NRA-CANDESARTAN TABLET
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
03-05-2022
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Aktiv ingrediens:
CANDESARTAN CILEXETIL
Tilgjengelig fra:
NORA PHARMA INC
ATC-kode:
C09CA06
INN (International Name):
CANDESARTAN
Dosering :
32MG
Legemiddelform:
TABLET
Sammensetning:
CANDESARTAN CILEXETIL 32MG
Administreringsrute:
ORAL
Enheter i pakken:
15G/50G
Resept typen:
Prescription
Produkt oppsummering:
Active ingredient group (AIG) number: 0135220004; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2022-05-03
Preparatomtale
______________________________________________________________________________
_NRA-Candesartan Product Monograph_
_ Page 1 of 39_
PRODUCT MONOGRAPH
PR
NRA-CANDESARTAN
Candesartan Cilexetil Tablets
4 mg, 8 mg, 16 mg and 32 mg
Angiotensin II AT
1
Receptor Blocker
Nora Pharma Inc.
1565 Lionel-Boulet Blvd.
Varennes, Quebec
J3X 1P7
Submission Control Numbers: 256986
DATE OF PREPARATION:
May 3, 2022
______________________________________________________________________________
_NRA-Candesartan Product Monograph_
_ Page 2 of 39_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION...............................................................3
SUMMARY PRODUCT
INFORMATION...........................................................................3
INDICATIONS AND CLINICAL
USE.................................................................................3
CONTRAINDICATIONS......................................................................................................4
WARNINGS AND PRECAUTIONS
....................................................................................5
ADVERSE
REACTIONS.......................................................................................................9
DRUG
INTERACTIONS.....................................................................................................15
DOSAGE AND ADMINISTRATION
................................................................................19
OVERDOSAGE...................................................................................................................22
ACTION AND CLINICAL
PHARMACOLOGY...............................................................22
STORAGE AND
STABILITY.............................................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................25
PART II: SCIENTIFIC
INFORMATION.....................................................................................26
PHARMACEUTICAL
INFORMATION....................
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