ZINACEF INJECTION - PWS IM IV 750MG/VIAL POWDER FOR SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

CEFUROXIME SODIUM

Dostupné s:

GLAXOSMITHKLINE INC

ATC kód:

J01DC02

INN (Mezinárodní Name):

CEFUROXIME

Dávkování:

750MG

Léková forma:

POWDER FOR SOLUTION

Složení:

CEFUROXIME SODIUM 750MG

Podání:

INTRAMUSCULAR

Jednotky v balení:

17 ML X 10

Druh předpisu:

Prescription

Terapeutické oblasti:

SECOND GENERATION CEPHALOSPORINS

Přehled produktů:

Active ingredient group (AIG) number: 0113736002; AHFS:

Stav Autorizace:

CANCELLED POST MARKET

Datum autorizace:

2007-11-30

Charakteristika produktu

CONFIDENTIAL
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PRODUCT MONOGRAPH
PR
ZINACEF
® FOR INJECTION
(sterile cefuroxime sodium USP)
THERAPEUTIC CLASSIFICATION
ANTIBIOTIC
GlaxoSmithKline Inc.
7333 Mississauga Rd
Mississauga, Ontario
L5N 6L4
Date of Revision:
August 15, 2007
Control Number:
114395
_©_
_2007 GlaxoSmithKline Inc. All Rights Reserved _
_®_
_ZINACEF is a registered trademark, used under license by
GlaxoSmithKline Inc. _
CONFIDENTIAL
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2
PRODUCT MONOGRAPH
PR
ZINACEF
® FOR INJECTION
(sterile cefuroxime sodium USP)
ANTIBIOTIC
ACTION AND CLINICAL PHARMACOLOGY
_In vitro_ studies demonstrate that the bactericidal action of
cefuroxime results from
inhibition of bacterial cell wall synthesis by inhibiting the
transpeptidase and
carboxypeptidase enzymes.
INDICATIONS AND CLINICAL USE
TREATMENT
ZINACEF
®
(sterile cefuroxime sodium) may be indicated for the treatment of
patients
with infections caused by susceptible strains of designated organisms
in the following
diseases:
_LOWER RESPIRATORY TRACT INFECTIONS _
_ _
Pneumonia caused by _Streptococcus pneumoniae_, _Haemophilus
influenzae_ including
ampicillin-resistant strains, _Klebsiella _species, _Staphylococcus
aureus _including
ampicillin-resistant (but not methicillin-resistant) strains,
_Streptococcus pyogenes_, and
_Escherichia coli_.
CONFIDENTIAL
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_URINARY TRACT INFECTIONS _
Caused by _Escherichia coli_ and _Klebsiella _species.
_SOFT TISSUE INFECTIONS _
Caused by _Staphylococcus aureus_ including ampicillin-resistant (but
not methicillin-
resistant) strains, _Streptococcus pyogenes, Escherichia coli,
Klebsiella _species.
_MENINGITIS _
Caused by _Staphylococcus aureus_ including ampicillin-resistant (but
not methicillin-
resistant) strains, _Streptococcus pneumoniae, Haemophilus influenzae_
and _Neisseria _
_meningitidis_.
_ _
_GONORRHOEA _
Caused by _Neisseria gonorrhoea_ including ampicillin-resistant
strains.
_BO