Marfloxin 5 mg tablets for cats and dogs

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Marbofloxacin

Dostopno od:

Krka, d.d., Novo mesto

Koda artikla:

QJ01MA93

INN (mednarodno ime):

Marbofloxacin

Odmerek:

5 mg/tablet

Farmacevtska oblika:

Tablet

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Cats, Dogs

Terapevtsko območje:

marbofloxacin

Terapevtske indikacije:

Antibacterial

Status dovoljenje:

Authorised

Datum dovoljenje:

2013-05-03

Lastnosti izdelka

Health Products Regulatory Authority
12 January 2018
CRN000TND
Page 1 of 7
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marfloxin 5 mg tablets for cats and dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Marbofloxacin…….5 mg
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
Light brownish yellow, round, biconvex, marble tablets with bevelled
edges and with
possible dark and white spots, scored on one side.
The tablets can be divided into halves.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats and 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.In cats:

skin and soft tissue infections (wounds, abscesses, phlegmons);

upper respiratory tract infections.
Health Products Regulatory Authority
12 January 2018
CRN000TND
Page 2 of 7
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 aged less than 16 weeks.
Do not use in cases of hypersensitivity to marbofloxacin or other
(fluoro)quinolones
or to any of the excipients.
Do not use in cases of resistance against quinolones, since (almost)
complete
cross-resistance exists against other fluoroquinolones.
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 flu