TEVETEN PLUS TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

EPROSARTAN (EPROSARTAN MESYLATE); HYDROCHLOROTHIAZIDE

Disponível em:

BGP PHARMA ULC

Código ATC:

C09DA02

DCI (Denominação Comum Internacional):

EPROSARTAN AND DIURETICS

Dosagem:

600MG; 12.5MG

Forma farmacêutica:

TABLET

Composição:

EPROSARTAN (EPROSARTAN MESYLATE) 600MG; HYDROCHLOROTHIAZIDE 12.5MG

Via de administração:

ORAL

Unidades em pacote:

7/28

Tipo de prescrição:

Prescription

Área terapêutica:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Resumo do produto:

Active ingredient group (AIG) number: 0250121001; AHFS:

Status de autorização:

CANCELLED POST MARKET

Data de autorização:

2023-09-18

Características técnicas

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_TEVETEN_
_®_
_ PLUS, eprosartan mesylate / hydrochlorothiazide Product Monograph _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
TEVETEN® PLUS
eprosartan mesylate / hydrochlorothiazide
Tablets, 600 mg eprosartan / 12.5 mg hydrochlorothiazide, Oral
Angiotensin II Receptor (AT1) Antagonist and Diuretic
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Initial Authorization:
JUN 08, 2004
Date of Revision:
SEP 26, 2022
Submission Control Number: 263867
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_TEVETEN_
_®_
_ PLUS, eprosartan mesylate / hydrochlorothiazide Product Monograph _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
07/2020
7 WARNINGS AND PRECAUTIONS, Ophthalmologic
02/2021
7 WARNINGS AND PRECAUTIONS, Respiratory
09/2022
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
............................