RIVA-CANDESARTAN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CANDESARTAN CILEXETIL

Tersedia dari:

LABORATOIRE RIVA INC.

Kode ATC:

C09CA06

INN (Nama Internasional):

CANDESARTAN

Dosis:

32MG

Bentuk farmasi:

TABLET

Komposisi:

CANDESARTAN CILEXETIL 32MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100

Jenis Resep:

Prescription

Area terapi:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0135220004; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2019-04-01

Karakteristik produk

_RIVA-CANDESARTAN Product Monograph_
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
RIVA-CANDESARTAN
Candesartan cilexetil tablets
4 mg, 8 mg, 16 mg and 32 mg
ANGIOTENSIN II AT
1 RECEPTOR BLOCKER
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Québec
J7C 3V4
www.labriva.com
DATE OF REVISION
:
October 17, 2016
Submission Control No: 198061
_RIVA-CANDESARTAN Product Monograph_
_Page 2 of 38_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
....................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
8
DRUG INTERACTIONS
..................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
16
OVERDOSAGE
................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 19
STORAGE AND STABILITY
.........................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 22
PART II: SCIENTIFIC INFORMATION
.............................................................................
23
PHARMACEUTICAL INFORMATION
.........................................................................
23
CLINICAL TRIALS
............................................................................................