AURO-CANDESARTAN HCT Comprimé

Land: Canada

Sprog: fransk

Kilde: Health Canada

Aktiv bestanddel:

Candésartan cilexétil; Hydrochlorothiazide

Tilgængelig fra:

AURO PHARMA INC

ATC-kode:

C09DA06

INN (International Name):

CANDERSARTAN AND DIURETICS

Dosering:

32MG; 25MG

Lægemiddelform:

Comprimé

Sammensætning:

Candésartan cilexétil 32MG; Hydrochlorothiazide 25MG

Indgivelsesvej:

Orale

Enheder i pakken:

30/100/500

Recept type:

Prescription

Terapeutisk område:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Produkt oversigt:

Numéro de groupe d'ingrédients actifs (GIA) :0244181003; AHFS:

Autorisation status:

APPROUVÉ

Autorisation dato:

2014-06-09

Produktets egenskaber

Page 1 of 46
PRODUCT MONOGRAPH
PR
AURO-CANDESARTAN HCT
candesartan cilexetil/hydrochlorothiazide tablets
16 mg / 12.5 mg, 32 mg / 12.5 mg and 32 mg / 25 mg
Professed Standard
Angiotensin II AT
1
Receptor Blocker + Diuretic
AURO PHARMA INC.
Date of Revision:
3700 Steeles Avenue West, Suite # 402
August 26, 2019.
Woodbridge, Ontario, L4L 8K8
CANADA
Submission Control No: 230895
Page 2 of 46
TABLE OF CONTENTS
_ _
PART I:
HEALTH PROFESSIONAL INFORMATION.......………..............
3
SUMMARY PRODUCT INFORMATION…....................….............
3
INDICATIONS AND CLINICAL
USE…....................……..............
3
CONTRAINDICATIONS…........................................………...........
3
WARNINGS AND
PRECAUTIONS............................……..............
4
ADVERSE
REACTIONS.......................................………….............
9
DRUG
INTERACTIONS…............................……………................
14
DOSAGE AND
ADMINISTRATION…............…............................
20
OVERDOSAGE.........................................………….........................
22
ACTION AND CLINICAL PHARMACOLOGY…..........................
22
STORAGE AND
STABILITY…......................................……..........
26
DOSAGE FORMS, COMPOSITION AND PACKAGING……….....
26
PART II:
SCIENTIFIC
INFORMATION............................…………….….......
27
PHARMACEUTICAL INFORMATION...........................….............
27
CLINICAL
TRIALS.................................................…………….......
28
DETAILED
PHARMACOLOGY.................................………….…..
32
TOXICOLOGY………………………………………………………..
33
REFERENCES…....................................…………………………......
37
PART III:
CONSUMER
INFORMATION.....................…………………….......
38
Page 3 of 46
PR
AURO-CANDESARTAN HCT
candesartan cilexetil/hydrochlorothiazide tablets
16 mg / 12.5 mg, 32 mg / 12.5 mg and 32 mg / 25 mg
Pro