Fenflor 300 mg/ml Solution for Injection for Pigs
Country: Ireland
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
14-04-2013
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Active ingredient:
florfenicol 30 g
Available from:
Gosmore Ltd
ATC code:
QJ01BA90
Pharmaceutical form:
Solution for injection
Therapeutic group:
florfenicol
Therapeutic area:
Pigs
Authorization date:
2010-04-14
Summary of Product characteristics
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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