Marbocare 100 mg/ml Solution for Injection for Cattle and Pigs
Pays: Portugal
Langue: anglais
Source: HMA (Heads of Medicines Agencies)
Résumé des caractéristiques du produit
(SPC)
09-07-2013
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Ingrédients actifs:
marbofloxacin 100 mg/ml
Disponible depuis:
Animalcare Limited
Code ATC:
QJ01MA93
forme pharmaceutique:
Solution for injection
Groupe thérapeutique:
marbofloxacin
Domaine thérapeutique:
Cattle, Pigs
Date de l'autorisation:
2012-09-26
Résumé des caractéristiques du produit
Issued: December 2012
AN: 01043/2011
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbocare 100 mg/ml Solution for Injection for Cattle and Pigs (UK, IE, FR)
Odimar 100 mg/ml Solution for Injection for Cattle and Pigs (BE, NL, LU, ES, PT, DE,
AT)
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
0.1 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, yellowish solution.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle:
Treatment of respiratory infections caused by sensitive strains of _Pasteurella multocida_,
_Mannheimia haemolytica, Histophilus somni_ and _Mycoplasma bovis_
Treatment of acute mastitis caused by _E.coli_ strains sensitive to marbofloxacin during
the lactation period.
In pigs:
Issued: December 2012
AN: 01043/2011
Page 2 of 6
Treatment of Metritis Mastitis Agalactia syndrome (postpartum dysgalactiae syndrome,
PDS) caused by susceptible strains of organisms.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to marbofloxacin or to any other
quinolone 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
Official and local antimicrobial policies should be t
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