국가: 캐나다
언어: 영어
출처: Health Canada
PERINDOPRIL ARGININE; INDAPAMIDE
SERVIER CANADA INC
C09BA04
PERINDOPRIL AND DIURETICS
2.5MG; 0.625MG
TABLET
PERINDOPRIL ARGININE 2.5MG; INDAPAMIDE 0.625MG
ORAL
14/20/28/30/50
Prescription
ANGIOTENSIN-CONVERTING ENZYME INHIBITORS
Active ingredient group (AIG) number: 0252492002; AHFS:
CANCELLED PRE MARKET
2019-06-26
PRODUCT MONOGRAPH PR ARCOSYL ® PLUS LD 2.5 MG / 0.625 MG film-coated tablets PR ARCOSYL ® PLUS 5 MG / 1.25 MG film-coated tablets 10 MG / 2.5 MG film-coated tablets (perindopril arginine / indapamide) Angiotensin converting enzyme inhibitor / Diuretic SERVIER CANADA INC. 235, Boulevard Armand Frappier Laval, Québec H7V 4A7 Submission Control No.: 213434 Date of Revision: June 5, 2018 _Product Monograph - ARCOSYL_ _®_ _ PLUS LD / ARCOSYL_ _® _ _PLUS _ _Page 2 of 65_ 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 ..................................................................................... 16 DRUG INTERACTIONS ...................................................................................... 23 DOSAGE AND ADMINISTRATION .................................................................. 28 OVERDOSAGE .................................................................................................... 29 ACTION AND CLINICAL PHARMACOLOGY ................................................ 30 STORAGE AND STABILITY ............................................................................. 35 SPECIAL HANDLING INSTRUCTIONS ........................................................... 35 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................. 35 PART II: SCIENTIFIC INFORMATION ............................................................... 37 PHARMACEUTICAL INFORMATION ............................................................. 37 CLINICAL TRIALS ........................................................................................... 전체 문서 읽기