PiperacillinTazobactam Kabi 4g0.5g Powder for Solution for Infusion

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

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

Thành phần hoạt chất:

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Sẵn có từ:

FRESENIUS KABI MALAYSIA SDN. BHD

INN (Tên quốc tế):

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Các đơn vị trong gói:

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

Sản xuất bởi:

LABESFAL LABORATORIOS ALMIRO S.A.

Đặc tính sản phẩm

1 (16)
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.
The reconstituted solution is a clear and colourless solution.
PHARMACODYNAMICS
MECHANISM OF ACTION
Piperacillin,
a
broad-spectrum,
semisynthetic
penicillin
exerts
bactericidal
activity
by
inhibition of both septum and cell-wall synthesis.
Tazobactam, a beta-lactam structurally related to penicillins, is an
inhibitor of many beta-
lactamases, which commonly cause resistance to penicillins and
cephalosporins but it does
not inhibit AmpC enzymes or metallo beta-lactamases. Tazobactum
extends the antibiotic
spectrum of piperacillin to include many beta-lactamase-producing
bacteria that have
acquired resistance to piperacillin alone.
PHAMACOKINETIC / PHARMACODYNAMIC RELATIONSHIP
The time above the minimum inhibitory concentration (T>MIC) is
considered to be the major
pharmacodynamic determinant of efficacy for piperacillin.
MECHANISM OF RESISTANCE:
The two main mechanisms of resistance to piperacillin / tazobactam
are:
• Inactivation of the piperacillin component by those
beta-lactamases that are not inhibited
by tazobactam: beta-lactamases in the Molecular class B, C and D. In
addition, tazobactam
does not provide protection against extended-spectrum beta-lactamases
(ESBLs) in the
Molecular class A and D enzyme groups.
• Alteration of penicillin-binding proteins (PBPs), which results in
the reduction of the aff