RIVA-CANDESARTAN TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

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Last ned Preparatomtale (SPC)
20-10-2016

Aktiv ingrediens:

CANDESARTAN CILEXETIL

Tilgjengelig fra:

LABORATOIRE RIVA INC.

ATC-kode:

C09CA06

INN (International Name):

CANDESARTAN

Dosering :

4MG

Legemiddelform:

TABLET

Sammensetning:

CANDESARTAN CILEXETIL 4MG

Administreringsrute:

ORAL

Enheter i pakken:

30/100

Resept typen:

Prescription

Terapeutisk område:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Produkt oppsummering:

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

Autorisasjon status:

CANCELLED POST MARKET

Autorisasjon dato:

2019-04-01

Preparatomtale

                                _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
............................................................................................
                                
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