SOFTIFLOX 5 MG FLAVOURED CHEWABLE TABLETS FOR CATS

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

MARBOFLOXACIN

Disponibil de la:

Norbrook Laboratories Limited

Codul ATC:

QJ01MA93

INN (nume internaţional):

MARBOFLOXACIN

Dozare:

5 mg/tablet

Forma farmaceutică:

Tablets

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupul Terapeutică:

Canine, Feline

Zonă Terapeutică:

marbofloxacin

Indicații terapeutice:

Antibacterial

Statutul autorizaţiei:

Authorised

Data de autorizare:

2013-03-22

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Softiflox 5 mg flavoured chewable tablets for cats and dogs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Chewable Tablet contains:
Active Substance:
Marbofloxacin
5.0 mg
Excipients :
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable Tablet.
Light brown round convex tablet with breakline.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats and dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In dogs:
Indicated for
the treatment
of
skin and soft
tissue infections (skinfold pyoderma,
impetigo,
folliculitis,
furunculosis,
cellulitis)
caused by susceptible strains of
organisms,
urinary tract
infections associated or
not
with
prostatitis caused by susceptible strains of
organisms and respiratory infections,
caused by susceptible strains of
organisms.
In cats:
Indicated for
the treatment
of
skin and soft
tissue infections (wounds,
abscesses phlegmons)
and upper
respiratory tract infections caused by susceptible strains of
organisms.
4.3 CONTRAINDICATIONS
Do not
use in animals with known hypersensitivity to marbofloxacin or
other (fluoro)quinolones or to any of the
excipients.
Do not use in dogs and cats with central nervous system (CNS)
disorders, such as epilepsy, as fluoroquinolones could
potentially cause seizures in predisposed animals
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 as the fluoroquinolones have been
shown to induce erosion of the articular cartilage in juvenile dogs.
Not recommended for use in cats aged less than 16
weeks.
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