Marbocyl 2% Solution for Injection

Summary of Product characteristics

                                Revised: June 2011
AN: 00299/2011
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
MARBOCYL 2 % SOLUTION FOR INJECTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Marbofloxacin
2.0 % w/v
Disodium edetate
0.01 % w/v
Thioglycerol
0.05 % w/v
Metacresol
0.2 % w/v
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
- Cattle: pre-ruminants up to 100 kg b.w.
- Pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In cattle and pigs
Indicated in the treatment of respiratory infections caused by
susceptible strains
of organisms.
4.3
CONTRA-INDICATIONS
None
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
Page 1 of 5
Revised: June 2011
AN: 00299/2011
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. Fluoroquinolones should be reserved for the
treatment
of clinical conditions which have responded poorly, or are expected to
respond poorly, to other classes of antimicrobials. Whenever possible,
fluoroquinolones should only be used based on susceptibility testing.
Use
of the product deviating from the instructions given in the SPC may
increase the prevalence of bacteria resistant to the fluoroquinolones
and
may decrease the effectiveness of treatment with other quinolones due
to
the potential for cross resistance.
ii.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
People with known hypersensitivity to fluoroquinolones should avoid
using
this product. Wash hands after use.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
No severe side-effects are to be expected at doses up to 5 times the
recommended dose in cattle and pigs. In particular no lesions of the
articular
joints are encountered.
Subcutaneous injection is well tolerated. Transitory inflammatory
reactions are
sometimes observed at the injection site, but without clinical imp
                                
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