TEVA-CANDESARTAN TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
09-05-2016
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Aktiv ingrediens:
CANDESARTAN CILEXETIL
Tilgjengelig fra:
TEVA CANADA LIMITED
ATC-kode:
C09CA06
INN (International Name):
CANDESARTAN
Dosering :
8MG
Legemiddelform:
TABLET
Sammensetning:
CANDESARTAN CILEXETIL 8MG
Administreringsrute:
ORAL
Enheter i pakken:
30/100
Resept typen:
Prescription
Terapeutisk område:
ANGIOTENSIN II RECEPTOR ANTAGONISTS
Produkt oppsummering:
Active ingredient group (AIG) number: 0135220002; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2012-02-10
Preparatomtale
PRODUCT MONOGRAPH
PR
TEVA-CANDESARTAN
Candesartan cilexetil Tablets
8 mg, 16 mg, and 32 mg
Angiotensin II AT
1
Receptor Blocker
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Control No. 194121
Date of Revision:
May 2, 2016
2
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
.....................................................................................
13
DOSAGE AND ADMINISTRATION
................................................................. 15
OVERDOSAGE
...................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
............................................... 18
STORAGE AND STABILITY
.............................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................ 20
PART II: SCIENTIFIC INFORMATION
....................................................................................
22
PHARMACEUTICAL INFORMATION
............................................................. 22
CLINICAL TRIALS
.............................................................................................
23
DETAILED PHARMACOLOGY
........................................................................
26
TOXICOLOGY
....................................................................................................
26
REFERENCES
.......................................................
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