PiperacillinTazobactam Kabi 2g0.25g Powder for Solution for Infusion

国: マレーシア

言語: 英語

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

即購入

ダウンロード 製品の特徴 (SPC)
10-10-2017

有効成分:

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

から入手可能:

FRESENIUS KABI MALAYSIA SDN. BHD

INN(国際名):

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

パッケージ内のユニット:

50ml X 1vial Vials; 50ml X 10vial Vials; 50ml X 1vial Vials; 50ml X 5vial Vials

製:

LABESFAL LABORATORIOS ALMIRO S.A.

製品の特徴

                                PACKAGE
INSERT
-
INSTRUCTIONS
FOR
USE
-
READ
CAREFULLY!
Piperacillin/Tazobactam Fresenius_ _Kabi 2 g/0.25 g powder for
solution for infusion.
Piperacillin/Tazobactam Fresenius_ _Kabi 4 g/0.5 g powder for solution
for infusion.
COMPOSITION
Each vial contains 2 g of piperacillin (as sodium salt) and 0.25 g of
tazobactam (as
sodium salt).
Each vial contains 4 g of piperacillin (as sodium salt) and 0.5 g of
tazobactam (as sodium
salt).
Excipient:
Glacial Acetic acid
One vial of powder for solution for infusion contains 4.9 mmol (112
mg) of sodium
One vial of powder for solution for infusion contains 9.7 mmol (224
mg) of sodium
PHARMACEUTICAL FORM
Powder for solution for infusion.
White to off-white powder.
PHARMACODYNAMICS
Piperacillin, a broad spectrum, semisynthetic penicillin active
against many Gram-positive
and
Gram-negative
aerobic
and
anaerobic
bacteria,
exerts
bactericidal
activity
by
inhibition
of
both
septum
and
cell
wall
synthesis.
Tazobactam,
a
triazolmethyl
penicillanic acid sulphone, is a potent inhibitor of many
beta-lactamases, in particular the
plasmid
mediated
enzymes
which
commonly
cause
resistance
to
penicillins
and
cephalosporins
including
the
third
generation
cephalosporins.
The
presence
of
tazobactam
in
the
piperacillin/tazobactam
formulation
enhances
and
extends
the
antibiotic spectrum of piperacillin to include many beta-lactamase
producing bacteria
normally resistant to it and other beta-lactam antibiotics. Thus
piperacillin/tazobactam
combines the properties of a broad spectrum antibiotic and a
beta-lactamase inhibitor.
Mechanism of resistance:
The presence of tazobactam expands the spectrum of activity of
piperacillin to include
microorganisms that would otherwise, due to the formation of
beta-lactamase, be
resistant to piperacillin and other beta-lactam antibiotics. In vitro
investigation has
demonstrated
that
the
type
I
beta-lactamase
inducing
ability
of
tazobactam
is
insignificant with regard to Gram-negative bacteria.ln vitro studies
have demonstrated a
synergetic effect of piperacilli
                                
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