ARCOSYL PLUS LD TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

PERINDOPRIL ARGININE; INDAPAMIDE

Доступно од:

SERVIER CANADA INC

АТЦ код:

C09BA04

INN (Међународно име):

PERINDOPRIL AND DIURETICS

Дозирање:

2.5MG; 0.625MG

Фармацеутски облик:

TABLET

Састав:

PERINDOPRIL ARGININE 2.5MG; INDAPAMIDE 0.625MG

Пут администрације:

ORAL

Јединице у пакету:

14/20/28/30/50

Тип рецептора:

Prescription

Терапеутска област:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Резиме производа:

Active ingredient group (AIG) number: 0252492002; AHFS:

Статус ауторизације:

CANCELLED PRE MARKET

Датум одобрења:

2019-06-26

Карактеристике производа

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
...........................................................................................