Marbocyl Solo 10% Solution for Injection for Cattle

País: Regne Unit

Idioma: anglès

Font: VMD (Veterinary Medicines Directorate)

ingredients actius:

Marbofloxacin

Disponible des:

Vetoquinol UK Ltd

Codi ATC:

QJ01MA93

Designació comuna internacional (DCI):

Marbofloxacin

formulario farmacéutico:

Solution for injection

tipo de receta:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapéutico:

Cattle

Área terapéutica:

Antimicrobial

Estat d'Autorització:

Expired

Data d'autorització:

2007-03-14

Fitxa tècnica

Revised: May 2011
AN: 00848/2010
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
The UK, Ireland,
Marbocyl Solo 10% solution for injection for
cattle
Spain
Marbocyl Bovinos 100 mg/ml solution for
injection for cattle
Germany,
Austria,
The
Netherlands,
Belgium,
Italy,
Poland,
Portugal,
The
Slovak Republic, The Czech Republic,
Greece, Luxembourg, France
Marbocyl S 10% solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance :
Marbofloxacin .............100.0 mg
Excipients :
Disodium edetate............0.1 mg
Thioglycerol ...................1.0 mg
metacresol .....................2.0 mg
For a full list of excipients, see section 6.1.”
3.
PHARMACEUTICAL FORM
Solution for injection.
Yellow greenish to yellow brownish, clear solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Therapeutic treatment of respiratory infections caused by sensitive
strains of
_Pasteurella multocida_, _Mannheimia haemolytica_ and _Histophilus
somni_.
4.3
CONTRA-INDICATIONS
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 WARNING FOR EACH TARGET SPECIES
None
Revised: May 2011
AN: 00848/2010
Page 2 of 4
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
poten