Marbokem 100 mg/ml Solution for Injection

Summary of Product characteristics

                                Revised: February 2012
AN: 01636/2011
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbokem 100 mg/ml solution for injection [AT, BE, BG, CY, CZ, DK, EE,
EL,
ES, FR, HU, IE, IT, LT, LU, LV, NL, PL, PT, RO, SK, UK]
MARBOKEM 100 mg/ml solution for injection for cattle [DE]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Marbofloxacin ..........................................100.0 mg
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear yellow solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle.
4.2
INDICATIONS FOR USE,SPECIFYING THE TARGET SPECIES
Treatment of respiratory infections caused by sensitive strains of
_Pasteurella _
_multocida_, _Mannheimia haemolytica_ and _Histophilus somni_.
4.3
CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to fluoroquinolones.
Do not use in cases where the pathogen involved is resistant to other
fluoroquinolones (cross resistance).
4.4
SPECIAL WARNINGS
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.
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.
Revised: February 2012
AN: 01636/2011
Page 2 of 4
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 quinolones should avoid any
contact
with the product.
If the product comes into contact with the skin 
                                
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