SOFTIFLOX 20 MG FLAVOURED CHEWABLE TABLETS FOR DOG

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

MARBOFLOXACIN

Available from:

Norbrook Laboratories Limited

ATC code:

QJ01MA93

INN (International Name):

MARBOFLOXACIN

Dosage:

20 mg/tablet

Pharmaceutical form:

Tablets

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Canine

Therapeutic area:

marbofloxacin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2013-03-22

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Softiflox 20 mg flavoured chewable tablets for dogs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Chewable Tablet contains:
Active Substance:
Marbofloxacin
20.0 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
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Marbofloxacin is indicated in dogs 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.
Respiratory infections, caused by susceptible strains of organisms.
4.3 CONTRAINDICATIONS
Do not use in cats.
A 5 mg tablet is available for the treatment of cats.
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
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.
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