Marbocare 100 mg/ml Solution for Injection for Cattle and Pigs
Land: Østrig
Sprog: engelsk
Kilde: HMA (Heads of Medicines Agencies)
Produktets egenskaber
(SPC)
09-07-2013
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Aktiv bestanddel:
marbofloxacin 100 mg/ml
Tilgængelig fra:
Animalcare Limited
ATC-kode:
QJ01MA93
Lægemiddelform:
Solution for injection
Terapeutisk gruppe:
marbofloxacin
Terapeutisk område:
Cattle, Pigs
Autorisation dato:
2012-09-26
Produktets egenskaber
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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