Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE)
PHARMASCIENCE INC
A10BH01
SITAGLIPTIN
50MG
TABLET
SITAGLIPTIN (SITAGLIPTIN PHOSPHATE MONOHYDRATE) 50MG
ORAL
100
Prescription
Active ingredient group (AIG) number: 0152414003; AHFS:
APPROVED
2023-01-05
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PMS-SITAGLIPTIN Sitagliptin Tablets Tablets, 25, 50 and 100 mg sitagliptin (as sitagliptin phosphate monohydrate) Oral House Standard Dipeptidyl peptidase 4 (DPP-4) inhibitors PHARMASCIENCE INC 6111 Royalmount Ave., Suite 100 Montréal, Canada H4P 2T4 Date of Initial Authorization: August 18, 2020 Date of Revision: December 14, 2021 www.pharmascience.com Submission Control Number: 254974 _pms-SITAGLIPTIN (sitagliptin) Page 2 of 56 _ RECENT MAJOR LABEL CHANGES 1 Indications 12/2021 4 Dosage and Administration 12/2021 7 Warnings and Precautions 12/2021 TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED . PART I: HEALTH PROFESSIONAL INFORMATION...............................................................................4 1 INDICATIONS ....................................................................................................................4 1.1 Pediatrics ....................................................................................................................4 1.2 Geriatrics ....................................................................................................................4 2 CONTRAINDICATIONS ........................................................................................................4 4 DOSAGE AND ADMINISTRATION .........................................................................................4 4.1 Dosing Considerations...................................................................................................4 4.2 Recommended Dose and Dosage Adjustment...................................................................5 4.4 Administration .............................................................................................................5 4.5 Missed Dose ................................................................................................................6 5 OVERDOSAGE ............................................ Izlasiet visu dokumentu