ADALAT OROS TABLET (EXTENDED-RELEASE)

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

NIFEDIPINE

Sẵn có từ:

BAYER INC

Mã ATC:

C08CA05

INN (Tên quốc tế):

NIFEDIPINE

Liều dùng:

60MG

Dạng dược phẩm:

TABLET (EXTENDED-RELEASE)

Thành phần:

NIFEDIPINE 60MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

28/98/100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

DIHYDROPYRIDINES

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0115253005; AHFS:

Tình trạng ủy quyền:

CANCELLED PRE MARKET

Ngày ủy quyền:

2022-06-23

Đặc tính sản phẩm

ADALAT OROS
Page 1 of 34
PRODUCT MONOGRAPH
PR
ADALAT
® OROS
®
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:
September 29, 2016
Submission Control No: 198159

2016, Bayer Inc.
® TM see www.bayer.ca/tm-mc. All other trademarks are the property of
their respective
owners.
ADALAT OROS
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 INFORMA