Држава: Канада
Језик: Енглески
Извор: Health Canada
SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE)
ASTRAZENECA CANADA INC
A10BH03
SAXAGLIPTIN
2.5MG
TABLET
SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE) 2.5MG
ORAL
30
Prescription
DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITORS
Active ingredient group (AIG) number: 0152653002; AHFS:
APPROVED
2014-06-30
COPYRIGHT 2009-2021 ASTRAZENECA CANADA INC. Page 1 of 44 PRODUCT MONOGRAPH ONGLYZA ® saxagliptin tablets (as saxagliptin hydrochloride) 2.5 and 5 mg Oral Antihyperglycemic Agent DPP-4 inhibitor Incretin Enhancer AstraZeneca Canada Inc. 1004 Middlegate Road Mississauga, Ontario L4Y 1M4 www.astrazeneca.ca Date of Revision: June 29, 2021 Submission Control No: 249068 ONGLYZA ® is a registered trademark of AstraZeneca AB, used under license by AstraZeneca Canada Inc. COPYRIGHT 2009-2021 ASTRAZENECA CANADA INC. Page 2 of 44 TABLE OF CONTENTS TABLE OF CONTENTS ................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION..................................................... 3 SUMMARY PRODUCT INFORMATION ................................................................. 3 INDICATIONS AND CLINICAL USE....................................................................... 3 CONTRAINDICATIONS ........................................................................................... 4 WARNINGS AND PRECAUTIONS .......................................................................... 4 ADVERSE REACTIONS ........................................................................................... 7 DRUG INTERACTIONS.......................................................................................... 17 DOSAGE AND ADMINISTRATION....................................................................... 21 OVERDOSAGE ....................................................................................................... 22 ACTION AND CLINICAL PHARMACOLOGY ...................................................... 22 STORAGE AND STABILITY.................................................................................. 26 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................ 26 PART II: SCIENTIFIC INFORMATION......................................................................... 27 PHARMACEUTICAL INFORMATION................... Прочитајте комплетан документ