CEFTRIAXONE SODIUM FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFTRIAXONE (CEFTRIAXONE SODIUM)

Available from:

TEVA CANADA LIMITED

ATC code:

J01DD04

INN (International Name):

CEFTRIAXONE

Dosage:

1G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CEFTRIAXONE (CEFTRIAXONE SODIUM) 1G

Administration route:

INTRAMUSCULAR

Units in package:

4ML(REGULAR)/2.8ML(LOW VOLUME)

Prescription type:

Prescription

Therapeutic area:

THIRD GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0117292003; AHFS:

Authorization status:

APPROVED

Authorization date:

2006-11-02

Summary of Product characteristics

_PAGE 1 OF 58 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
CEFTRIAXONE SODIUM FOR INJECTION
(STERILE CEFTRIAXONE SODIUM) STERILE POWDER FOR SOLUTION, 1 G AND 10 G CEFTRIAXONE PER VIAL,
INTRAVENOUS OR INTRAMUSCULAR
BP
ANTIBIOTIC
TEVA CANADA LIMITED
30 NOVOPHARM COURT
TORONTO, ONTARIO
M1B 2K9
CONTROL NO: 246728
DATE OF INITIAL
AUTHORIZATION:
NOV. 02, 2006
DATE OF REVISION:
MAY 26, 2021
_PAGE 2 OF 58 _
RECENT MAJOR LABEL CHANGES
WARNINGS AND PRECAUTIONS 04/2020
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
Table of Contents
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
..........................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................
4
1.
INDICATIONS...............................................................................................................
4
1.1
PEDIATRICS.....................................................................................................................
5
1.2 GERIATRICS
.....................................................................................................................
5
2.
CONTRAINDICATIONS
................................................................................................
5
4.
DOSAGE AND ADMINISTRATION
...............................................................................
5
4.1 DOSING CONSIDERATIONS
................................................................................................
5
4.2 RECOMMENDED DOSE AND DOSAGE
ADJUSTMENT............................................................
5
4.3 RECONSTITUTION
..............................................................................................................
7
4.4
ADMINISTRATION..................................................................................