KEFLORIL
Land: Italien
Sprog: engelsk
Kilde: HMA (Heads of Medicines Agencies)
Produktets egenskaber
(SPC)
13-07-2012
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Aktiv bestanddel:
florfenicol 300 mg/ml
Tilgængelig fra:
Vetoquinol S.A.
ATC-kode:
QJ01BA90
Lægemiddelform:
Solution for injection
Terapeutisk gruppe:
florfenicol
Terapeutisk område:
Cattle, Pigs
Autorisation dato:
2011-10-27
Produktets egenskaber
Kefloril - FR/V/0216/01/DC – Revised SPC – D210
June 2010
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
KEFLORIL 300 mg/ml Solution for injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Florfenicol…………300 mg
EXCIPIENT(S):
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Light yellow to yellow, clear viscous liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs and cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Swine: treatment of acute outbreaks of respiratory disease caused by strains of _Actinobacillus _
_pleuropneumoniae _and_ Pasteurella multocida _susceptible to florfenicol.
Cattle: diseases caused by florfenicol susceptible bacteria.
Preventive and therapeutic treatment of respiratory tract infections in cattle due to _Mannheimia _
_haemolytica, Pasteurella multocida _and_ Histophilus somni_. The presence of the disease in the herd
should be established before preventive treatment.
4.3
CONTRAINDICATIONS
Do not administer to boars and adult bulls intended for breeding purposes.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Swab the stopper before removing each dose. Use a dry, sterile syringe and needle.
Do not use in piglets of less than 2 kg.
Kefloril - FR/V/0216/01/DC – Revised SPC – D210
June 2010
The product should be used in conjunction with susceptibility testing and take into account offi
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