Actimarbo 100 mg/ml, Solution for Injection for Cattle and Pigs
Country: Netherlands
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
21-08-2013
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Active ingredient:
marbofloxacin 100 mg/ml
Available from:
Ecuphar N.V.
ATC code:
QJ01MA93
Pharmaceutical form:
Solution for injection
Therapeutic group:
marbofloxacin
Therapeutic area:
Cattle Food, Pigs Food
Authorization date:
2013-04-24
Summary of Product characteristics
Issued: August 2013
AN: 00146/2012
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Actimarbo 100 mg/ml Solution for Injection for Cattle and Pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Marbofloxacin
100.0 mg
EXCIPIENTS:
Metacresol
2.0 mg
Monothioglycerol
1.0 mg
Disodium edetate (E 386) 0.1 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
A clear pale yellow to greenish
–brownish yellow aqueous solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle & pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle:
Treatment of respiratory infections caused by susceptible strains of
_Pasteurella multocida_, _Mannheimia haemolytica_ and _Histophilus somni_.
Treatment of acute mastitis caused by _Escherichia coli_ strains susceptible to
marbofloxacin during lactation._ _
In pigs:
Treatment of Metritis Mastitis Agalactia syndrome caused by susceptible
strains of organisms.
Issued: August 2013
AN: 00146/2012
Page 2 of 7
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to marbofloxacin, or any
quinolones, or to any of the excipients.
Do not use in cases where the pathogen involved is resistant to other
fluoroquinolones (cross resistance)._ _
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not use in case of conf
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