Marbiflox 20 mg/ml Solution for Injection for Cattle (Calves) and Pigs

Summary of Product characteristics

                                AN: 01459/2012
Revised April 2013
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbiflox 20 mg/ml solution for injection for cattle (calves) and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains:
ACTIVE SUBSTANCE:
Marbofloxacin 20 mg
EXCIPIENTS:
Metacresol
2 mg
Disodium edetate
0.10 mg
Monothioglycerol
0.50 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, greenish yellow to brownish yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (Calves).
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In pre-ruminant and ruminant calves:
-
treatment of respiratory infections caused by sensitive strains of
_Pasteurella _
_multocida_, _Mannheimia haemolytica_, and _Mycoplasma bovis_.
In pigs:
-
treatment of respiratory infections caused by sensitive strains of
_Actinobacillus pleuropneumoniae_, _Mycoplasma hyopneumoniae_, and
_Pasteurella _
_multocida_.
This product should only be used based on susceptibility testing.
4.3
CONTRAINDICATIONS
Page 1 of 5
AN: 01459/2012
Revised April 2013
Do not use in case of disturbance in growth of cartilage and/or during
injury of
locomotion system particularly on functionally loaded joints.
Do not administer in animals with known hypersensitivity to
marbofloxacin or any
other quinolone or to any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
Official and local antimicrobial policies should be taken into account
when
the product is used.
Fluoroquinolone should be reserved for the treatment of clinical
conditions
which have responded poorly, or are expected to respond poorly, to
other
classes of antimicrobials.
Where possible, fluoroquinolones should be used based on
susceptibility
testing.
Use of the product deviating from instructions given in the SPC may
increase
the prevalence of bacteria resistant to fluoroquinolones and may
decrease
the e
                                
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