MARFLOXIN 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS
Country: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
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(SPC)
05-11-2016
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Virkt innihaldsefni:
MARBOFLOXACIN
Fáanlegur frá:
Krka, d.d., Novo mesto
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:
2011-08-26
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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Marfloxin 100 mg/ml solution for injection for cattle and pigs
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Marbofloxacin
100 mg
EXCIPIENTS:
Disodium edetate
0.10 mg
Monothioglycerol
1 mg
Metacresol
2 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, greenish yellow to brownish yellow 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 _and
_Histophilus somni._
- treatment of acute _E.coli _mastitis_._
In pigs:
- treatment of Metritis Mastitis Agalactia (MMA) syndrome caused by susceptible strains of organisms.
4.3 CONTRAINDICATIONS
Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance).
Do not administer in animals with known hypersensitivity to fluoroquinolones, or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 21/10/2016_
_CRN 7022043_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Official and local antimicrobial policies should be taken into account when the product is used. Fluoroquinolones
should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond
poorly, to other classes of antimicrobials. Whenever possible, fluoroquinolones should only be used based on
susceptibility testing. Use of the product deviating
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