Marbosol 20 mg/ml Solution for Injection for Calves and Piglets

Summary of Product characteristics

                                Revised: January 2015
AN. 01099/2014
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbosol 20 mg/ml solution for injection for calves and piglets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ML SOLUTION FOR INJECTION CONTAINS:
Active substance:
Marbofloxacin
20 mg
Excipients:
Metacresol
2 mg
Monothioglycerol
0.50 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 (pre-ruminating calves), piglets
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
PRE-RUMINATING CALVES:
For
treatment
and
prevention
of
respiratory
infections
caused
by
marbofloxacin susceptible _Mannheimia haemolytica_ and _Pasteurella
multocida_
strains, where the presence of the disease has been established in the
group.
PIGLETS:
For
the
treatment
of
respiratory
infections
caused
by
marbofloxacin
susceptible _ Actinobacillus pleuropneumoniae_, Mycoplasma _
hyopneumoniae _
and _Pasteurella multocida_ strains.
4.3
CONTRAINDICATIONS
Do not use in case of bacterial infections with resistance to other
(fluoro)
quinolones (cross resistance).
Do not use in case of hypersensitivity to the active substance or to
any of the
excipients.
Revised: January 2015
AN. 01099/2014
Page 2 of 5
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.
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 f
                                
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