FENFLOR 300MG/ML SOLUTION FOR INJECTION FOR CATTLE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
03-05-2024
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Active ingredient:
FLORFENICOL
Available from:
Gosmore Ltd
ATC code:
QJ01BA90
Dosage:
300 Mg/Ml
Pharmaceutical form:
Solution for Injection
Therapeutic group:
Antibacterial
Therapeutic area:
Bovine
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.
Florfenicol.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
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 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.
See also section 4.7.
Do not use in case of resistance to the active substance.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Each ml contains:
ACTIVE SUBSTANCE
Florfenicol
300 mg
For a full list of excipients, see section 6.1.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 14/10/2010_
_CRN 7006703_
_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.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
Care should be taken to avoid accidental self-injection.
In case of accidental self injection, seek medical advice and show the label to the doctor.
Do no
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