AURO-IRBESARTAN HCT TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

IRBESARTAN; HYDROCHLOROTHIAZIDE

Доступно од:

AURO PHARMA INC

АТЦ код:

C09DA04

INN (Међународно име):

IRBESARTAN AND DIURETICS

Дозирање:

300MG; 25MG

Фармацеутски облик:

TABLET

Састав:

IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 25MG

Пут администрације:

ORAL

Јединице у пакету:

30/90

Тип рецептора:

Prescription

Терапеутска област:

MINERALOCORTICOID (ALDOSTERONE) RECEPTOR ANTAGONISTS

Резиме производа:

Active ingredient group (AIG) number: 0240086003; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2015-11-13

Карактеристике производа

AURO-IRBESARTAN HCT PRODUCT MONOGRAPH PAGE 1 OF 54
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-IRBESARTAN HCT
Irbesartan and hydrochlorothiazide Tablets
Tablets, 150/12.5, mg 300/12.5 mg and 300/25 mg, Oral
Manufacturer’s Standard
Angiotensin II AT
1
Receptor Blocker / Diuretic
Submission Control Number: 273508
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8 Canada.
Date of Initial Authorization:
November 13, 2015
Date of Revision:
June 19, 2023
AURO-IRBESARTAN HCT PRODUCT MONOGRAPH PAGE 2 OF 54
RECENT MAJOR LABEL CHANGES
7. Warnings and Precautions, Endocrine and Metabolism
06/2021
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
06/2021
7 Warnings and Precautions, Respiratory
06/2023
TABLE OF CONTENTS
RECENT MAJOR LABEL
CHANGES.............................................................................................2
TABLE OF CONTENTS
..............................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1 INDICATIONS
......................................................................................................................
4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2 CONTRAINDICATIONS
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4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
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5
4 DOSAGE AND ADMINISTRATION
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5
4.1 Dosing Considerations
...........................................................................................................