Marfloxin 20 mg tablets for dogs

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Marbofloxacin

Fáanlegur frá:

Krka, d.d., Novo mesto

ATC númer:

QJ01MA93

INN (Alþjóðlegt nafn):

Marbofloxacin

Skammtar:

20 mg/tablet

Lyfjaform:

Tablet

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Meðferðarhópur:

Dogs

Lækningarsvæði:

marbofloxacin

Ábendingar:

Antibacterial

Leyfisstaða:

Authorised

Leyfisdagur:

2013-05-03

Vara einkenni

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