Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
DAPAGLIFLOZIN
APOTEX INC
A10BK01
DAPAGLIFLOZIN
5MG
TABLET
DAPAGLIFLOZIN 5MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0156370001; AHFS:
APPROVED
2023-05-16
APO-DAPAGLIFLOZIN (Dapagliflozin) Page 1 of 79 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR APO-DAPAGLIFLOZIN Dapagliflozin Tablets Tablets, 5 mg and 10 mg, Oral ATC Code: A10BK01 Sodium-glucose co-transporter 2 (SGLT2) inhibitors APOTEX INC. 150 Signet Drive Toronto, Ontario Canada M9L 1T9 Date of Initial Authorization: May 5, 2022 Date of Revision: February 6, 2023 Submission Control Number: 265658 APO-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 ..................................... Prečítajte si celý dokument