CEFUROXIME FOR INJECTION, USP POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CEFUROXIME (CEFUROXIME SODIUM)

Disponible depuis:

FRESENIUS KABI CANADA LTD

Code ATC:

J01DC02

DCI (Dénomination commune internationale):

CEFUROXIME

Dosage:

1.5G

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

CEFUROXIME (CEFUROXIME SODIUM) 1.5G

Mode d'administration:

INTRAVENOUS

Unités en paquet:

50ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

SECOND GENERATION CEPHALOSPORINS

Descriptif du produit:

Active ingredient group (AIG) number: 0122448007; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2006-10-05

Résumé des caractéristiques du produit

Cefuroxime for Injection, USP – Product Monograph Page 1 of 36_ _
PRODUCT MONOGRAPH
PR CEFUROXIME FOR INJECTION, USP
750 mg / 15 mL vials
1.5 g / 50 mL vials
7.5 g / 100 mL Pharmacy Bulk Package Vial
Antibiotic
FRESENIUS KABI CANADA LTD.
Date of Preparation:
165 Galaxy Blvd, Suite 100
April 17, 2020
Toronto, ON M9W 0C8
Control No.: 233970
Cefuroxime for Injection, USP – Product Monograph
Page 2 of 36
PRODUCT MONOGRAPH
PR
CEFUROXIME FOR INJECTION, USP
750 mg / 15 mL vials
1.5 g / 50 mL vials
7.5 g / 100 mL Pharmacy Bulk Package 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_.
GONORRHEA:
Caused by _Neisseria_ _gonorrhoeae_ including ampicillin-resistant
strains.
Cefuroxime for Injection, USP – Product Monograph
Page 3 of 36
BONE AND JOINT INFECTIONS:
Caused by _Staphylococcus aureus_ (p