Efex 10 mg chewable tablets for cats and dogs

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Marbofloxacin

Disponible desde:

Ceva Santé Animale

Código ATC:

QJ01MA93

Designación común internacional (DCI):

Marbofloxacin

Dosis:

10 mg/tablet

formulario farmacéutico:

Chewable tablet

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Cats, Dogs

Área terapéutica:

marbofloxacin

indicaciones terapéuticas:

Antibacterial

Estado de Autorización:

Authorised

Fecha de autorización:

2016-04-22

Ficha técnica

Health Products Regulatory Authority
17 May 2018
CRN000W0N
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Efex 10 mg chewable tablets for cats and dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCE:
Marbofloxacin...........................................................
10.0 mg
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Chewable tablet
Oblong scored beige tablet. The tablet can be divided in two equal
parts.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats and Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cats

Marbofloxacin is indicated in the treatment of:
o
skin and soft tissue infections (wounds, abscesses, phlegmons) caused
bysusceptible strains of organisms.

upper respiratory tract infections caused susceptible strains of
organisms.
In dogs
Marbofloxacin is indicated in the treatment of:
- skin and soft tissue infections (skinfold pyoderma, impetigo,
folliculitis, furunculosis,
cellulitis) caused by susceptible strains oforganisms.
- urinary tract infections (UTI) caused by susceptible strains of
organisms associated
Health Products Regulatory Authority
17 May 2018
CRN000W0N
Page 2 of 7
or not with prostatitis or epididymitis.
- respiratory tract infections caused by susceptible strains of
organisms.
4.3 CONTRAINDICATIONS
Do not use in dogs aged less than 12 months, or less than 18 months
for giant
breeds of dogs with a longer growth period. Do not use in cats aged
less than 16
weeks.
Do not use in cases of hypersensitivity to the active substance, other
(fluoro)quinolones or any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
A low urinary pH could have an inhibitory effect on the activity of
marbofloxacin.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
The chewable tablets are flavoured. In order to avoid any accidental
ingestion, store
tablets out of reach of the animals.
The fluoroquinolones have been shown to induce erosi