Florfenikel
Country: United Kingdom
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
08-01-2012
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
florfenicol 300 mg/ml
Available from:
KELA ALBORATORIES N.V.
ATC code:
QJ01BA90
Pharmaceutical form:
Solution for injection
Therapeutic group:
florfenicol
Therapeutic area:
Cattle, Pigs
Authorization date:
2011-10-26
Summary of Product characteristics
Issued: February 2012
AN: 00791/2010
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
NL, CZ, FR, DE, IE, IT, PL, BE, BG, CY, GR, HU, LU, PT, RO, SK: FLORFENIKEL 300
mg/ml solution for injection for pigs
ES, DK: KELAFLOR 300 mg/ml solution for injection for pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
ACTIVE SUBSTANCE:
Florfenicol 300 mg
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for Injection.
Clear, light yellow to yellow solution.
4. CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Diseases caused by florfenicol susceptible bacteria.
Pigs: Treatment of acute outbreaks of swine respiratory disease caused by strains of
_Actinobacillus pleuropneumoniae_ and _Pasteurella multocida_ susceptible to florfenicol.
4.3 CONTRAINDICATIONS
Do not use in boars intended for breeding purposes.
Do not use in piglets of less than 2 kg.
Do not administer to animals with known hypersensitivity to florfenicol or to any of the
excipients.
Do not administer intravenously._ _
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5 SPECIAL PRECAUTIONS FOR USE
(i) Special precautions for use in animals
The product should be used in conjunction with susceptibility testing and take into
account official and local antimicrobial policies.
Issued: February 2012
AN: 00791/2010
Page 2 of 4
The stopper must be cleaned before removing each dose. Use a dry, sterile syringe and
nee
Read the complete document
