Land: Canada
Sprog: engelsk
Kilde: Health Canada
GLIMEPIRIDE
APOTEX INC
A10BB12
GLIMEPIRIDE
4MG
TABLET
GLIMEPIRIDE 4MG
ORAL
100
Prescription
SULFONYLUREAS
Active ingredient group (AIG) number: 0146247003; AHFS:
APPROVED
2007-05-16
Page 1 of 51 PRODUCT MONOGRAPH PR APO-GLIMEPIRIDE GLIMEPIRIDE TABLETS USP 1 MG, 2 MG AND 4 MG ORAL HYPOGLYCEMIC (SULFONYLUREA) APOTEX INC. DATE OF REVISION: 150 SIGNET DRIVE OCTOBER 17, 2018 TORONTO, ONTARIO CANADA M9L 1T9 _ _ _ _ SUBMISSION CONTROL NO.: 219952 Page 2 of 51 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 ....................................................................................................... 11 DOSAGE AND ADMINISTRATION ................................................................................... 15 OVERDOSAGE ...................................................................................................................... 17 ACTION AND CLINICAL PHARMACOLOGY ................................................................. 17 STORAGE AND STABILITY ............................................................................................... 21 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................. 21 PART II: SCIENTIFIC INFORMATION .............................................................................. 23 PHARMACEUTICAL INFORMATION ............................................................................... 23 CLINICAL TRIALS ............................................................................................................... 25 DETAILED PHARMACOLOGY .. Læs hele dokumentet