RIVA-PERINDOPRIL TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

PERINDOPRIL ERBUMINE

Доступна з:

LABORATOIRE RIVA INC.

Код атс:

C09AA04

ІПН (Міжнародна Ім'я):

PERINDOPRIL

Дозування:

4MG

Фармацевтична форма:

TABLET

Склад:

PERINDOPRIL ERBUMINE 4MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

30/100

Тип рецепту:

Prescription

Терапевтична области:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2018-03-07

Характеристики продукта

_RIVA-PERINDOPRIL (Perindopril Erbumine Tablets) _
_ _
_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) _
_ _
_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
.................................