Fenflor 300 mg/ml Solution for Injection for Cattle
Country: Spain
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
14-04-2013
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Active ingredient:
florfenicol 300 mg/ml
Available from:
Gosmore Ltd
ATC code:
QJ01BA90
Pharmaceutical form:
Solution for injection
Therapeutic group:
florfenicol
Therapeutic area:
Cattle
Authorization date:
2012-03-02
Summary of Product characteristics
Revised March 2013
AN: 01145/2012
Page 1 of 5
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
Each ml contains:
ACTIVE SUBSTANCE:
Florfenicol
300 mg
For a 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.
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.
Revised March 2013
AN: 01145/2012
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
i.
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.
ii.
Special precautions to be taken by the person
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