AURO-CANDESARTAN HCT TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE

Доступно од:

AURO PHARMA INC

АТЦ код:

C09DA06

INN (Међународно име):

CANDERSARTAN AND DIURETICS

Дозирање:

32MG; 25MG

Фармацеутски облик:

TABLET

Састав:

CANDESARTAN CILEXETIL 32MG; HYDROCHLOROTHIAZIDE 25MG

Пут администрације:

ORAL

Јединице у пакету:

30/100/500

Тип рецептора:

Prescription

Терапеутска област:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Резиме производа:

Active ingredient group (AIG) number: 0244181003; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2014-06-09

Карактеристике производа

Auro-Candesartan HCT Product Monograph
Page 1 of 50
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-CANDESARTAN HCT
Candesartan cilexetil/hydrochlorothiazide tablets
Tablets, 16 mg / 12.5 mg, 32 mg / 12.5 mg and 32 mg / 25 mg, Oral use
Angiotensin II AT
1
Receptor Blocker + Diuretic (C09DA06)
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
CANADA
Date of Initial Authorization:
February 12, 2014
Date of Revision:
October 18, 2023
Submission Control Number: 275538
Auro-Candesartan HCT Product Monograph
Page 2 of 50
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions – Carcinogenesis and Mutagenesis,
Ophthalmologic, Skin
05/2022
7 Warnings and Precautions – Respiratory
10/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1 INDICATIONS
........................................................................................................................
4
1.1 Pediatrics
.........................................................................................................................
4
1.2 Geriatrics
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4
2 CONTRAINDICATIONS
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4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
......................................................................
5
4 DOSAGE AND ADMINISTRATION
...........................................................................................
5
4.1 Dosing Considerations
..................