PMS-CANDESARTAN TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
12-10-2016
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Werkstoffen:
CANDESARTAN CILEXETIL
Beschikbaar vanaf:
PHARMASCIENCE INC
ATC-code:
C09CA06
INN (Algemene Internationale Benaming):
CANDESARTAN
Dosering:
16MG
farmaceutische vorm:
TABLET
Samenstelling:
CANDESARTAN CILEXETIL 16MG
Toedieningsweg:
ORAL
Eenheden in pakket:
30/100
Prescription-type:
Prescription
Therapeutisch gebied:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product samenvatting:
Active ingredient group (AIG) number: 0135220003; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2012-08-03
Productkenmerken
_pms-CANDESARTAN Product Monograph_
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
PMS-CANDESARTAN
Candesartan cilexetil tablets
4 mg, 8 mg, 16 mg and 32 mg
ANGIOTENSIN II AT
1 RECEPTOR BLOCKER
PHARMASCIENCE INC.
6111 Av. Royalmount, Suite 100
Montréal, Québec
H4P 2T4
Date of Revision:
JULY 19, 2016
Submission Control No: 195306
_pms-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
.........................................................................................................
24
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