AURO-TELMISARTAN HCTZ TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

TELMISARTAN; HYDROCHLOROTHIAZIDE

Prieinama:

AURO PHARMA INC

ATC kodas:

C09DA07

INN (Tarptautinis Pavadinimas):

TELMISARTAN AND DIURETICS

Dozė:

80MG; 12.5MG

Vaisto forma:

TABLET

Sudėtis:

TELMISARTAN 80MG; HYDROCHLOROTHIAZIDE 12.5MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

30/100/500/1000

Recepto tipas:

Prescription

Gydymo sritis:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2016-07-18

Prekės savybės

_Auro-Telmisartan HCTZ Product Monograph _Page 1 of 64
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-TELMISARTAN HCTZ
Telmisartan and Hydrochlorothiazide Tablets, USP
Tablet, 80 mg/12.5 mg and 80 mg/25 mg, Oral
Angiotensin II AT
1
Receptor Blocker/ Diuretic
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date of initial Authorization:
July 18, 2016
Date of Revision:
January 26, 2023
Submission Control No: 267665
_Auro-Telmisartan HCTZ Product Monograph _Page 2 of 64
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
01 / 2023
7 WARNINGS AND PRECAUTIONS
01 / 2023
4 DOSAGE AND ADMINISTRATION
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
............................................................................................................................................
4
2 CONTRAINDICATIONS
...........................................................................................................
4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
.......................................................................
5
4 DOSAGE AND ADMINISTRATION
...........................................................................................
5
4.1 Dosing Considerations
...................................................