ACCEL-ONDANSETRON TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE)

Beschikbaar vanaf:

ACCEL PHARMA INC

ATC-code:

A04AA01

INN (Algemene Internationale Benaming):

ONDANSETRON

Dosering:

8MG

farmaceutische vorm:

TABLET

Samenstelling:

ONDANSETRON (ONDANSETRON HYDROCHLORIDE DIHYDRATE) 8MG

Toedieningsweg:

ORAL

Eenheden in pakket:

10

Prescription-type:

Prescription

Therapeutisch gebied:

5-HT3 RECEPTOR ANTAGONISTS

Product samenvatting:

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

Autorisatie-status:

APPROVED

Autorisatie datum:

2018-07-18

Productkenmerken

_Product Monograph _
_Accel-Ondansetron (ondansetron film-coated tablets) _
_Page 1 of 38_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ACCEL-ONDANSETRON
ondansetron film-coated tablets
Tablets, 4 mg and 8 mg ondansetron (as ondansetron hydrochloride
dihydrate), oral
Mfr. Std.
Antiemetic
5-HT
3
receptor antagonist
ATC code A04AA01
Accel Pharma Inc.
119 Labrosse Ave
Pointe-Claire, Quebec
Canada
H9R 1A3
Date of Initial Authorization:
JUL 18, 2018
Date of Revision:
JUN 30, 2022
Submission Control Number: 260565
_Product Monograph _
_Accel-Ondansetron (ondansetron film-coated tablets) _
_Page 2 of 38_
RECENT MAJOR LABEL CHANGES
1
INDICATIONS
06/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
06/2022
7 WARNINGS AND PRECAUTIONS, Cardiovascular, Myocardial
Ischemia and Coronary Artery Spasm
06/2022
7 WARNING AND PRECAUTIONS, Special Populations, 7.1.1 Pregnant
Women
12/2020
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
..................................................................................................
5
4
DOSAGE AND
ADMINISTRATION..................................................................................
5
4.1
Dosing
Considerations.............................................