MASTERFLOX 40 MG/ML SOLUTION FOR INJECTION FOR PIGS
Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Produktets egenskaber
(SPC)
08-08-2015
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Aktiv bestanddel:
MARBOFLOXACIN
Tilgængelig fra:
FATRO S.p.A.
ATC-kode:
QJ01MA93
INN (International Name):
MARBOFLOXACIN
Dosering:
40 Mg/Ml
Lægemiddelform:
Solution for Injection
Recept type:
POM
Terapeutisk gruppe:
Porcine
Terapeutisk område:
Marbofloxacin
Terapeutiske indikationer:
Antibacterial
Autorisation status:
Authorised
Autorisation dato:
2015-07-24
Produktets egenskaber
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Masterflox 40 mg/ml solution for injection for pigs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for injection.
Clear yellow solution, with no visible particles.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pig (pig for fattening).
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Treatment of respiratory infections caused by strains of _Actinobacillus pleuropneumoniae, Pasteurella multocida,_
_Mycoplasma hyopneumoniae _susceptible to marbofloxacin_._
4.3 CONTRAINDICATIONS
Do not use in cases where the pathogen involved is resistant to marbofloxacin and other (fluoro)quinolones (cross-
resistance).
Do not administer to animals known to be hypersensitive to marbofloxacin, other quinolones, or to any of the
excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
1 ml contains:
ACTIVE SUBSTANCE:
Marbofloxacin
40 mg
EXCIPIENTS:
Disodium edetate
0.1 mg
For a full list of the excipients, see section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 24/07/2015_
_CRN 7021489_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
This product does not contain an antimicrobial preservative.
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 from the instructions given in the SPC may increase the prevalence of bacteria resista
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