Marbim 100 mg/ml Solution for Injection for cattle and pigs

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Marbofloxacin

Disponível em:

Cross Vetpharm Group Limited

Código ATC:

QJ01MA93

DCI (Denominação Comum Internacional):

Marbofloxacin

Dosagem:

100 milligram(s)/millilitre

Forma farmacêutica:

Solution for injection

Tipo de prescrição:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapêutico:

Cattle, Pigs

Área terapêutica:

marbofloxacin

Indicações terapêuticas:

Antibacterial

Status de autorização:

Authorised

Data de autorização:

2016-11-11

Características técnicas

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.
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.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_1_
_1_
_/_