ADALAT OROS TABLET (EXTENDED-RELEASE)

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

NIFEDIPINE

Fáanlegur frá:

BAYER INC

ATC númer:

C08CA05

INN (Alþjóðlegt nafn):

NIFEDIPINE

Skammtar:

20MG

Lyfjaform:

TABLET (EXTENDED-RELEASE)

Samsetning:

NIFEDIPINE 20MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

28/98/100/500

Gerð lyfseðils:

Prescription

Lækningarsvæði:

DIHYDROPYRIDINES

Vörulýsing:

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

Leyfisstaða:

CANCELLED PRE MARKET

Leyfisdagur:

2022-06-23

Vara einkenni

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