APO-ENALAPRIL TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

ENALAPRIL MALEATE

Fáanlegur frá:

APOTEX INC

ATC númer:

C09AA02

INN (Alþjóðlegt nafn):

ENALAPRIL

Skammtar:

5MG

Lyfjaform:

TABLET

Samsetning:

ENALAPRIL MALEATE 5MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100 & 500 TABLETS

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Vörulýsing:

Active ingredient group (AIG) number: 0117649003; AHFS:

Leyfisstaða:

MARKETED

Leyfisdagur:

1993-12-31

Vara einkenni

_APO-ENALAPRIL (Enalapril Maleate Tablets_)
_Page 1 of 48_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-ENALAPRIL
Enalapril Maleate Tablets
Tablets 2.5 mg, 5 mg, 10 mg, and 20 mg, oral
USP
Angiotensin Converting Enzyme Inhibitor
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
JUN 11, 2010
Date of Revision:
MAY 11, 2023
Submission Control Number: 270097
_APO-ENALAPRIL (Enalapril Maleate Tablets_)
_Page 2 of 48_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
05/2023
4 DOSAGE AND ADMINISTRATION
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
...............................................................................
5
4.1 Dosing Considerations
.............................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
........................................................ 5
4.4 Administration
..........................................