Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE); DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE)
ASTRAZENECA CANADA INC
A10BD21
SAXAGLIPTIN AND DAPAGLIFLOZIN
5MG; 5MG
TABLET
SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE) 5MG; DAPAGLIFLOZIN (DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE) 5MG
ORAL
30
Prescription
DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITORS
Active ingredient group (AIG) number: 0258571001; AHFS:
CANCELLED PRE MARKET
2022-09-26
COPYRIGHT 2021 ASTRAZENECA CANADA INC. Page 1 of 57 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION QTERN ® saxagliptin and dapagliflozin tablets (as saxagliptin hydrochloride and dapagliflozin propanediol monohydrate) 5 mg/5 mg and 5 mg/10 mg ATC Code: A10BD21 Combinations of oral blood glucose lowering drugs AstraZeneca Canada Inc. 1004 Middlegate Road Mississauga, Ontario L4Y 1M4 www.astrazeneca.ca Date of Revision: June 29, 2021 Submission Control No: 249090 QTERN ® is a registered trademark of AstraZeneca AB, used under license by AstraZeneca Canada Inc. COPYRIGHT 2021 ASTRAZENECA CANADA INC. Page 2 of 57 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION..................................................... 3 SUMMARY PRODUCT INFORMATION ................................................................. 3 INDICATIONS AND CLINICAL USE....................................................................... 3 CONTRAINDICATIONS ........................................................................................... 4 WARNINGS AND PRECAUTIONS .......................................................................... 4 ADVERSE REACTIONS ......................................................................................... 11 DRUG INTERACTIONS.......................................................................................... 21 DOSAGE AND ADMINISTRATION....................................................................... 29 OVERDOSAGE ....................................................................................................... 31 ACTION AND CLINICAL PHARMACOLOGY ...................................................... 31 STORAGE AND STABILITY.................................................................................. 39 SPECIAL HANDLING INSTRUCTIONS ................................................................ 39 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................ 40 PART II: SCIENTIFIC INFORMATION ........................................ Baca dokumen lengkap