FENFLOR 300 MG/ML SOLUTION FOR INJECTION FOR CATTLE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
22-08-2015
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Active ingredient:
FLORFENICOL
Available from:
Krka, d.d., Novo mesto
ATC code:
QJ01BA90
INN (International Name):
FLORFENICOL
Dosage:
300 Mg/Ml
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine
Therapeutic area:
Florfenicol
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2010-09-03
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Fenflor 300 mg/ml solution for injection for cattle
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.
A light yellow to yellow, clear, viscous liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Diseases caused by florfenicol susceptible bacteria.
Treatment and metaphylaxis of respiratory tract infections in cattle due to _Mannheimia haemolytica, Pasteurella_
_multocida _and _Histophilus somni_, where the presence of the disease in the herd has been established.
4.3 CONTRAINDICATIONS
Do not use in adult bulls intended for breeding purposes.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
Do not use in case of resistance to the active substance.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 07/08/2015_
_CRN 7019882_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Swab septum before removing each dose. Use a dry, sterile syringe and needle.
The product should be used in conjunction with susceptibility testing and take into account official and local
antimicrobial policies.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to
florfenicol and may decrease the effectiveness of treatment with other amfenicols, due to the potential for cross
resistance.
Special precautions to be taken by the person adm
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