CEFTRIAXONE FOR INJECTION POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Disponible depuis:

FRESENIUS KABI CANADA LTD

Code ATC:

J01DD04

DCI (Dénomination commune internationale):

CEFTRIAXONE

Dosage:

100G

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 100G

Mode d'administration:

INTRAVENOUS

Unités en paquet:

100G

Type d'ordonnance:

Prescription

Domaine thérapeutique:

THIRD GENERATION CEPHALOSPORINS

Descriptif du produit:

Active ingredient group (AIG) number: 0117292009; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2015-03-06

Résumé des caractéristiques du produit

_Ceftriaxone for Injection – Product Monograph _
_ _
_ Page 1 of 59 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CEFTRIAXONE FOR INJECTION
Sterile Powder for Solution, 500 mg, 1 g, 2 g ceftriaxone (as
ceftriaxone sodium) per vial
Pharmacy Bulk Package 10 g ceftriaxone (as ceftriaxone sodium) per
vial
100 g ceftriaxone (as ceftriaxone sodium) in SmartPak® Pharmacy Bulk
Package
Intravenous or Intramuscular
USP
Antibiotic
Fresenius Kabi Canada Ltd.
165 Galaxy Blvd. Suite 100
Toronto, ON M9W 0C8
Date of Initial Authorization:
DEC 15, 2006
Date of Revision:
MAY 15, 2023
Submission Control No.: 272154
_Ceftriaxone for Injection – Product Monograph _
_ _
_ Page 2 of 59 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, General, Severe Cutaneous Adverse
Reactions
01/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
...............................................................................................
5
4.2
Recommended Dose