ENALAPRIL MALEATE/HCTZ TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE

Dostupno od:

AA PHARMA INC

ATC koda:

C09BA02

INN (International ime):

ENALAPRIL AND DIURETICS

Doziranje:

5MG; 12.5MG

Farmaceutski oblik:

TABLET

Sastav:

ENALAPRIL MALEATE 5MG; HYDROCHLOROTHIAZIDE 12.5MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2010-06-11

Svojstava lijeka

_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
..........