NRA-CANDESARTAN TABLET
Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
Produkta apraksts
(SPC)
03-05-2022
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Aktīvā sastāvdaļa:
CANDESARTAN CILEXETIL
Pieejams no:
NORA PHARMA INC
ATĶ kods:
C09CA06
SNN (starptautisko nepatentēto nosaukumu):
CANDESARTAN
Deva:
4MG
Zāļu forma:
TABLET
Kompozīcija:
CANDESARTAN CILEXETIL 4MG
Ievadīšanas:
ORAL
Vienības iepakojumā:
15G/50G
Receptes veids:
Prescription
Produktu pārskats:
Active ingredient group (AIG) number: 0135220001; AHFS:
Autorizācija statuss:
APPROVED
Autorizācija datums:
2022-05-03
Produkta apraksts
______________________________________________________________________________
_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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