MINT-ONDANSETRON ODT TABLET (ORALLY DISINTEGRATING)

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

ONDANSETRON

Beschikbaar vanaf:

MINT PHARMACEUTICALS INC

ATC-code:

A04AA01

INN (Algemene Internationale Benaming):

ONDANSETRON

Dosering:

4MG

farmaceutische vorm:

TABLET (ORALLY DISINTEGRATING)

Samenstelling:

ONDANSETRON 4MG

Toedieningsweg:

ORAL

Eenheden in pakket:

15G/50G

Prescription-type:

Prescription

Therapeutisch gebied:

5-HT3 RECEPTOR ANTAGONISTS

Product samenvatting:

Active ingredient group (AIG) number: 0131120003; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2019-04-12

Productkenmerken

Product Monograph
MINT-ONDANSETRON ODT (ondansetron)
Page 1 of 37
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-ONDANSETRON ODT
Ondansetron Orally Disintegrating Tablets
orally disintegrating tablets, 4 mg and 8 mg, oral
Mfr. Std.
Antiemetic
(5-HT
3
receptor antagonist)
ATC code A04AA01
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
April 12, 2019
Date of Revision:
June 16, 2022
Submission Control Number: 260425
Product Monograph
MINT-ONDANSETRON ODT (ondansetron)
Page 2 of 37
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, Adults
06/2022
4 DOSAGE AND ADMINISTRATION. 4.2 Recommended Dose
and Dosage Adjustment
06/2022
7 WARNING 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.......................................................................................................
4
4
DOSAGE AND ADMINISTRATION
........................................................................................
5
4.1
Dosing Considerations
.....................................