SOFTIFLOX 5 MG FLAVOURED CHEWABLE TABLETS FOR CATS

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

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Vara einkenni Vara einkenni (SPC)
12-06-2017

Virkt innihaldsefni:

MARBOFLOXACIN

Fáanlegur frá:

Norbrook Laboratories Limited

ATC númer:

QJ01MA93

INN (Alþjóðlegt nafn):

MARBOFLOXACIN

Skammtar:

5 mg/tablet

Lyfjaform:

Tablets

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

Canine, Feline

Lækningarsvæði:

marbofloxacin

Ábendingar:

Antibacterial

Leyfisstaða:

Authorised

Leyfisdagur:

2013-03-22

Vara einkenni

                                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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