RIVA-CANDESARTAN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

CANDESARTAN CILEXETIL

Boleh didapati daripada:

LABORATOIRE RIVA INC.

Kod ATC:

C09CA06

INN (Nama Antarabangsa):

CANDESARTAN

Dos:

4MG

Borang farmaseutikal:

TABLET

Komposisi:

CANDESARTAN CILEXETIL 4MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0135220001; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2019-04-01

Ciri 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
............................................................................................