METRONIDAZOLE INJECTION USP SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

METRONIDAZOLE

Available from:

PFIZER CANADA ULC

ATC code:

J01XD01

INN (International Name):

METRONIDAZOLE

Dosage:

5MG

Pharmaceutical form:

SOLUTION

Composition:

METRONIDAZOLE 5MG

Administration route:

INTRAVENOUS

Units in package:

4X100ML

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANTIPROTOZOALS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2004-03-05

Summary of Product characteristics

_Pr_
_METRONIDAZOLE INJECTION USP – Product Monograph_
_ _
_Page 1 of 32_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
METRONIDAZOLE INJECTION USP
Metronidazole
Solution, 5 mg / mL and I.V. infusion
USP
Antibacterial-Antiprotozoal
ATC J01XD01
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Initial Authorization:
MAR 10, 1987
Date of Revision:
JUL 04, 2023
Submission Control Number: 272318
_ _
_Pr_
_METRONIDAZOLE INJECTION USP – Product Monograph_
_ _
_Page 2 of 32_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
07/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics
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4
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
........................................................ 5
4.4
Administration
.........................................................................................................
6
4.5
Missed Dose
............