Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE)
TEVA CANADA LIMITED
A10BH03
SAXAGLIPTIN
2.5MG
TABLET
SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE) 2.5MG
ORAL
30/100
Prescription
DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITORS
Active ingredient group (AIG) number: 0152653002; AHFS:
CANCELLED PRE MARKET
2021-05-04
PRODUCT MONOGRAPH PR TEVA-SAXAGLIPTIN saxagliptin (as saxagliptin hydrochloride) 2.5 mg and 5 mg Tablets Oral Antihyperglycemic Agent DPP-4 inhibitor Incretin Enhancer Teva Canada Limited Date of Revision; 30 Novopharm Court January 25, 2021 Toronto, Ontario M1B 2K9 Control No.: 247036 2 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 .................................................................................................... 8 DRUG INTERACTIONS ................................................................................................... 16 DOSAGE AND ADMINISTRATION ................................................................................ 20 OVERDOSAGE ................................................................................................................. 21 ACTION AND CLINICAL PHARMACOLOGY .............................................................. 21 STORAGE AND STABILITY ........................................................................................... 24 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................ 25 PART II: SCIENTIFIC INFORMATION PHARMACEUTICAL INFORMATION............................................................................ 26 CLINICAL TRIALS .......................................................................................................... 26 DETAILED PHARMACOLOGY ...................................................................................... 37 TOXICOLOGY ...................... Perskaitykite visą dokumentą