Pays: Canada
Langue: anglais
Source: Health Canada
CANDESARTAN CILEXETIL
AURO PHARMA INC
C09CA06
CANDESARTAN
32MG
TABLET
CANDESARTAN CILEXETIL 32MG
ORAL
30/90/500
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0135220004; AHFS:
APPROVED
2015-09-18
Page 1 of 36 PRODUCT MONOGRAPH PR AURO-CANDESARTAN candesartan cilexetil tablets 4 mg, 8 mg, 16 mg and 32 mg House standard Angiotensin II AT 1 Receptor Blocker AURO PHARMA INC. Date of Revision: 3700 Steeles Avenue West, Suite # 402 September 27, 2018 Woodbridge, Ontario, L4L 8K8 CANADA Submission Control No: 211944 Page 2 of 36 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 ................................................................................................. 14 DOSAGE AND ADMINISTRATION ............................................................................. 16 OVERDOSAGE ............................................................................................................... 19 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 19 STORAGE AND STABILITY ......................................................................................... 22 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 22 PART II: SCIENTIFIC INFORMATION ............................................................................... 23 PHARMACEUTICAL INFORMATION ......................................................................... 23 CLINICAL TRIALS ......................................................................................................... 24 DETAILED PHARMACOLOGY ...................... Lire le document complet