Efex 10 mg Chewable Tablets for Cats and Dogs

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

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Produktets egenskaber Produktets egenskaber (SPC)
09-01-2023

Aktiv bestanddel:

Marbofloxacin

Tilgængelig fra:

Ceva Animal Health Ltd

ATC-kode:

QJ01MA93

INN (International Name):

Marbofloxacin

Lægemiddelform:

Chewable tablet

Recept type:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Cats, Dogs

Terapeutisk område:

Antimicrobial

Autorisation status:

Authorized

Autorisation dato:

2013-08-07

Produktets egenskaber

                                Revised: September 2022
AN: 01501/2022
Page 1 of 6
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
by_ _
susceptible 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 of_ _organisms.
- urinary tract infections (UTI) caused by susceptible strains of
organisms associated
or not with prostatitis or epididymitis.
- respiratory tract infections caused by susceptible strains of
organisms.
Revised: September 2022
AN: 01501/2022
Page 2 of 6
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 erosion of articular
cartilage in
juvenile d
                                
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