Marbocare flavour 20 mg tablets for dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Marbofloxacin

Available from:

Emdoka

ATC code:

QJ01MA93

INN (International Name):

Marbofloxacin

Dosage:

20 mg/tablet

Pharmaceutical form:

Tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Canine

Therapeutic area:

marbofloxacin

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

2013-09-20

Summary of Product characteristics

Health Products Regulatory Authority
07 August 2018
CRN000X0W
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbocare flavour 20 mg tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH TABLET CONTAINS:
ACTIVE SUBSTANCE:
​
​
Marbofloxacin
​
20.0mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Beige brown spotted round tablets with a cross-snap tab on one side.
The tablet can be divided into halves or quarters.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Marbofloxacin is indicated in the treatment of the following
infections caused by
susceptible strains of organisms (see section 5.1);

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.
Health Products Regulatory Authority
07 August 2018
CRN000X0W
Page 2 of 7
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.
Do not use in cases of confirmed or suspected resistance to
fluoroquinolones (cross
resistance).
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 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. However at the therapeutic recommended dosage, no severe side
effects
are to be expected in dogs.
S