KEFLORIL 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE AND PIGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
13-02-2016
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Active ingredient:
FLORFENICOL
Available from:
Vetoquinol UK Limited
ATC code:
QJ01BA90
INN (International Name):
FLORFENICOL
Dosage:
300 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine, Porcine
Therapeutic area:
Florfenicol
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2010-09-24
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Kefloril 300 mg/ml Solution for injection for cattle and pigs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Florfenicol…………300 mg
Excipients
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Light yellow to yellow, clear viscous liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs and cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pigs: treatment of acute outbreaks of respiratory disease caused by strains of _Actinobacillus pleuropneumoniae _and
_Pasteurella multocida _susceptible to florfenicol.
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.
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 ingredient or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 29/01/2016_
_CRN 7022635_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Swab the stopper before removing each dose. Use a dry, sterile syringe and needle.
Do not use in piglets of less than 2 kg.
Use of 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) epide
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