AURO-CANDESARTAN HCT Comprimé

Land: Kanada

Sprache: Französisch

Quelle: Health Canada

Wirkstoff:

Candésartan cilexétil; Hydrochlorothiazide

Verfügbar ab:

AURO PHARMA INC

ATC-Code:

C09DA06

INN (Internationale Bezeichnung):

CANDERSARTAN AND DIURETICS

Dosierung:

32MG; 12.5MG

Darreichungsform:

Comprimé

Zusammensetzung:

Candésartan cilexétil 32MG; Hydrochlorothiazide 12.5MG

Verabreichungsweg:

Orale

Einheiten im Paket:

30/100/500

Verschreibungstyp:

Prescription

Therapiebereich:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Produktbesonderheiten:

Numéro de groupe d'ingrédients actifs (GIA) :0244181002; AHFS:

Berechtigungsstatus:

APPROUVÉ

Berechtigungsdatum:

2014-06-09

Fachinformation

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