TELMISARTAN-HCTZ TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

TELMISARTAN; HYDROCHLOROTHIAZIDE

Dostupné z:

PRO DOC LIMITEE

ATC kód:

C09DA07

INN (Medzinárodný Name):

TELMISARTAN AND DIURETICS

Dávkovanie:

80MG; 25MG

Forma lieku:

TABLET

Zloženie:

TELMISARTAN 80MG; HYDROCHLOROTHIAZIDE 25MG

Spôsob podávania:

ORAL

Počet v balení:

30/100

Typ predpisu:

Prescription

Terapeutické oblasti:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Prehľad produktov:

Active ingredient group (AIG) number: 0244783002; AHFS:

Stav Autorizácia:

MARKETED

Dátum Autorizácia:

2012-11-22

Súhrn charakteristických

_ Telmisartan-HCTZ _
_Page 1 of 61_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TELMISARTAN-HCTZ
Telmisartan/Hydrochlorothiazide Tablets
Tablet, 80 mg / 12.5 mg and 80 mg / 25 mg, Oral
USP
Angiotensin II AT
1
Receptor Blocker/Diuretic
PRO DOC LTÉE.
2925, boul. Industriel
Laval, Quebec
H7L 3W9
Submission Control Number: 270403
Date of Initial Authorization:
NOV 01, 2012
Date of Revision:
JAN 9, 2023
_ Telmisartan-HCTZ _
_Page 2 of 61_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
05/2022
4 DOSAGE AND ADMINISTRATION
01/2023
7 WARNINGS AND PRECAUTIONS
01/2023
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
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4
2 CONTRAINDICATIONS
......................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................. 5
4
DOSAGE AND ADMINISTRATION
......................................................................................
5
4.1 Dosing Considerations
.................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
.........................................