Florfenicol 300 mg/ml Solution for Injection for Cattle and Pigs
Nazione: Irlanda
Lingua: inglese
Fonte: HMA (Heads of Medicines Agencies)
Scheda tecnica
(SPC)
21-03-2012
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Principio attivo:
florfenicol 300 mg
Commercializzato da:
Pfizer Limited
Codice ATC:
QJ01BA90
Forma farmaceutica:
Solution for injection
Gruppo terapeutico:
florfenicol
Area terapeutica:
Cattle Food, Pigs Food
Data dell'autorizzazione:
2011-06-21
Scheda tecnica
Issued: December 2011
AN: 01064/2010
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Colfen 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.
A light yellow to yellow, clear, viscous liquid practically free from particles.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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.
Pigs: treatment of acute outbreaks of respiratory disease caused by strains of
_Actinobacillus pleuropneumoniae _and_ Pasteurella multocida _susceptible to florfenicol.
4.3
CONTRAINDICATIONS
Do not administer to boars and adult bulls intended for breeding purposes.
Do not use in cases of known hypersensitivity to the active substance or to any of the
excipients.
Do not use in cases of known resistance to the active substance.
Issued: December 2011
AN: 01064/2010
Page 2 of 6
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
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