TAZOCIN 4 EF INJECTION

国家: 南非

语言: 英文

来源: South African Health Products Regulatory Authority (SAHPRA)

可用日期:

Pfizer Laboratories (Pty) Ltd

剂量:

See ingredients

药物剂型:

INJECTION

组成:

EACH VIAL CONTAINS PIPERACILLIN SODIUM EQUIVALENTT TO PIPERACILLIN 4 g TAZOBACTAM SODIUM EQUIVALENT TO TAZOBACTAM 500 mg

授权状态:

Registered

授权日期:

1994-06-06

产品特点

Page 1 of 20
APPROVED PACKAGE INSERT
SCHEDULING STATUS:
PROPRIETARY NAME AND DOSAGE FORM:
TAZOCIN
®
4 EF Injection
COMPOSITION:
Piperacillin/Tazobactam is an injectable antibacterial combination
consisting of the semi-synthetic
antibiotic piperacillin sodium and the beta-lactamase inhibitor
tazobactam sodium for intravenous
administration.
Piperacillin sodium is derived from D(-)-

-aminobenzylpenicillin. The chemical name of piperacillin
sodium is sodium
(2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-l-piperazinecarboxamido)-2-phenylaceta-
mido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic
acid.
Tazobactam sodium is a derivative of the penicillin nucleus.
Chemically, tazobactam is a penicillanic acid
sulfone. Its chemical name is sodium (2S-(2

,3ß,5

)]-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-methyl)-4-thia-
1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide.
TAZOCIN 4 EF Injection contains piperacillin sodium equivalent to
piperacillin 4 g and tazobactam sodium
equivalent to tazobactam 500 mg.
PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and Medium Spectrum Antibiotics
S4
Page 2 of 20
PHARMACOLOGICAL ACTION:
Piperacillin, a broad spectrum, semi-synthetic 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 triazolylmethyl penicillanic acid
sulfone, is an inhibitor of many ß-
lactamases, including the plasmid and chromosomally mediated enzymes.
The presence of tazobactam in
the piperacillin/tazobactam formulation enhances and extends the
antibiotic spectrum of piperacillin.
Microbiology
Piperacillin/tazobactam is highly active against
piperacillin-sensitive micro-organisms as well as ß-
lactamase producing, piperacillin-resistant micro-organisms.
Gram-negative bacteria: Most plasmid mediated ß-lactamase producing
and non-producing strains of
_Escherichia coli, Klebsiella_ spp (including _K. oxytoca, K.
pneumoniae_), _Proteus vulgaris, Proteus