ZINACEF INJECTION - PWS IV 7.5GM/VIAL POWDER FOR SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

CEFUROXIME SODIUM

Доступно од:

GLAXOSMITHKLINE INC

АТЦ код:

J01DC02

INN (Међународно име):

CEFUROXIME

Дозирање:

7.5G

Фармацеутски облик:

POWDER FOR SOLUTION

Састав:

CEFUROXIME SODIUM 7.5G

Пут администрације:

INTRAVENOUS

Јединице у пакету:

77 ML

Тип рецептора:

Prescription

Терапеутска област:

SECOND GENERATION CEPHALOSPORINS

Резиме производа:

Active ingredient group (AIG) number: 0113736003; AHFS:

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2007-07-09

Карактеристике производа

DCTM/043/575/2006-12-19/131-pristine-zinacef.doc
1
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:
December 19, 2006
Control Number:
108749
_©_
_GlaxoSmithKline Inc. _
_®_
_ZINACEF is a registered trademark, used under license by
GlaxoSmithKline Inc. _
DCTM/043/575/2006-12-19/131-pristine-zinacef.doc
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_.
DCTM/043/575/2006-12-19/131-pristine-zinacef.doc
3
_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.
_BONE AND JOINT INFECTIONS _
Caused by _Staphylococcus aureus_ (penicillinase and non-penicillinas