CEFUROXIME FOR INJECTION, USP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFUROXIME (CEFUROXIME SODIUM)

Available from:

STERIMAX INC

ATC code:

J01DC02

INN (International Name):

CEFUROXIME

Dosage:

750MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CEFUROXIME (CEFUROXIME SODIUM) 750MG

Administration route:

INTRAVENOUS

Units in package:

10ML

Prescription type:

Prescription

Therapeutic area:

SECOND GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0122448004; AHFS:

Authorization status:

APPROVED

Authorization date:

2014-03-14

Summary of Product characteristics

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Cefuroxime for Injection, USP: Product Monograph_ _
Page 1 of 33
PRODUCT MONOGRAPH
PR
CEFUROXIME FOR INJECTION, USP
750 mg / 10 mL vial
1.5 g / 20 mL vial
7.5 g / 100 mL Pharmacy Bulk Vial
ANTIBIOTIC
SteriMax Inc.
2770 Portland Drive
Oakville, ON
L6H 6R4
Date of Revision:
August 28, 2020
Control No: 242254
_ _
Cefuroxime for Injection, USP - Product Monograph_ _
Page 2 of 33
PRODUCT MONOGRAPH
PR
CEFUROXIME FOR INJECTION, USP
750 mg / 10 mL vial
1.5 g / 20 mL vial
7.5 g / 100 mL Pharmacy Bulk Vial
THERAPEUTIC CLASSIFICATION
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 USES
TREATMENT
Cefuroxime for Injection, USP may be indicated for the treatment of
patients with infections
caused by susceptible strains of the 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. _
_ _
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_, and _Klebsiella
_species.
MENINGITIS:
Caused by _Staphylococcus aureus _including ampicillin-resistant (but
not methicillin-resistant)
strains, _Streptococcus pneumoniae, Haemophilus influenzae_, and
_Neisseria meningitidis_.
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Cefuroxime for Injection, USP: Product Monograph_ _
Page 3 of 33
GONORRHEA:
Caused by _Neisseria gonorrhoeae _including ampicillin-resistant
strains.
BONE AND JOINT INFECTIONS:
Caused by _Staphylococcus aureus _(penicillinase and non-penicillinase
pro