APO-PERINDOPRIL/AMLODIPINE TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

PERINDOPRIL ARGININE; AMLODIPINE (AMLODIPINE BESYLATE)

Доступна з:

APOTEX INC

Код атс:

C09BB04

ІПН (Міжнародна Ім'я):

PERINDOPRIL AND AMLODIPINE

Дозування:

7MG; 5MG

Фармацевтична форма:

TABLET

Склад:

PERINDOPRIL ARGININE 7MG; AMLODIPINE (AMLODIPINE BESYLATE) 5MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

30/100/500

Тип рецепту:

Prescription

Терапевтична области:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Огляд продуктів:

Active ingredient group (AIG) number: 0257790002; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2019-05-09

Характеристики продукта

_APO-PERINDOPRIL/AMLODIPINE (Perindopril arginine and Amlodipine) _
_Page 1 of 62 _
_ _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-PERINDOPRIL/AMLODIPINE
Perindopril Arginine and Amlodipine Tablets
Tablets, 3.5 mg Perindopril arginine / 2.5 mg Amlodipine (as
amlodipine besylate), Oral
Tablets, 7 mg Perindopril arginine / 5 mg Amlodipine (as amlodipine
besylate), Oral
Tablets, 14 mg Perindopril arginine / 10 mg Amlodipine (as amlodipine
besylate), Oral
Angiotensin converting enzyme inhibitor / Dihydropyridine calcium
antagonist
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
MAY 09, 2019
Date of Revision:
OCT 11, 2023
Submission Control Number: 275887
_APO-PERINDOPRIL/AMLODIPINE (Perindopril arginine and Amlodipine) _
_Page 2 of 62 _
_ _
_ _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
10/2023
7 WARNING AND PRECAUTIONS
10/2023
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 (<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
.................