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

Country: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

Virkt innihaldsefni:

Marbofloxacin

Fáanlegur frá:

Ceva Animal Health Ltd

ATC númer:

QJ01MA93

INN (Alþjóðlegt nafn):

Marbofloxacin

Lyfjaform:

Solution for injection

Gerð lyfseðils:

POM-V - Prescription Only Medicine – Veterinarian

Meðferðarhópur:

Cattle, Pigs

Lækningarsvæði:

Antimicrobial

Leyfisstaða:

Authorized

Leyfisdagur:

2010-11-10

Vara einkenni

Revised: October 2022
AN: 01669/2022
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbox 100 mg/ml solution for injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Marbofloxacin
.....................................................100.0 mg
For the 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 and pigs (sows).
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
CATTLE:
Therapeutic
treatment
of
respiratory
infections
caused
by
sensitive
strains
of
_Pasteurella multocida_, _Mannheimia haemolytica_ and _Histophilus
somni_.
Therapeutic treatment of acute mastitis caused by _E. coli_ strains
sensitive to
marbofloxacin during the lactation period.
SOWS:
Treatment
of
Metritis
Mastitis
Agalactia
Syndrome
caused
by
bacterial
strains
sensitive to marbofloxacin.
4.3
CONTRAINDICATIONS
Do not use in case of known hypersensitivity to the active substance
or other
(fluoro)quinolones or to any of the excipients.
Do not use in case of confirmed or suspected resistance to
fluoroquinolones (cross
resistance).
4.4
SPECIAL WARNINGS
None.
Revised: October 2022
AN: 01669/2022
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of the product should be based on susceptibility testing and has
to take into
account official and local antimicrobial policies.
It is prudent to reserve the fluoroquinolones for the treatment of
clinical conditions
that have responded poorly, or are expected to respond poorly, to
other classes of
antibiotics.
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.
As the vial cannot be broached more than 45 times, the user should
choose the most
appropriate vial si