Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE)
ASTRAZENECA CANADA INC
A10BK01
DAPAGLIFLOZIN
10MG
TABLET
DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) 10MG
ORAL
30
Prescription
Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors
Active ingredient group (AIG) number: 0156370002; AHFS:
APPROVED
2014-12-12
FORXIGA (dapagliflozin propanediol monohydrate) Page 1 of 80 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION FORXIGA ® Dapagliflozin propanediol monohydrate Tablets, 5 mg and 10 mg, Oral ATC Code: A10BK01 Sodium-glucose co-transporter 2 (SGLT2) inhibitors AstraZeneca Canada Inc. 1004 Middlegate Road Mississauga, Ontario L4Y 1M4 www.astrazeneca.ca Date of Initial Authorization: Dec 10, 2014 Date of Revision: Oct 10, 2023 Submission Control Number: 268982 FORXIGA ® is a registered trademark of AstraZeneca AB, used under license by AstraZeneca Canada Inc. FORXIGA (dapagliflozin propanediol monohydrate) Page 2 of 80 RECENT MAJOR LABEL CHANGES 1 INDICATIONS 10/2023 2 CONTRAINDICATIONS 08/2021 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations 08/2021 4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and Dosage Adjustment 10/2023 7 WARNINGS AND PRECAUTIONS 08/2021 7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics 10/2023 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 ............................................................................................................................. 5 2 CONTRAINDICATIONS ............................................................................................................ 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Đọc toàn bộ tài liệu