国: カナダ
言語: 英語
ソース: Health Canada
CANDESARTAN CILEXETIL
NORA PHARMA INC
C09CA06
CANDESARTAN
4MG
TABLET
CANDESARTAN CILEXETIL 4MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0135220001; AHFS:
APPROVED
2022-05-03
______________________________________________________________________________ _NRA-Candesartan Product Monograph_ _ Page 1 of 39_ PRODUCT MONOGRAPH PR NRA-CANDESARTAN Candesartan Cilexetil Tablets 4 mg, 8 mg, 16 mg and 32 mg Angiotensin II AT 1 Receptor Blocker Nora Pharma Inc. 1565 Lionel-Boulet Blvd. Varennes, Quebec J3X 1P7 Submission Control Numbers: 256986 DATE OF PREPARATION: May 3, 2022 ______________________________________________________________________________ _NRA-Candesartan Product Monograph_ _ Page 2 of 39_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION...............................................................3 SUMMARY PRODUCT INFORMATION...........................................................................3 INDICATIONS AND CLINICAL USE.................................................................................3 CONTRAINDICATIONS......................................................................................................4 WARNINGS AND PRECAUTIONS ....................................................................................5 ADVERSE REACTIONS.......................................................................................................9 DRUG INTERACTIONS.....................................................................................................15 DOSAGE AND ADMINISTRATION ................................................................................19 OVERDOSAGE...................................................................................................................22 ACTION AND CLINICAL PHARMACOLOGY...............................................................22 STORAGE AND STABILITY.............................................................................................24 DOSAGE FORMS, COMPOSITION AND PACKAGING ...............................................25 PART II: SCIENTIFIC INFORMATION.....................................................................................26 PHARMACEUTICAL INFORMATION.................... 完全なドキュメントを読む