TEVA-IRBESARTAN HCTZ TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

IRBESARTAN; HYDROCHLOROTHIAZIDE

Dostupno od:

TEVA CANADA LIMITED

ATC koda:

C09DA04

INN (International ime):

IRBESARTAN AND DIURETICS

Doziranje:

150MG; 12.5MG

Farmaceutski oblik:

TABLET

Sastav:

IRBESARTAN 150MG; HYDROCHLOROTHIAZIDE 12.5MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Proizvod sažetak:

Active ingredient group (AIG) number: 0240086001; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2018-06-13

Svojstava lijeka

_Product Monograph – TEVA-IRBESARTAN HCTZ Page 1 of 52 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-IRBESARTAN HCTZ
Irbesartan and Hydrochlorothiazide Tablets
Tablets, 150/12.5mg, 300/12.5mg and 300/25mg, Oral
Teva Standard
Angiotensin II AT
1
Receptor Blocker/ Diuretic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9, Canada
Date of initial Authorization:
July 8, 2009
Date of Revision:
June 19, 2023
www.tevacanada.com
Submission Control No: 273241
_Product Monograph – TEVA-IRBESARTAN HCTZ Page 2 of 52 _
RECENT MAJOR LABEL CHANGES
7. Warnings and Precautions, Endocrine and Metabolism
06/2023
7. Warnings and Precautions, Ophthalmologic
06/2023
7. Warnings and Precautions, Respiratory
06/2023
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
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
......................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.................................................. 5
4.3
Administration
......................