Land: Kanada
Språk: engelska
Källa: Health Canada
SITAGLIPTIN (SITAGLIPTIN PHOSPHATE)
MANTRA PHARMA INC
A10BH01
SITAGLIPTIN
50MG
TABLET
SITAGLIPTIN (SITAGLIPTIN PHOSPHATE) 50MG
ORAL
100
Prescription
Active ingredient group (AIG) number: 0152414003; AHFS:
APPROVED
2023-02-06
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR M-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 Mantra Pharma Inc. 9150 Leduc Blvd., Suite 201 Brossard, Quebec J4Y 0E3 Submission Control Number: 270679 Date of Initial Authorization: FEB 02, 2023 _Product Monograph – M-SITAGLIPTIN_ _Page 2 of 54_ RECENT MAJOR LABEL CHANGES N/A _ _ _ _ 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 ................................................................................................ 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 ...................................................................................... Läs hela dokumentet