MAR-ONDANSETRON TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE)

Beschikbaar vanaf:

MARCAN PHARMACEUTICALS INC

ATC-code:

A04AA01

INN (Algemene Internationale Benaming):

ONDANSETRON

Dosering:

8MG

farmaceutische vorm:

TABLET

Samenstelling:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE) 8MG

Toedieningsweg:

ORAL

Eenheden in pakket:

10/30

Prescription-type:

Prescription

Therapeutisch gebied:

5-HT3 RECEPTOR ANTAGONISTS

Product samenvatting:

Active ingredient group (AIG) number: 0131120001; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2011-09-07

Productkenmerken

_ _
_MAR-Ondansetron Product Monograph _
_Page 1 of 35 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MAR-ONDANSETRON
Ondansetron Tablets
Tablets, 4 mg and 8 mg ondansetron (as ondansetron hydrochloride),
oral
USP
Antiemetic
5-HT3 receptor antagonist
ATC code A04AA01
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite #112
Ottawa, Ontario
K2E 1A2
Date of Initial Authorization:
SEP 07, 2011
Date of Revision:
NOV 4, 2022
Submission Control Number: 268151 _ _
_ _
_MAR-Ondansetron Product Monograph _
_Page 2 of 35 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
11/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose
and Dosage Adjustment
11/2022
7 WARNINGS AND PRECAUTIONS, Cardiovascular,
Myocardial Ischemia and Coronary Artery Spasm
11/2022
7 WARNINGS AND PRECAUTIONS, Special Populations,
7.1.1 Pregnant Women
04/2021
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 (<18 years of age)
....................................................................................
4
1.2
Geriatrics (≥65 years of age)
....................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended