Riik: Kanada
keel: inglise
Allikas: Health Canada
SITAGLIPTIN (SITAGLIPTIN PHOSPHATE)
DR REDDY'S LABORATORIES LTD
A10BH01
SITAGLIPTIN
100MG
TABLET
SITAGLIPTIN (SITAGLIPTIN PHOSPHATE) 100MG
ORAL
100
Prescription
Active ingredient group (AIG) number: 0152414001; AHFS:
APPROVED
2023-03-31
Page 1 of 58 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR REDDY-SITAGLIPTIN Sitagliptin Tablets, USP 25, 50 and 100 mg (as sitagliptin phosphate), Oral Dipeptidyl peptidase 4 (DPP-4) inhibitors MANUFACTURED BY: DR. REDDY’S LABORATORIES LTD., Bachupally – 500 090 India IMPORTED AND DISTRIBUTED BY: DR. REDDY’S LABORATORIES CANADA INC. Mississauga, ON L4W 4Y1 Canada Submission Control No: 241543 Date of Preparation: March 30, 2023 Page 2 of 58 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...........................................................................................5 4.1 Dosing Considerations........................................................................................................ 5 4.2 Recommended Dose and Dosage Adjustment...................................................................5 4.4 Administration.....................................................................................................................6 4.5 Missed Dose.......................................................................................................................6 5 OVERDOSAGE.........................................................................................................................6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND Lugege kogu dokumenti