CEFTRIAXONE FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Available from:

FRESENIUS KABI CANADA LTD

ATC code:

J01DD04

INN (International Name):

CEFTRIAXONE

Dosage:

2G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 2G

Administration route:

INTRAMUSCULAR

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

THIRD GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0117292006; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-04-07

Summary of Product characteristics

Ceftriaxone for Injection – Product Monograph_ _Page 1 of 58
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
CEFTRIAXONE FOR INJECTION
Sterile Powder for Solution, 250 mg, 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. Date of Initial Authorization:
165 Galaxy Blvd. Suite 100 DEC 16, 2006
Toronto, ON M9W 0C8 Date of Revision:
JAN 05, 2022
Submission Control No.: 255106
Ceftriaxone for Injection – Product Monograph_ _Page 2 of 58
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
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................................
4
1
INDICATIONS
......................................................................................................................
4
1.1 Pediatrics
.....................................................................................................................
5
1.2 Geriatrics
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5
2
CONTRAINDICATIONS
..........................................................................................................
5
4
DOSAGE
AND
ADMINISTRATION
...........................................................................................
5
4.1 Dosing Considerations
...................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
................................................................... 6