PMS-CANDESARTAN TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
12-10-2016
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Aktiv bestanddel:
CANDESARTAN CILEXETIL
Tilgængelig fra:
PHARMASCIENCE INC
ATC-kode:
C09CA06
INN (International Name):
CANDESARTAN
Dosering:
4MG
Lægemiddelform:
TABLET
Sammensætning:
CANDESARTAN CILEXETIL 4MG
Indgivelsesvej:
ORAL
Enheder i pakken:
30/100
Recept type:
Prescription
Terapeutisk område:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Produkt oversigt:
Active ingredient group (AIG) number: 0135220001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2012-08-03
Produktets egenskaber
_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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