FORCYL 160 MG/ML SOLUTION FOR INJECTION FOR CATTLE
Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Produktets egenskaber
(SPC)
04-11-2016
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Aktiv bestanddel:
MARBOFLOXACIN
Tilgængelig fra:
Vetoquinol UK Limited
ATC-kode:
QJ01MA93
INN (International Name):
MARBOFLOXACIN
Dosering:
160 Mg/Ml
Lægemiddelform:
Solution for Injection
Recept type:
POM
Terapeutisk gruppe:
Bovine
Terapeutisk område:
Marbofloxacin
Terapeutiske indikationer:
Antibacterial
Autorisation status:
Authorised
Autorisation dato:
2011-07-22
Produktets egenskaber
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Forcyl 160 mg/ml solution for injection for cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE INGREDIENT(S):
Marbofloxacin............................. 160 mg
EXCIPIENTS:
Benzyl alcohol (E 1519)………………... 15 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear yellow greenish to yellow brownish solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle:
- Therapeutic treatment of respiratory infections caused by sensitive strains of _Pasteurella multocida _and _Mannheimia_
_haemolytica_.
In lactating cows:
- Treatment of acute mastitis caused by sensitive strains of _Escherichia coli._
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to fluoroquinolones 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
The efficacy of the product has not been tested on mastitis caused by Gram positive bacteria.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 20/10/2016_
_CRN 7023454_
_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 this 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. Wherever possible, use of the product should only be
based on susceptibility testing.
Use of the
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