VAMOCIN 1GM (Vancomycin Hydrochloride Powder for Concentration for Infusion 1gm)

Country: Malaysia

Language: English

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

Active ingredient:

VANCOMYCIN HYDROCHLORIDE

Available from:

AVERROES PHARMACEUTICALS SDN. BHD.

INN (International Name):

VANCOMYCIN HYDROCHLORIDE

Units in package:

20 ml x 1 Vials

Manufactured by:

Gufic Biosciences Limited, Unit-2

Summary of Product characteristics

VAMOCIN 1GM (VANCOMYCIN HYDROCHLORIDE POWDER FOR CONCENTRATION FOR
INFUSION 1GM)
COMPOSITION:
Linerarity/ non-linearity
Each vial contains:
Vancomycin concentration generally increases proportionally with
increasing dose.
Active Ingredient:
Plasma concentrations during multiple dose administration are similar
to those after
the administration of a singledose.
Vancomycin Hydrochloride EP equivalent to Vancomycin…………1 gm
Characteristics in specific groups
DOSAGE FORM:
_Renal impairment_
_ _
Powder for Solution for Infusion (lyophilised powder)
Vancomycin is primarily cleared by glomerular filtration. In patients
with impaired renal
PRODUCT DESCRIPTION:
function the terminal elimination half- life of vancomycin is
prolonged and the total
A white or off white lyophilised powder.
body clearance is reduced. Subsequently, optimal dose should be
calculated in line
with dosing recommendations provided in section Recommended Dose.
From a microbiological point of view, the product should be used
immediately. If not
_Hepatic impairment_
_ _
used immediately, in-use
storage
times
and
conditions
prior
to
use
are
the
responsibility of
the user and would normally not be longer than 24 hours at
2 - 8
Vancomycin pharmacokinetics is not altered in patients with hepatic
impairment.
degree celcius, unless reconstitution has taken place in controlled
and validated
_Pregnant Women_
_ _
aseptic conditions
_Appearance of reconstituted solution: _
Significantly increased doses may be required to achieve therapeutic
serum
concentrations in pregnant women (see Section Pregnancy and
Lactation).
Clear transparent solution and free of visible particles.
_Overweight patients_
_ _
PHARMACODYNAMICS:
Vancomycin distribution may be altered in overweight patients due to
increases in
MECHANISM OF ACTION
volume of distribution, in renal clearance and possible changes in
plasma protein
Vancomycin is a tricyclic glycopeptide antibiotic that inhibits the
synthesis of the cell
binding. In these subpopulations vancomycin serum concentration were
fo