APO-CANDESARTAN TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
29-01-2019
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Werkstoffen:
CANDESARTAN CILEXETIL
Beschikbaar vanaf:
APOTEX INC
ATC-code:
C09CA06
INN (Algemene Internationale Benaming):
CANDESARTAN
Dosering:
8MG
farmaceutische vorm:
TABLET
Samenstelling:
CANDESARTAN CILEXETIL 8MG
Toedieningsweg:
ORAL
Eenheden in pakket:
100/500
Prescription-type:
Prescription
Therapeutisch gebied:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Product samenvatting:
Active ingredient group (AIG) number: 0135220002; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2011-04-26
Productkenmerken
_APO-CANDESARTAN Tablets Product Monograph_
Page 1 of 34
PRODUCT MONOGRAPH
PR
APO-CANDESARTAN
CANDESARTAN CILEXETIL TABLETS USP
4 MG, 8 MG, 16 MG AND 32 MG
ANGIOTENSIN II AT
1 RECEPTOR BLOCKER
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
JANUARY 29, 2019
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 222632
_APO-CANDESARTAN Tablets Product Monograph_
Page 2 of 34
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 3
_SUMMARY PRODUCT INFORMATION
.................................................................................................
3_
_INDICATIONS AND CLINICAL USE
.......................................................................................................
3_
_CONTRAINDICATIONS
...........................................................................................................................
3_
_WARNINGS AND
PRECAUTIONS..........................................................................................................
4_
_ADVERSE REACTIONS
..........................................................................................................................
7_
_DRUG INTERACTIONS
.........................................................................................................................
13_
_DOSAGE AND ADMINISTRATION
.......................................................................................................
16_
_OVERDOSAGE
.....................................................................................................................................
18_
_ACTION AND CLINICAL PHARMACOLOGY
........................................................................................
18_
_STORAGE AND STABILITY
..................................................................................................................
21_
_DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................................
21_
PART II: SCIENTIFIC INFORMATION
..................
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