FLORVETOL 300MG/ML SOLUTION FOR INJECTION FOR SWIN
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
06-05-2024
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Active ingredient:
FLORFENICOL
Available from:
Schering Plough Limited
ATC code:
QJ01BA90
Dosage:
300 Mg/Ml
Pharmaceutical form:
Solution for Injection
Therapeutic group:
Antibacterial
Therapeutic area:
Porcine
Authorization date:
2006-02-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Florvetol 300 mg/ml solution for injection for swine.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains
Active ingredient:
Florfenicol
300.00 mg
Excipients:
For full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for Injection.
Clear, light yellow to straw-coloured, somewhat viscous solution, free from foreign matter.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
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 adult boars intended for breeding purposes.
Do not us in the case of a known hypersensitivity to the active substance or to any other ingredients of the product.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/09/2010_
_CRN 7007198_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMAL
Do not use in piglets of less than 2 kg.
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not
possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the
target bacteria.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE MEDICINAL PRODUCT TO ANIMALS
Care should be taken to avoid accidental self-injection.
Do not use the product in known cases of sensitivity to propylene glycol and polyethylene glycols.
OTHER PRECAUTIONS
None.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
C
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