NRA-DAPAGLIFLOZIN TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

DAPAGLIFLOZIN

Disponibbli minn:

NORA PHARMA 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:

2023-05-24

Karatteristiċi tal-prodott

_ _
_Pr_
_NRA-DAPAGLIFLOZIN (Dapagliflozin Tablets, 5 mg and 10 mg) _
_Page 1 of 70 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
P R
NRA-DAPAGLIFLOZIN
Dapagliflozin Tablets
Tablets, 5 mg and 10 mg, Oral
ATC Code: A10BK01
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Nora Pharma Inc.
1565 Lionel-Boulet Blvd.
Varennes, Québec
J3X 1P7
Date of Preparation:
May 24, 2023
Submission Control Number: 275085
_ _
_Pr_
_NRA-DAPAGLIFLOZIN (Dapagliflozin Tablets, 5 mg and 10 mg) _
_Page 2 of 70 _
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
.......................