Efex 100 mg Chewable Tablets for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

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Active ingredient:

Marbofloxacin

Available from:

Ceva Animal Health Ltd

ATC code:

QJ01MA93

INN (International Name):

Marbofloxacin

Pharmaceutical form:

Chewable tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2013-08-07

Summary of Product characteristics

                                Revised: September 2022
AN: 01501/2022
Page 1 of 6
SUMMARY OF THE PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Efex 100 mg chewable tablets for dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCE:
Marbofloxacin......................................................100.0
mg
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet
Clover-shaped scored beige tablet. The tablet can be divided into four
equal parts
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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_.
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
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.
Revised: September 2022
AN: 01501/2022
Page 2 of 6
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 dogs and care should be taken to dose accurately especially
in young
animals.
The fluoroquinolones are also known for their potential neurological
side effects.
Cautious use is recommended in dogs diagnosed as suffering from
epilepsy.
Fluoroquinolones should be reserved for the treatment of cl
                                
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