DOM-CANDESARTAN TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
28-10-2016
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Aktiv ingrediens:
CANDESARTAN CILEXETIL
Tilgjengelig fra:
DOMINION PHARMACAL
ATC-kode:
C09CA06
INN (International Name):
CANDESARTAN
Dosering :
16MG
Legemiddelform:
TABLET
Sammensetning:
CANDESARTAN CILEXETIL 16MG
Administreringsrute:
ORAL
Enheter i pakken:
30/100
Resept typen:
Prescription
Terapeutisk område:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0135220003; AHFS:
Autorisasjon status:
CANCELLED PRE MARKET
Autorisasjon dato:
2019-02-07
Preparatomtale
_Dom-CANDESARTAN Product Monograph_
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
DOM-CANDESARTAN
Candesartan cilexetil tablets
4 mg, 8 mg, 16 mg and 32 mg
ANGIOTENSIN II AT
1 RECEPTOR BLOCKER
DOMINION PHARMACAL
6111 Av. Royalmount, Suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION
:
October 19, 2016
Submission Control No: 198053
_Dom-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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