Marbotab P 20 mg Tablets for Dogs and Cats

Pays: Royaume-Uni

Langue: anglais

Source: VMD (Veterinary Medicines Directorate)

Ingrédients actifs:

Marbofloxacin

Disponible depuis:

CP Pharma Handelsgesellschaft mbH

Code ATC:

QJ01MA93

DCI (Dénomination commune internationale):

Marbofloxacin

forme pharmaceutique:

Tablet

Type d'ordonnance:

POM-V - Prescription Only Medicine – Veterinarian

Groupe thérapeutique:

Cats, Dogs

Domaine thérapeutique:

Antimicrobial

Statut de autorisation:

Expired

Date de l'autorisation:

2013-03-27

Résumé des caractéristiques du produit

Revised: September 2014
AN: 00361/2014
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbotab P 20 mg tablets for dogs and cats
List of agreed names in the Member States where product is authorized.
Italy,
Germany,
France,
The
Netherlands, Belgium, Hungary
Marbotab P 20 mg tablets for dogs and
cats
Denmark
Marbotab P, 20 mg tablets, for dogs and
cats
United Kingdom, Ireland, Poland,
Spain, Austria
Marbotab P, 20 mg tablets for dogs and
cats
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Marbofloxacin 20 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
Beige tablets with white speckled, cross-snap-tab.
The tablets can be divided into quarters.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs, cats
Revised: September 2014
AN: 00361/2014
Page 2 of 7
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;

Respiratory tract infections.
IN CATS:

Skin and soft tissue infections (wounds, abscesses, phlegmons);

Upper respiratory tract infections.
See section 5.1, Pharmacodynamic properties for further information on
specific
target pathogens.
4.3
CONTRAINDICATIONS
Marbofloxacin should not be used in dogs aged less than 12 months, or
less
than 18 months for exceptionally large breeds of dogs, such as Great
Danes,
Briard, Bernese Bonvier 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 fluoroquinolones or any of
the
excipients of the product.
Do not use in case of resistance against quinolones, since (almost)
complete
cross-resistance exists against and other fluoroquinolones.
Not suitable for infections resulting from strict anaerobes, ye