Marfloxin 80 mg tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Marbofloxacin

Available from:

Krka, d.d., Novo mesto

ATC code:

QJ01MA93

INN (International Name):

Marbofloxacin

Dosage:

80 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Dogs

Therapeutic area:

marbofloxacin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2013-05-03

Summary of Product characteristics

Health Products Regulatory Authority
12 January 2018
CRN000TND
Page 1 of 6
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marfloxin 80 mg tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Marbofloxacin
80 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
Light brownish yellow, capsule shaped, biconvex, marble tablets with
possible dark
and white spots and scored on the both sides.
The tablets can be divided into halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections caused by strains of microorganisms
susceptible to
marbofloxacin in dogs:
-skin and soft tissue infections (skinfold pyoderma, impetigo,
folliculitis, furunculosis,
cellulitis);
-urinary tract infections (UTI) associated or not with prostatitis or
epididymitis;
-respiratory tract infections.
4.3 CONTRAINDICATIONS
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.
Do not use in cats. For the treatment of this species, a 5 mg tablet
is available.
Do not use in animals with known hypersensitivity to marbofloxacin or
other
(fluoro)quinolones or to any of the excipients of the product.
Health Products Regulatory Authority
12 January 2018
CRN000TND
Page 2 of 6
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
A low urinary pH could have an inhibitory effect on the activity of
marbofloxacin.
Pyoderma occurs mostly secondary to an underlying disease, thus, it is
advisable to
determine the underlying cause and to treat the animal accordingly.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
High doses of some fluoroquinolones may have epileptogenic potential.
Cautious
use is recommended in dogs diagnosed as suffering from epilepsy.
However, at the
therapeutic recommended dosage, no severe side-effects are to be
expected in dogs.
In p