Efex 40 mg chewable tablets for dogs

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Marbofloxacin

Saatavilla:

Ceva Santé Animale

ATC-koodi:

QJ01MA93

INN (Kansainvälinen yleisnimi):

Marbofloxacin

Annos:

40 mg/tablet

Lääkemuoto:

Chewable tablet

Prescription tyyppi:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeuttinen ryhmä:

Dogs

Terapeuttinen alue:

marbofloxacin

Käyttöaiheet:

Antibacterial

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2016-04-22

Valmisteyhteenveto

Health Products Regulatory Authority
06 May 2021
CRN009XNY
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Efex 40 mg chewable tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains:
ACTIVE SUBSTANCE:
Marbofloxacin ............................................... 40.0 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.
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 clinical
conditions which have responded poorly, or