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

Land: Storbritannien

Sprog: engelsk

Kilde: VMD (Veterinary Medicines Directorate)

Aktiv bestanddel:

Marbofloxacin

Tilgængelig fra:

Cross Vetpharm Group Ltd

ATC-kode:

QJ01MA93

INN (International Name):

Marbofloxacin

Lægemiddelform:

Solution for injection

Recept type:

POM-V - Prescription Only Medicine – Veterinarian

Terapeutisk gruppe:

Cattle, Pigs

Terapeutisk område:

Antimicrobial

Autorisation status:

Authorized

Autorisation dato:

2016-11-01

Produktets egenskaber

Issued: November 2016
AN: 00058/2015
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Marbim 100 mg/ml Solution for Injection for cattle and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Marbofloxacin
100 mg
EXCIPIENTS:
Metacresol
2.0 mg
Monothioglycerol
1.0 mg
Disodium edetate (E 386)
0.1 mg
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
A clear yellow solution, free of any particulate matter.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and pigs (sows)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In Cattle:
Treatment of respiratory infections caused by sensitive strains of
_Pasteurella _
_multocida_, _Mannheimia haemolytica_ and _Mycoplasma bovis_.
Treatment of acute mastitis caused by _E. coli_ strains sensitive to
marbofloxacin
during the lactation period.
In Pigs (sows):
Treatment of Metritis Mastitis Agalactia syndrome (postpartum
dysgalactia syndrome,
PDS) caused by susceptible strains of organisms.
4.3
CONTRAINDICATIONS
Do not use for bacterial infections with resistance to other
fluoroquinolones (cross
resistance).
Do not administer in animals with known hypersensitivity to
marbofloxacin or any
other quinolone or to any of the excipients.
Page 1 of 5
Issued: November 2016
AN: 00058/2015
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The efficacy data showed that the product has insufficient efficacy
for the treatment
of acute forms of mastitis induced by gram positive bacteria.
4.5
SPECIAL PRECAUTIONS FOR USE
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 in