Marbosol 100 mg/ml Solution for Injection for Cattle and Pigs

Summary of Product characteristics

                                Revised: January 2015
AN: 01100/2014
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbosol 100 mg/ml solution for injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains:
Active substance:
Marbofloxacin
100 mg
Excipients:
Metacresol
2 mg
Monothioglycerol
1 mg
For 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, pigs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle:
Treatment of respiratory infections caused by susceptible strains of _
Pasteurella _
_multocida, Mannheimia haemolytica_ and _Histophilus somni._
Treatment of acute mastitis caused by _ Echerichia coli_ strains
susceptible to
marbofloxacin during the lactation period.
Pigs:
Treatment of Metritis Mastitis Agalactia Syndrome (MMA syndrome,
postpartum
dysgalactia
syndrome,
PDS)
caused
by
bacterial
strains
susceptible
to
marbofloxacin.
4.3
CONTRAINDICATIONS
Do not use in case of bacterial infections with resistance to other
fluoroquinolones
(cross resistance).
Do not use in case of hypersensitivity to the active substance or to
any of the
excipients.
Revised: January 2015
AN: 01100/2014
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Efficacy data have shown an insufficient efficacy of the product for
the treatment
of acute mastitis caused by Gram positive strains.
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
fluoro
                                
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