Страна: Канада
Език: английски
Източник: Health Canada
SITAGLIPTIN (SITAGLIPTIN PHOSPHATE)
ACCORD HEALTHCARE INC
A10BH01
SITAGLIPTIN
25MG
TABLET
SITAGLIPTIN (SITAGLIPTIN PHOSPHATE) 25MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0152414002; AHFS:
APPROVED
2023-01-05
_ _ _Product Monograph - ACH-SITAGLIPTIN _ _Page 1 of 57_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ACH-SITAGLIPTIN sitagliptin tablets Tablets, 25, 50 and 100 mg sitagliptin (as sitagliptin phosphate anhydrous), Oral House Standard ATC Code: A10BH01 Dipeptidyl peptidase 4 (DPP-4) inhibitors Accord Healthcare Inc. 3535 boul. St. Charles, Suite 704 Kirkland, QC, H9H 5B9 Canada Date of Initial Authorization: February 15, 2021 Date of Revision: September 22, 2022 Submission Control Number: 263618 _Product Monograph - ACH-SITAGLIPTIN Page _2_ of _57 RECENT MAJOR LABEL CHANGES 1 Indications 09/2022 4 Dosage and Administration 09/2022 7 Warnings and Precautions 09/2022 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 CONTRAINDICA TIONS ...................................................................................................4 4 DOSAGE AND ADMINISTRATION ..................................................................................4 4.1 Dosing Considerations ........................................................................................ 4 4.2 Recommended Dose and Dosage Adjustment...................................................... 5 4.4 Administration................................ Прочетете целия документ