ARCOSYL PLUS LD TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

PERINDOPRIL ARGININE; INDAPAMIDE

Tersedia dari:

SERVIER CANADA INC

Kode ATC:

C09BA04

INN (Nama Internasional):

PERINDOPRIL AND DIURETICS

Dosis:

2.5MG; 0.625MG

Bentuk farmasi:

TABLET

Komposisi:

PERINDOPRIL ARGININE 2.5MG; INDAPAMIDE 0.625MG

Rute administrasi :

ORAL

Unit dalam paket:

14/20/28/30/50

Jenis Resep:

Prescription

Area terapi:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Ringkasan produk:

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

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2019-06-26

Karakteristik produk

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