TEVA-VALSARTAN/HCTZ TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

VALSARTAN; HYDROCHLOROTHIAZIDE

Beschikbaar vanaf:

TEVA CANADA LIMITED

ATC-code:

C09DA03

INN (Algemene Internationale Benaming):

VALSARTAN AND DIURETICS

Dosering:

160MG; 12.5MG

farmaceutische vorm:

TABLET

Samenstelling:

VALSARTAN 160MG; HYDROCHLOROTHIAZIDE 12.5MG

Toedieningsweg:

ORAL

Eenheden in pakket:

30/50/100/500

Prescription-type:

Prescription

Therapeutisch gebied:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Product samenvatting:

Active ingredient group (AIG) number: 0240204002; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2011-02-16

Productkenmerken

_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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1
INDICATIONS
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4
1.1 Pediatrics (< 18 years of age):
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1.2 Geriatrics (> 65 years of age):
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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
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