METRONIDAZOLE INJECTION USP SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

METRONIDAZOLE

Dostępny od:

PFIZER CANADA ULC

Kod ATC:

J01XD01

INN (International Nazwa):

METRONIDAZOLE

Dawkowanie:

5MG

Forma farmaceutyczna:

SOLUTION

Skład:

METRONIDAZOLE 5MG

Droga podania:

INTRAVENOUS

Sztuk w opakowaniu:

4X100ML

Typ recepty:

Prescription

Dziedzina terapeutyczna:

MISCELLANEOUS ANTIPROTOZOALS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2004-03-05

Charakterystyka produktu

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_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
............................................................................................................
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
............