COVERSYL TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

PERINDOPRIL ERBUMINE

MAH:

SERVIER CANADA INC

ATC_code:

C09AA04

INN:

PERINDOPRIL

dosage:

8MG

pharmaceutical_form:

TABLET

composition:

PERINDOPRIL ERBUMINE 8MG

administration_route:

ORAL

units_in_package:

30

prescription_type:

Prescription

therapeutic_area:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

leaflet_short:

Active ingredient group (AIG) number: 0127178003; AHFS:

authorization_status:

APPROVED

authorization_date:

2002-10-16

SPC

_ _
_COVERSYL_
_®_
_ (perindopril erbumine) Product Monograph _
_Page 1 of 63_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
COVERSYL®
Perindopril erbumine Tablets
Tablets, 2 mg, 4 mg and 8 mg, Oral
Angiotensin Converting Enzyme Inhibitor
Servier Canada Inc.
3224 Avenue Jean-Béraud #270
Laval, Quebec H7T 2S4
Canada
Date of Initial Authorization:
June 6, 1994
Date of Revision:
October 21, 2022
Submission Control Number: 264109
_ _
_COVERSYL_
_®_
_ (perindopril erbumine) Product Monograph _
_Page 2 of 63_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
[10/2022]
7 WARNING AND PRECAUTIONS
[10/2022]
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 (< 18 years of
age)................................................................................4
1.2
Geriatrics (>65 years of
age).................................................................................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.................