Actimarbo 5 mg Flavoured Tablets for Dogs and Cats
Country: Germany
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
22-08-2013
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Active ingredient:
marbofloxacin 5 mg
Available from:
Ecuphar N.V.
ATC code:
QJ01MA93
Pharmaceutical form:
Tablet
Therapeutic group:
marbofloxacin
Therapeutic area:
Cats Non Food, Dogs Non Food
Authorization date:
2013-06-26
Summary of Product characteristics
Issued: August 2013
AN: 00513/2012
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Actimarbo 5 mg Flavoured Tablets for Dogs and Cats (AT, CZ, DE, ES, IT, NL, PT, SK,
UK)
Actimarbo 5 mg Tablets for Dogs and Cats (FR)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE:
Marbofloxacin
5.0 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Off-white to beige brown spotted, round, uncoated tablet embossed
“MV” and “5” on
either side of break line on one side and plain on other side.
The tablets can be divided into halves.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Dogs and cats.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In dogs
Marbofloxacin is indicated in the treatment of:
Skin and soft tissue infections caused by susceptible strains of organisms.
Urinary tract infections (UTI) associated or not with prostatitis or epididymitis caused
by susceptible strains of organisms.
Respiratory infections, caused by susceptible strains of organisms.
Issued: August 2013
AN: 00513/2012
Page 2 of 8
In cats
Marbofloxacin is indicated in the treatment of skin and soft tissue infections (wounds,
abscesses, phlegmons) and upper respiratory tract infections caused by susceptible
strains of organisms.
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,
Bouvier and M
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