RIVA-DAPAGLIFLOZIN TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

DAPAGLIFLOZIN

제공처:

LABORATOIRE RIVA INC.

ATC 코드:

A10BK01

INN (국제 이름):

DAPAGLIFLOZIN

복용량:

5MG

약제 형태:

TABLET

구성:

DAPAGLIFLOZIN 5MG

관리 경로:

ORAL

패키지 단위:

15G/50G

처방전 유형:

Prescription

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2023-05-15

제품 특성 요약

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_RIVA-DAPAGLIFLOZIN (dapagliflozin) _
_Page 1 of 72 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
RIVA-DAPAGLIFLOZIN
Dapagliflozin Tablets
Tablets, 5 mg and 10 mg, Oral
ATC Code: A10BK01
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Date of Initial Authorization:
July 11, 2022
Submission Control Number: 254745
_ _
_RIVA-DAPAGLIFLOZIN (dapagliflozin) _
_Page 2 of 72 _
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
.....................................................................................