CEFOTAXIME SODIUM FOR INJECTION, BP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFOTAXIME (CEFOTAXIME SODIUM)

Available from:

HOSPIRA HEALTHCARE ULC

ATC code:

J01DD01

INN (International Name):

CEFOTAXIME

Dosage:

2.0G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CEFOTAXIME (CEFOTAXIME SODIUM) 2.0G

Administration route:

INTRAMUSCULAR

Units in package:

6ML/11ML

Prescription type:

Prescription

Therapeutic area:

THIRD GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0114953003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-03-21

Summary of Product characteristics

1
PRODUCT MONOGRAPH
PR
CEFOTAXIME SODIUM FOR INJECTION BP
250 mg, 500 mg, 1 g or 2 g cefotaxime (as cefotaxime sodium) per vial
β- Lactam Antibiotic
Hospira Healthcare Corporation
1111 Dr. Frederik-Philips, Suite 600
Saint-Laurent, QC
H4M 2X6
Control Number: 181282
Date of revision: January 22, 2015
2
PRODUCT MONOGRAPH
PR
CEFOTAXIME SODIUM FOR INJECTION BP
250 mg, 500 mg, 1 g or 2 g cefotaxime (as cefotaxime sodium) per vial
β- Lactam Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
Cefotaxime
Sodium
for
Injection
BP
is
a
semi-synthetic,
2-aminothiazolyl
cephalosporin
antibiotic for parenteral use. _In vitro_ studies indicate that the
antibacterial action of Cefotaxime
Sodium results from inhibition of cell wall synthesis. It is stable
against the action of most β-
lactamases.
INDICATIONS AND CLINICAL USE
TREATMENT
Cefotaxime Sodium for Injection BP may be indicated for the treatment
of infections caused by
susceptible strains of the designated micro-organisms in the diseases
listed below.
LOWER RESPIRATORY TRACT INFECTIONS:
Pneumonia
and
lung
abscess
caused
by
_Streptococcus _
_pneumoniae_
(formerly
_Diplococcus _
_pneumoniae_), other streptococci (excluding enterococci, e.g. _S.
faecalis_), _Staphylococcus aureus_
(penicillinase
and
non-penicillinase
producing),
_Escherichia _
_coli, _
_Hemophilus _
_influenzae_,
(including ampicillin-resistant strains) and unspecified _Klebsiella_
species.
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 gonorrhea caused by _N. gonorrhoeae,_ including
penicillin-resistant strains.
3
BACTEREMIA/SEPTICEMIA:
Caused by _Escherichia coli_, unspecified _Klebsiella_ strains and
_Serratia marcescens_.
SKIN INFECTIONS:
Caused
by
_Staphylococcus _
_aureus_
(penicillinase
and
non-penicillinase
producing),
_S. epidermidis,_ group A streptococci, _ Escherichia coli, Proteus
mirabilis_ and indole pos