Marbocyl 10%WV Solution For Injection

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

Marbofloxacin

Available from:

Gladron Chemicals Sdn Bhd

INN (International Name):

Marbofloxacin

Units in package:

50 ml; 20 ml; 100 ml; 250 ml

Manufactured by:

Vetoquinol

Patient Information leaflet

DATE OF REVISION OF PACKAGE INSERT
June 2016
REGISTRATION NUMBER: MAL20162584HA
FOR ANIMAL TREATMENT ONLY
CONTROLLED MEDICINE - UBAT TERKAWAL
NAME AND ADDRESS OF MANUFACTURER
VETOQUINOL S.A
Magny-Vernois, 70200 Lure, France
NAME AND ADDRESS OF REGISTRATION HOLDER
AGE D'OR SDN BHD
15, Jalan 31/54, Section 31, Kota Kemuning 40460, Shah Alam,
Selangor D.E., Malaysia
444752 0615 J
COMPOSITION
Marbofloxacin. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 100.0mg
Disodium edetate . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . 0.1mg
Thioglycerol
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
1.0mg
Metacresol
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
2.0mg
Excipient. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . QSP 1mL
PRODUCT DESCRIPTION
A yellow greenish/yellow brownish solution for injection in cattle and
swine.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS PROPERTIES:
Marbofloxacin is a synthetic, bactericidal antimicrobial, belonging to
the fluoro-
quinolone group which acts by inhibition of DNA gyrase. It is
effective against a
wide range of Gram positive bacteria (in particular _ Staphylococci_)
and Gram
negative bacteria (_Escherichia coli, Salmonella typhimurium,
Citrobacter freundii,_
_Enterobacter cloacae, Serratia marcescens, Morganella morganii,
Proteus spp,_
_Klebsiella spp, Shigella spp, Pasteurella spp, Haemophilus spp,
Moraxella spp,_
_Pseudomonas spp_) as well as _Mycoplasma spp_.
PHARMACOKINETIC PROPERTIES:
After subcutaneous or intramuscular administration in cattle and
intramuscular
administration in pigs at the recommended dose of 2mg/kg,
marbofloxacin is
readily absorbed and reaches maximal plasma concentrations of
1.5μg/ml
within less than 1 hour. Its bioavailability is close to 100%.
It is weakly bound to plasma proteins (less than 10% in pigs and 30%
in cattle),
extensively distributed and in most tissues (liver, kidney, skin,
lung, bladder,
uterus, digestive tract) it achieves a higher concentration

Summary of Product characteristics

DOSAGE FORM AND PACKAGING AVAILABLE
Packaged in amber type II glass vials of 50mL and 100mL.
Parenteral in the form of injection, liquid.
FURTHER INFORMATION
Any
unused
veterinary
medicinal
product
or
waste
materials derived from such veterinary medicinal products
should
be
disposed
of
in
accordance
with
local
requirements. Manure and slurry containing marbofloxacin
should not be spread on the same area of land in successive
years.
DATE OF REVISION OF PACKAGE INSERT: June 2018.
REGISTRATION NUMBER: MAL20162584HA
FOR ANIMAL TREATMENT ONLY
CONTROLLED MEDICINE - UBAT TERKAWAL
NAME AND ADDRESS OF MANUFACTURER
VETOQUINOL S.A
Magny-Vernois, 70200 Lure, France
NAME AND ADDRESS OF REGISTRATION HOLDER
GLADRON CHEMICALS SDN. BHD.
No.7, Jalan TP7,
UEP Industrial Park,
40400 Shah Alam,
Selangor Darul Ehsan, Malaysia
454257 0817 B
COMPOSITION
Marbofloxacin . . . . . . . . . . . . . . . . . . . . . . . . . . .
100.0mg
Disodium edetate. . . . . . . . . . . . . . . . . . . . . . . . . . .
0.1mg
Thioglycerol . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 1.0mg
Metacresol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . 2.0mg
Excipient . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. QSP 1mL
PRODUCT DESCRIPTION
A yellow greenish/yellow brownish solution for injection in
cattle and swine.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS PROPERTIES:
Marbofloxacin
is
a
synthetic,
bactericidal
antimicrobial,
belonging to the fluoroquinolone group which acts by
inhibition of DNA gyrase. It is effective against a wide range
of Gram positive bacteria (in particular _ Staphylococci_) and
Gram
negative
bacteria
(_Escherichia _
_coli, _
_Salmonella_
_typhimurium, _
_Citrobacter _
_freundii, _
_Enterobacter _
_cloacae,_
_Serratia _
_marcescens, _
_Morganella _
_morganii, _
_Proteus _
_spp,_
_Klebsiella spp, Shigella spp, Pasteurella spp, Haemophilus spp,_
_Moraxella spp, Pseudomonas spp_) as well as _Mycoplasma spp_.
PHARMACOKINETIC PROPERTIES:
After subcutaneous or intramuscular administration in cattle