ADALAT XL TABLET (EXTENDED-RELEASE)

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

NIFEDIPINE

Предлага се от:

BAYER INC

АТС код:

C08CA05

INN (Международно Name):

NIFEDIPINE

дозиране:

20MG

Лекарствена форма:

TABLET (EXTENDED-RELEASE)

Композиция:

NIFEDIPINE 20MG

Начин на приложение:

ORAL

Броя в опаковка:

28/98

Вид предписание :

Prescription

Терапевтична област:

DIHYDROPYRIDINES

Каталог на резюме:

Active ingredient group (AIG) number: 0115253002; AHFS:

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2020-12-09

Данни за продукта

ADALAT XL
Page 1 of 34
PRODUCT MONOGRAPH
PR
ADALAT
® XL
®
Nifedipine extended-release tablets
20 mg, 30 mg and 60 mg nifedipine
Bayer Standard
Antianginal/Antihypertensive Agent
Manufactured by:
Bayer Inc.
2920 Matheson Boulevard East
Mississauga, Ontario
L4W 5R6
www.bayer.ca
Date of Revision:
July 25, 2016
Submission Control No: 194331

2016, Bayer Inc.
® TM see www.bayer.ca/tm-mc. All other trademarks are the property of
their respective
owners.
ADALAT XL
Page 2 of 34
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
...........................................................................................................
8
DRUG INTERACTIONS
.........................................................................................................
13
DOSAGE AND ADMINISTRATION
.....................................................................................
18
OVERDOSAGE
........................................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 20
STORAGE AND STABILITY
.................................................................................................
22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 22
PART
II:
SCIENTIFIC
INFORMATION
................................................................................
24
PHARMACEUTICAL INFORMATION
......