APO-PERINDOPRIL ARGININE TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

PERINDOPRIL ARGININE

Доступна з:

APOTEX INC

Код атс:

C09AA04

ІПН (Міжнародна Ім'я):

PERINDOPRIL

Дозування:

10MG

Фармацевтична форма:

TABLET

Склад:

PERINDOPRIL ARGININE 10MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

30/100/500/1000

Тип рецепту:

Prescription

Терапевтична области:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Огляд продуктів:

Active ingredient group (AIG) number: 0151321003; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2018-03-09

Характеристики продукта

_APO-PERINDOPRIL ARGININE PRODUCT MONOGRAPH _
_Page 1 of 68_
_ _
PRODUCT MONOGRAPH
PR
APO-PERINDOPRIL ARGININE
Perindopril Arginine Tablets
2.5 mg, 5 mg and 10 mg
Angiotensin Converting Enzyme Inhibitor
APOTEX INC.
DATE OF PREPARATION:
150 SIGNET DRIVE
April 24, 2019
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 223805
_APO-PERINDOPRIL ARGININE PRODUCT MONOGRAPH _
_Page 2 of 68_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
14
DRUG INTERACTIONS
.........................................................................................................
21
DOSAGE AND ADMINISTRATION
.....................................................................................
25
OVERDOSAGE
........................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
28
STORAGE AND STABILITY
.................................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 32
PART II: SCIENTIFIC INFORMATION
...............................................................................
34
PHARMACEUTICAL INFORM