Marbotab 80 mg Tablets for Dogs
Country: Austria
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
28-03-2013
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Active ingredient:
marbofloxacin 80 mg
Available from:
CP Pharma Handelsgesellschaft mbH
ATC code:
QJ01MA93
Pharmaceutical form:
Tablet
Therapeutic group:
marbofloxacin
Therapeutic area:
Dogs
Authorization date:
2012-12-21
Summary of Product characteristics
Issued: March 2013
AN: 01689/2011
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 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
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.
Issued: March 2013
AN: 01689/2011
Page 2 of 6
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 lon
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