NRA-CANDESARTAN TABLET
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
03-05-2022
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Aktivní složka:
CANDESARTAN CILEXETIL
Dostupné s:
NORA PHARMA INC
ATC kód:
C09CA06
INN (Mezinárodní Name):
CANDESARTAN
Dávkování:
16MG
Léková forma:
TABLET
Složení:
CANDESARTAN CILEXETIL 16MG
Podání:
ORAL
Jednotky v balení:
15G/50G
Druh předpisu:
Prescription
Přehled produktů:
Active ingredient group (AIG) number: 0135220003; AHFS:
Stav Autorizace:
APPROVED
Datum autorizace:
2022-05-03
Charakteristika produktu
______________________________________________________________________________
_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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