Shotaflor 300 mg/ml Solution for Injection for Cattle, Florfenicol

Summary of Product characteristics

                                Revised: August 2013
AN: 00534/2012
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Shotaflor 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: August 2013
AN: 00534/2012
Page 2 of 5
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 ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
Care should be taken to avoid accidental self-injection.
In the case of accidental self injection, seek medical advice and show
the label to the
doctor.
Do not use the product in known cases of sensitivity to florfeni
                                
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