TEVA-TELMISARTAN HCTZ TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

TELMISARTAN (TELMISARTAN SODIUM); HYDROCHLOROTHIAZIDE

Dostępny od:

TEVA CANADA LIMITED

Kod ATC:

C09DA07

INN (International Nazwa):

TELMISARTAN AND DIURETICS

Dawkowanie:

80MG; 12.5MG

Forma farmaceutyczna:

TABLET

Skład:

TELMISARTAN (TELMISARTAN SODIUM) 80MG; HYDROCHLOROTHIAZIDE 12.5MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30/100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0244783001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2012-02-06

Charakterystyka produktu

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TEVA-TELMISARTAN HCTZ
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Page 1 of 72
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-TELMISARTAN HCTZ
Telmisartan and Hydrochlorothiazide Tablets
Tablet, 80 mg Telmisartan (as Telmisartan Sodium) / 12.5 mg
Hydrochlorothiazide, Oral
Tablet, 80 mg Telmisartan (as Telmisartan Sodium) / 25 mg
Hydrochlorothiazide, Oral
Teva standard
Angiotensin II AT
1
Receptor Blocker / Diuretic
Teva Canada Limited
30 Novopharm Court
Toronto, ON
M1B 2K9
Canada
www.tevacanada.com
Date of Initial Authorization:
February 6, 2012
Date of Revision:
February 24, 2023
Submission Control Number: 267285
_ _
TEVA-TELMISARTAN HCTZ
_ _
Page 2 of 72
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
10/2021
7 WARNINGS AND PRECAUTIONS
02/2023
4 DOSAGE AND ADMINISTRATION
02/2023
7 WARNINGS AND PRECAUTIONS
02/2023
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
................................................................................................................
2
PART I:
HEALTH PROFESSIONAL
INFORMATION.....................................................................
4
1
INDICATIONS
....................................................................................................................
4
1.1
Pediatrics
....................................................................................................................
4
1.2
Geriatrics
....................................................................................................................
4
2
CONTRAINDICATIONS
.......................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.................................................................. 5
4
DOSAGE AND
ADMINISTRATION.......................................................................................
5
4.1
Dos