Marboxidin 80 mg Chewable Tablets for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Marbofloxacin

Available from:

Lavet Pharmaceuticals Ltd

ATC code:

QJ01MA93

INN (International Name):

Marbofloxacin

Pharmaceutical form:

Chewable tablet

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Antimicrobial

Authorization status:

Expired

Authorization date:

2013-03-08

Summary of Product characteristics

Issued: March 2013
AN: 00452/2012
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Marboflox 80 mg ChewableTablets for Dogs
_(in Czech Republic, Hungary, Poland,)_
Marboxidin 80 mg Chewable Tablets for Dogs
_(in _
_Belgium, _
_France, _
_Germany, _
_Ireland, _
_Luxembourg, _
_Netherlands, _
_Spain, _
_United _
_Kingdom)_
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
Chewable tablet.
Brownish, oval, divisible, centre scored chewable tablets.
The tablets can be divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Marbofloxacin is indicated in the treatment of:

skin and soft tissue infections (skinfold pyoderma, impetigo,
folliculitis, furunculosis,
cellulitis) caused by strains of microorganisms susceptible to
marbofloxacin_;_

urinary tract infections (UTI) associated or not with prostatitis or
epididymitis caused
by strains of microorganisms susceptible to marbofloxacin _;_

respiratory
tract
infections
caused
by
strains
of
microorganisms
susceptible
to
marbofloxacin_._
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
animals
with
known
hypersensitivity
to
marbofloxacin
or
other
(fluoro)quinolones.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
A low urinary pH could have an inhibitory effect on the activity of
marbofloxacin.
Issued: March 2013
AN: 00452/2012
Page 2 of 4
4.5
SPECIAL PRECAUTIONS FOR USE
(I) 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.
The fluoroquinolones at high doses may have an epileptogenic