METRONIDAZOLE INJECTION, USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METRONIDAZOLE

Available from:

BAXTER CORPORATION

ATC code:

J01XD01

INN (International Name):

METRONIDAZOLE

Dosage:

5MG

Pharmaceutical form:

SOLUTION

Composition:

METRONIDAZOLE 5MG

Administration route:

INTRAVENOUS

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTIPROTOZOALS

Product summary:

Active ingredient group (AIG) number: 0102572002; AHFS:

Authorization status:

APPROVED

Authorization date:

2000-02-01

Summary of Product characteristics

_METRONIDAZOLE INJECTION, USP Product Monograph _
_Page 1 of 33_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
METRONIDAZOLE INJECTION, USP
Metronidazole
Solution, 5 mg/mL and I.V. infusion
USP
Antibacterial-Antiprotozoal
ATC J01XD01
Baxter Corporation
7125 Mississauga Road
Mississauga
Ontario Canada L5N 0C2
Date of Initial Authorization:
DEC 31, 1990
Date of Revision:
SEPT 20, 2022
Submission Control Number: 263478
_METRONIDAZOLE INJECTION, USP Product Monograph _
_Page 2 of 33_
RECENT MAJOR LABEL CHANGES
2 Contraindications
09/2022
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 and Dosage Adjustment
.............................................. 5
4.4
Administration...................................................................................................
6
4.5
Missed
Dose.............................................................