PRO-DAPAGLIFLOZIN TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

DAPAGLIFLOZIN

Mevcut itibaren:

PRO DOC LIMITEE

ATC kodu:

A10BK01

INN (International Adı):

DAPAGLIFLOZIN

Doz:

5MG

Farmasötik formu:

TABLET

Kompozisyon:

DAPAGLIFLOZIN 5MG

Uygulama yolu:

ORAL

Paketteki üniteler:

15G/50G

Reçete türü:

Prescription

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2023-05-16

Ürün özellikleri

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