MARBOX 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS
Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Vara einkenni
(SPC)
17-10-2015
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Virkt innihaldsefni:
MARBOFLOXACIN
Fáanlegur frá:
Ceva Santé Animale
ATC númer:
QJ01MA93
INN (Alþjóðlegt nafn):
MARBOFLOXACIN
Skammtar:
100 Mg/Ml
Lyfjaform:
Solution for Injection
Gerð lyfseðils:
POM
Meðferðarhópur:
Bovine, Porcine
Lækningarsvæði:
Marbofloxacin
Ábendingar:
Antibacterial
Leyfisstaða:
Authorised
Leyfisdagur:
2010-12-10
Vara einkenni
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbox 100 mg/ml solution for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Marbofloxacin ............................................................ 100.0 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and pigs (sows).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE:
Therapeutic treatment of respiratory infections caused by sensitive strains of _Pasteurella multocida_, _Mannheimia_
_haemolytica _and _Histophilus somni_.
Therapeutic treatment of acute mastitis caused by _E. coli _strains sensitive to marbofloxacin during the lactation period.
SOWS:
Treatment of Metritis Mastitis Agalactia Syndrome caused by bacterial strains sensitive to marbofloxacin.
4.3 CONTRAINDICATIONS
Do not use in case of known hypersensitivity to the active substance or other (fluoro)quinolones or to any of the
excipients.
Do not use in case of confirmed or suspected resistance to fluoroquinolones (cross resistance).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 02/10/2015_
_CRN 7020230_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of the product should be based on susceptibility testing and has to take into account official and local antimicrobial
policies.
It is prudent to reserve the fluoroquinolones for the treatment of clinical conditions that have responded poorly, or are
expected to respond poorly, to other classes of antibiotics
.
Use of the pro
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