TEVA-VALSARTAN/HCTZ TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

VALSARTAN; HYDROCHLOROTHIAZIDE

Предлага се от:

TEVA CANADA LIMITED

АТС код:

C09DA03

INN (Международно Name):

VALSARTAN AND DIURETICS

дозиране:

160MG; 25MG

Лекарствена форма:

TABLET

Композиция:

VALSARTAN 160MG; HYDROCHLOROTHIAZIDE 25MG

Начин на приложение:

ORAL

Броя в опаковка:

30/50/100/500

Вид предписание :

Prescription

Терапевтична област:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Каталог на резюме:

Active ingredient group (AIG) number: 0240204003; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2011-02-16

Данни за продукта

_TEVA-VALSARTAN/HCTZ (Valsartan and Hydrochlorothiazide Tablets)_
_ _
_Page 1 of 60_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TEVA-VALSARTAN/HCTZ
Valsartan and Hydrochlorothiazide Tablets
Tablets, 80 mg/12.5 mg, 160 mg/12.5 mg, 160 mg/25 mg,
320 mg/12.5 mg and 320 mg/25 mg, Oral
Angiotensin II AT
1
Receptor Blocker and Diuretic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Initial Authorization:
February 16, 2011
Date of Revision:
December 12, 2023
Submission Control Number: 275824
_TEVA-VALSARTAN/HCTZ (Valsartan and Hydrochlorothiazide Tablets)_
_ _
_Page 2 of 60_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Driving and
Operating Machinery
12/2023
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
12/2023
7 WARNINGS AND PRECAUTIONS, Respiratory
12/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1 Pediatrics (< 18 years of age):
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4
1.2 Geriatrics (> 65 years of age):
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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5
4.1 Dosing Considerations
...