产品特点
Forcyl SPC – D210 – July 2012
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Forcyl 160 mg/ml solution for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance:
Marboflo xacin ............................................... 160 mg
Excipients:
Benzyl alcohol
(E 1519)………………... 15 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear yellow greenish to yellow brownish solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle:
- Therapeutic treatment of respiratory infections caused by sensitive strains of _Pasteurella multocida_ and
_Mannheimia haemolytica_.
In lactating cows:
- Treatment of acute mastitis caused by_ _sensitive strains of _Escherichia coli._
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to fluoroquinolones or to any of the excipients.
Do not use in cases where the pathogen involved is resistant to other fluoroquinolones (cross resistance).
4.4
SPECIAL WARNINGS
The efficacy of the product has not been tested on mastitis caused by Gram positive bacteria
.
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Official and local antimicrobial policies should be taken into account when this product is used.
Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are
expected to respond poorly, to other class of a
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