RAN-IRBESARTAN HCTZ TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

IRBESARTAN; HYDROCHLOROTHIAZIDE

Доступна з:

RANBAXY PHARMACEUTICALS CANADA INC.

Код атс:

C09DA04

ІПН (Міжнародна Ім'я):

IRBESARTAN AND DIURETICS

Дозування:

300MG; 25MG

Фармацевтична форма:

TABLET

Склад:

IRBESARTAN 300MG; HYDROCHLOROTHIAZIDE 25MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100

Тип рецепту:

Prescription

Терапевтична области:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Огляд продуктів:

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

Статус Авторизація:

CANCELLED POST MARKET

Дата Авторизація:

2022-07-12

Характеристики продукта

_ _
_RAN-Irbesartan HCTZ _
_Page 1 of 40_
PRODUCT MONOGRAPH
PR
RAN™-IRBESARTAN HCTZ
IRBESARTAN/HYDROCHLOROTHIAZIDE
TABLETS, 150/12.5 MG, 300/12.5 MG AND 300/25 MG
HOUSE STANDARD
ANGIOTENSIN II AT
1 RECEPTOR BLOCKER / DIURETIC
Ranbaxy Pharmaceuticals Canada Inc.
Date of Revision:
126 East Drive December 7, 2018
Brampton, Ontario
L6T 1C1
SUBMISSION CONTROL NO.: 222307
_ _
_RAN-Irbesartan HCTZ _
_Page 2 of 40_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY PRODUCT
INFORMATION.................................................................................
3
INDICATIONS AND CLINICAL USE
......................................................................................
3
CONTRAINDICATIONS
............................................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................................
4
ADVERSE REACTIONS
............................................................................................................
8
DRUG
INTERACTIONS...........................................................................................................
13
DOSAGE AND ADMINISTRATION
......................................................................................
18
OVERDOSAGE
.........................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
20
STORAGE AND STABILITY
..................................................................................................
23
DOSAGE FORMS, COMPOSITION AND
PACKAGING...................................................... 23
PART II: SCIENTIFIC
INFORMATION.................................................................................
24
PHARMACEUTICAL INFORMATION
.............................................................