Marfloxin 20 mg tablets for dogs

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Marbofloxacin

Dostępny od:

Krka, d.d., Novo mesto

Kod ATC:

QJ01MA93

INN (International Nazwa):

Marbofloxacin

Dawkowanie:

20 mg/tablet

Forma farmaceutyczna:

Tablet

Typ recepty:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupa terapeutyczna:

Dogs

Dziedzina terapeutyczna:

marbofloxacin

Wskazania:

Antibacterial

Status autoryzacji:

Authorised

Data autoryzacji:

2013-05-03

Charakterystyka produktu

Health Products Regulatory Authority
12 January 2018
CRN000TND
Page 1 of 7
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marfloxin 20 mg tablets for dogs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Marbofloxacin…….20 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
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.
Health Products Regulatory Authority
12 January 2018
CRN000TND
Page 2 of 7
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 fluoroquinolones may have epileptogenic potential.
Cautious
use is recommended in dogs diagnosed