CEFOTAXIME FOR INJECTION USP POWDER FOR SOLUTION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

CEFOTAXIME (CEFOTAXIME SODIUM)

זמין מ:

NOVOPHARM LIMITED

כמות:

1G

טופס פרצבטיות:

POWDER FOR SOLUTION

הרכב:

CEFOTAXIME (CEFOTAXIME SODIUM) 1G

מסלול נתינה (של תרופות):

INTRAMUSCULAR

יחידות באריזה:

100

סוג מרשם:

Schedule G (CDSA IV)

leaflet_short:

Active ingredient group (AIG) number: 0114953002

מצב אישור:

CANCELLED PRE MARKET

תאריך אישור:

2015-10-16

מאפייני מוצר

PRODUCT MONOGRAPH
CEFOTAXIME FOR INJECTION USP
(CEFOTAXIME SODIUM)
ANTIBIOTIC
Novopharm Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Control No. 141201
Date of Preparation: February 3, 1999
Date of Revision: December 2, 2010
2
PRODUCT MONOGRAPH
CEFOTAXIME FOR INJECTION USP
(CEFOTAXIME SODIUM)
500 MG, 1 G, AND 2 G CEFOTAXIME PER VIAL
THERAPEUTIC CLASSIFICATION
ANTIBIOTIC
ACTION AND CLINICAL PHARMACOLOGY
CEFOTAXIME for Injection USP (cefotaxime sodium) is a third generation
semisynthetic
cephalosporin antibiotic. Cefotaxime exerts its bactericidal action
through the inhibition of
bacterial cell wall synthesis. Cefotaxime is an aminothiazolyl
cephalosporin and contains an
aminothiazolyl-acetyl side chain, with an alpha-syn-methoximino group
at position 7 of the
cephalosporin nucleus. The aminothiazolyl side chain enhances
antibacterial activity, particularly
against Enterobacteriaceae, and the methoximino group imparts
stability against hydrolysis by
many β-lactamases.
INDICATIONS AND CLINICAL USE
TREATMENT
CEFOTAXIME for Injection USP (Cefotaxime sodium) may be indicated for
the treatment of
infections caused by susceptible strains of the designated
microorganisms in the diseases listed
below.
1.
Lower respiratory tract infections such as pneumonia and lung abscess
when caused by
_Streptococcus_
_pneumoniae_
, other streptococci (excluding enterococci, e.g.
_S. faecalis_
),
_Staphylococcus aureus_
(penicillinase and non-penicillinase producing),
_Escherichia coli_
,
_Haemophilus influenzae_
(including ampicillin resistant strains) and unspecified
_Klebsiella_
species.
2.
Urinary tract infections caused by
_Escherichia coli_
, unspecified
_Klebsiella_
species
(including
_K. pneumoniae_
),
_Proteus mirabilis, indole positive Proteus, Serratia_
_marcescens_
and
_Staphylococcus epidermidis_
. Also, uncomplicated gonorrhoea caused by
_N. gonorrhoeae_
including penicillin resistant strains.
3.
Bacteremia/Septicemia caused by
_Escherichia coli_
, unspecified
_Klebsiella_
strains and
_Serratia marcescens_
.
3
4.
Skin in