APO-DAPAGLIFLOZIN TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

DAPAGLIFLOZIN

Disponibbli minn:

APOTEX INC

Kodiċi ATC:

A10BK01

INN (Isem Internazzjonali):

DAPAGLIFLOZIN

Dożaġġ:

10MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

DAPAGLIFLOZIN 10MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

15G/50G

Tip ta 'preskrizzjoni:

Prescription

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0156370002; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2023-05-16

Karatteristiċi tal-prodott

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