Fenflor 300 mg/ml Solution for Injection for Pigs
Pays: Italie
Langue: anglais
Source: HMA (Heads of Medicines Agencies)
Résumé des caractéristiques du produit
(SPC)
14-04-2013
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Ingrédients actifs:
florfenicol 30 g
Disponible depuis:
Gosmore Ltd
Code ATC:
QJ01BA90
forme pharmaceutique:
Solution for injection
Groupe thérapeutique:
florfenicol
Domaine thérapeutique:
Pigs
Date de l'autorisation:
2010-04-14
Résumé des caractéristiques du produit
Revised: March 2013
AN: 01142/2012
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fenflor 300 mg/ml solution for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Florfenicol…………300 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
A light yellow to yellow, clear, viscous liquid.
4.
CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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 intended for breeding.
Do not use in case of hypersensitivity to the active substance or to any of the
excipients.
Do not use in the cases of known resistance to the active substance.
4.4
SPECIAL WARNINGS
None
Revised: March 2013
AN: 01142/2012
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Wipe the stopper before removing each dose. Use a dry, sterile syringe
and needle.
Do not use in piglets of less than 2 kg.
The product should be used in conjunction with susceptibility testing and
take into account official and local antimicrobial policies.
Use a suitable draw-off needle or automatic dosing syringe to avoid
excessive puncturing of the closure.
ii.
Special precautions to be taken by the person administeri
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