国: カナダ
言語: 英語
ソース: Health Canada
VALSARTAN
APOTEX INC
C09CA03
VALSARTAN
80MG
TABLET
VALSARTAN 80MG
ORAL
30
Prescription
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Active ingredient group (AIG) number: 0131885001; AHFS:
MARKETED
2012-07-12
_APO-VALSARTAN Tablets Product Monograph_ _ _Page 1 of 41 PRODUCT MONOGRAPH PR APO-VALSARTAN (VALSARTAN) 40 MG, 80 MG, 160 MG AND 320 MG TABLETS Angiotensin II AT 1 Receptor Blocker APOTEX INC. DATE OF REVISION: 150 SIGNET DRIVE SEPTEMBER 16, 2015 TORONTO, ONTARIO M9L 1T9 CONTROL NUMBER: 187072 _APO-VALSARTAN Tablets Product Monograph_ _ _Page 2 of 41 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .............................................................. 3 SUMMARY PRODUCT INFORMATION ............................................................................... 3 INDICATIONS AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS ....................................................................................................... 4 WARNINGS AND PRECAUTION ......................................................................................... 4 ADVERSE REACTIONS ...................................................................................................... 8 DRUG INTERACTIONS ......................................................................................................12 DOSAGE AND ADMINISTRATION .....................................................................................14 OVERDOSAGE ...................................................................................................................16 ACTION AND CLINICAL PHARMACOLOGY ......................................................................16 STORAGE AND STABILITY................................................................................................19 SPECIAL HANDLING INSTRUCTIONS ..............................................................................19 DOSAGE FORMS, COMPOSITION AND PACKAGING ......................................................19 PART II: SCIENTIFIC INFORMATION ....................................................................................21 PHARMACEUTICAL INFORMATION ................................... 完全なドキュメントを読む