PRO-DAPAGLIFLOZIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DAPAGLIFLOZIN

Available from:

PRO DOC LIMITEE

ATC code:

A10BK01

INN (International Name):

DAPAGLIFLOZIN

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

DAPAGLIFLOZIN 10MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2023-05-16

Summary of Product characteristics

Page
PRO-DAPAGLIFLOZIN (Dapagliflozin)
1 of 79
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PRO-DAPAGLIFLOZIN
Dapagliflozin Tablets
Tablets, 5 mg and 10 mg, Oral
ATC Code: A10BK01
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
PRO DOC LTÉE.
2925, boul. Industriel
Laval, Quebec
H7L 3W9
Submission Control Number: 273946
Date of
Initial Authorization:
MAY 03, 2023
PRO-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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
.................................................................................................................
4
1.1
Pediatrics
..........................................................................................................................
4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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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
.............................................................................