Marbotab P 80 mg Tablets for Dogs

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Marbofloxacin

Saatavilla:

CP Pharma Handelsgesellschaft mbH

ATC-koodi:

QJ01MA93

INN (Kansainvälinen yleisnimi):

Marbofloxacin

Lääkemuoto:

Tablet

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Dogs

Terapeuttinen alue:

Antimicrobial

Valtuutuksen tilan:

Expired

Valtuutus päivämäärä:

2013-03-27

Valmisteyhteenveto

Revised: September 2014
AN: 00361/2014
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbotab P 80 mg tablets for dogs
List of agreed names in the Member States where product is authorized.
Italy,
Germany,
France,
The
Netherlands, Belgium, Hungary
Marbotab P 80 mg tablets for dogs
Denmark
Marbotab P, 80 mg tablets, for dogs
United Kingdom, Ireland, Poland,
Spain, Austria
Marbotab P, 80 mg tablets for dogs
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
Tablet
Beige oblong tablet, white speckled, with breaking notch on both
sides.
The tablets can be divided into halves.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
Issued: September 2014
AN: 00361/2014
Page 2 of 6
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of infections caused by strains of microorganisms
susceptible to
marbofloxacin.

Skin
and
soft
tissue
infections
(skinfold
pyoderma,
impetigo,
folliculitis,
furunculosis, cellulitis);

Urinary tract infections (UTI) associated or not with prostatitis;

Respiratory tract infections.
See section 5.1, Pharmcodynamic 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.
Not suitable for infections resulting from strict anaerobes, yeast or
fungi.
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.
Do not use Marbotab P 80 mg tablets in cats. For the treatment of this
species,
a divisible 20 mg tablet is available (Marbotab P 20 mg tablets).
4.4
SPECIAL WARNINGS
None.
Issued: