBIFLOX 20 MG TABLETS FOR DOGS
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
05-06-2015
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Ingredient activ:
MARBOFLOXACIN
Disponibil de la:
Krka, d.d., Novo mesto
Codul ATC:
QJ01MA93
INN (nume internaţional):
MARBOFLOXACIN
Dozare:
20 Milligram
Forma farmaceutică:
Tablets
Tip de prescriptie medicala:
POM
Grupul Terapeutică:
Canine
Zonă Terapeutică:
Marbofloxacin
Indicații terapeutice:
Antibacterial
Statutul autorizaţiei:
Authorised
Data de autorizare:
2013-05-31
Caracteristicilor produsului
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 treat the animal accordingly.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 21/05/2015_
_CRN 7020715_
_page numb
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