MARBIM 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS
Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
Produktens egenskaper
(SPC)
26-11-2016
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Aktiva substanser:
MARBOFLOXACIN
Tillgänglig från:
Cross Vetpharm Group Limited
ATC-kod:
QJ01MA93
INN (International namn):
MARBOFLOXACIN
Dos:
100 Mg/Ml
Läkemedelsform:
Solution for Injection
Receptbelagda typ:
POM
Terapeutisk grupp:
Bovine, Porcine
Terapiområde:
Marbofloxacin
Terapeutiska indikationer:
Antibacterial
Bemyndigande status:
Authorised
Tillstånd datum:
2016-11-11
Produktens egenskaper
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbim 100 mg/ml Solution for Injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Marbofloxacin
100 mg
EXCIPIENTS:
Metacresol
2.0 mg
Monothioglycerol
1.0 mg
Disodium edetate (E 386)
0.1 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection
A clear yellow solution, free of any particulate matter.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and pigs (sows)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In Cattle:
Treatment of respiratory infections caused by sensitive strains of _Pasteurella multocida_, _Mannheimia haemolytica _and
_Mycoplasma bovis_.
Treatment of acute mastitis caused by _E. coli _strains sensitive to marbofloxacin during the lactation period.
In Pigs (sows):
Treatment of Metritis Mastitis Agalactia syndrome (postpartum dysgalactia syndrome, PDS) caused by susceptible
strains of organisms.
4.3 CONTRAINDICATIONS
Do not use for bacterial infections with resistance to other fluoroquinolones (cross resistance).
Do not administer in animals with known hypersensitivity to marbofloxacin or any other quinolone or to any of the
excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The efficacy data showed that the product has insufficient efficacy for the treatment of acute forms of mastitis induced
by gram positive bacteria.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 11/11/2016_
_CRN 7020721_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Official and local antimicrobial policies should be taken into account when the product is used. Fluoroquinolones
should
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