M-DAPAGLIFLOZIN TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DAPAGLIFLOZIN

제공처:

MANTRA PHARMA INC

ATC 코드:

A10BK01

INN (국제 이름):

DAPAGLIFLOZIN

복용량:

10MG

약제 형태:

TABLET

구성:

DAPAGLIFLOZIN 10MG

관리 경로:

ORAL

패키지 단위:

15G/50G

처방전 유형:

Prescription

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2023-05-16

제품 특성 요약

_ _
_M-DAPAGLIFLOZIN (dapagliflozin) _
_Page 1 of 79 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
M-DAPAGLIFLOZIN
Dapagliflozin Tablets
Tablets, 5 mg and 10 mg, Oral
ATC Code: A10BK01
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Mantra Pharma Inc.
1000 Du Lux, Suite 201
Brossard, Quebec
J4Y 0E3
Date of
Initial Authorization:
February 8, 2023
Date of revision:
December 20, 2023
Submission Control Number: 276505
_ _
_M-DAPAGLIFLOZIN (dapagliflozin) _
_Page 2 of 79 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
12/2023
2 CONTRAINDICATIONS
12/2023
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose
and Dosage Adjustment
12/2023
7 WARNINGS AND PRECAUTIONS
12/2023
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
12/2023
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
..................................................................