APO-DAPAGLIFLOZIN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DAPAGLIFLOZIN

Disponible depuis:

APOTEX INC

Code ATC:

A10BK01

DCI (Dénomination commune internationale):

DAPAGLIFLOZIN

Dosage:

5MG

forme pharmaceutique:

TABLET

Composition:

DAPAGLIFLOZIN 5MG

Mode d'administration:

ORAL

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Descriptif du produit:

Active ingredient group (AIG) number: 0156370001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2023-05-16

Résumé des caractéristiques du produit

APO-DAPAGLIFLOZIN (Dapagliflozin)
Page 1 of 79
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-DAPAGLIFLOZIN
Dapagliflozin Tablets
Tablets, 5 mg and 10 mg, Oral
ATC Code: A10BK01
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Canada M9L 1T9
Date of Initial Authorization:
May 5, 2022
Date of Revision:
February 6, 2023
Submission Control Number: 265658
APO-DAPAGLIFLOZIN (Dapagliflozin)
Page 2 of 79
RECENT MAJOR LABEL CHANGES
Not applicable.
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
........................................................................................................................
4
2
CONTRAINDICATIONS
......................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................. 5
4
DOSAGE AND ADMINISTRATION
......................................................................................
5
4.1
Dosing Considerations
...................................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.............................................................. 6
4.5
Missed Dose
.....................................