Land: Canada
Språk: engelsk
Kilde: Health Canada
CANDESARTAN CILEXETIL
SANIS HEALTH INC
C09CA06
CANDESARTAN
8MG
TABLET
CANDESARTAN CILEXETIL 8MG
ORAL
30/100/500
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0135220002; AHFS:
APPROVED
2012-07-18
_ _ _Page 1 of 35_ _CANDESARTAN_ PRODUCT MONOGRAPH PR CANDESARTAN Candesartan Cilexetil Tablets 4 mg, 8 mg, 16 mg and 32 mg Manufacturer's Standard Angiotensin II AT 1 Receptor Blocker Sanis Health Inc. 1 President's Choice Circle Brampton, Ontario L6Y 5S5 Submission Control No.: 263148 Date of Revision: May 13, 2022 _ _ _CANDESARTAN _ _Page 2 of 35_ 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 ........................................................................................................... 12 DOSAGE AND ADMINISTRATION ....................................................................................... 14 OVERDOSAGE ......................................................................................................................... 17 ACTION AND CLINICAL PHARMACOLOGY ..................................................................... 17 STORAGE AND STABILITY................................................................................................... 19 DOSAGE FORMS, COMPOSITION AND PACKAGING ...................................................... 19 PART II: SCIENTIFIC INFORMATION ................................................................................ 21 PHARMACEUTICAL INFORMATION .................................................................................. 21 CLINICAL TRIALS .............. Les hele dokumentet