APO-DAPAGLIFLOZIN TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

DAPAGLIFLOZIN

Tilgængelig fra:

APOTEX INC

ATC-kode:

A10BK01

INN (International Name):

DAPAGLIFLOZIN

Dosering:

5MG

Lægemiddelform:

TABLET

Sammensætning:

DAPAGLIFLOZIN 5MG

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Prescription

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2023-05-16

Produktets egenskaber

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
.....................................