RIVA-CANDESARTAN TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
20-10-2016
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Werkstoffen:
CANDESARTAN CILEXETIL
Beschikbaar vanaf:
LABORATOIRE RIVA INC.
ATC-code:
C09CA06
INN (Algemene Internationale Benaming):
CANDESARTAN
Dosering:
4MG
farmaceutische vorm:
TABLET
Samenstelling:
CANDESARTAN CILEXETIL 4MG
Toedieningsweg:
ORAL
Eenheden in pakket:
30/100
Prescription-type:
Prescription
Therapeutisch gebied:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product samenvatting:
Active ingredient group (AIG) number: 0135220001; AHFS:
Autorisatie-status:
CANCELLED POST MARKET
Autorisatie datum:
2019-04-01
Productkenmerken
_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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