RIVA-PERINDOPRIL TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

PERINDOPRIL ERBUMINE

Beschikbaar vanaf:

LABORATOIRE RIVA INC.

ATC-code:

C09AA04

INN (Algemene Internationale Benaming):

PERINDOPRIL

Dosering:

4MG

farmaceutische vorm:

TABLET

Samenstelling:

PERINDOPRIL ERBUMINE 4MG

Toedieningsweg:

ORAL

Eenheden in pakket:

30/100

Prescription-type:

Prescription

Therapeutisch gebied:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Product samenvatting:

Active ingredient group (AIG) number: 0127178002; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2018-03-07

Productkenmerken

_RIVA-PERINDOPRIL (Perindopril Erbumine Tablets) _
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_Page 1 of 65_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RIVA-PERINDOPRIL
Perindopril Erbumine Tablets
Tablets, 2 mg, 4 mg and 8 mg, Oral
USP
Angiotensin Converting Enzyme Inhibitor
LABORATOIRE RIVA INC.
660 Boul.
Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Submission Control No.: 276450
Date of Initial Authorization:
MAR 7, 2018
Date of Revision:
JUL 13, 2023
_RIVA-PERINDOPRIL (Perindopril Erbumine Tablets) _
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_Page 2 of 65_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
7 WARNING AND PRECAUTIONS
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
......................................................... 6
4.4
Administration
.................................