SOFTIFLOX 80 MG FLAVOURED CHEWABLE TABLETS FOR DOG

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

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12-06-2017

Ingredientes activos:

MARBOFLOXACIN

Disponible desde:

Norbrook Laboratories Limited

Código ATC:

QJ01MA93

Designación común internacional (DCI):

MARBOFLOXACIN

Dosis:

80 mg/tablet

formulario farmacéutico:

Tablets

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Canine

Área terapéutica:

marbofloxacin

indicaciones terapéuticas:

Antibacterial

Estado de Autorización:

Authorised

Fecha de autorización:

2013-03-22

Ficha técnica

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Softiflox 80 mg flavoured chewable tablets for dogs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Chewable Tablet contains:
Active Substance:
Marbofloxacin
80.0 mg
Excipients :
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable Tablet.
Light brown, oval, flat, bevel edged tablet with breakline.
The tablets can be divided into halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dog.
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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