ENALAPRIL MALEATE/HCTZ TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

Disponível em:

AA PHARMA INC

Código ATC:

C09BA02

DCI (Denominação Comum Internacional):

ENALAPRIL AND DIURETICS

Dosagem:

5MG; 12.5MG

Forma farmacêutica:

TABLET

Composição:

ENALAPRIL MALEATE 5MG; HYDROCHLOROTHIAZIDE 12.5MG

Via de administração:

ORAL

Unidades em pacote:

100

Tipo de prescrição:

Prescription

Área terapêutica:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Resumo do produto:

Active ingredient group (AIG) number: 0217290002; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2010-06-11

Características técnicas

_ENALAPRIL MALEATE / HCTZ_
_(enalapril maleate and hydrochlorothiazide tablets) _
_Page 1 of 61_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ENALAPRIL MALEATE / HCTZ
(Enalapril Maleate and Hydrochlorothiazide Tablets)
Tablets 5 mg /12.5 mg and 10 mg /25 mg, oral
USP
Angiotensin Converting Enzyme Inhibitor / Diuretic
AA PHARMA INC.
1165 Creditstone Road, Unit#1
Vaughan, Ontario
L4K 4N7
Date of Initial Authorization:
DEC 28, 2017
Date of Revision:
MAY 10, 2023
Submission Control Number: 270203
_ENALAPRIL MALEATE / HCTZ_
_(enalapril maleate and hydrochlorothiazide tablets) _
_Page 1 of 61_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.1 Pediatrics
05/2023
1 INDICATIONS, 1.2 Geriatrics
05/2023
2 CONTRAINDICATIONS
05/
2023
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
05/2023
4 DOSAGE AND ADMINISTRATION, 4.5 Missed dose
05/2023
7 WARNINGS AND PRECAUTIONS
05/2023
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
..........