ADALAT OROS TABLET (EXTENDED-RELEASE)

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

NIFEDIPINE

Inapatikana kutoka:

BAYER INC

ATC kanuni:

C08CA05

INN (Jina la Kimataifa):

NIFEDIPINE

Kipimo:

20MG

Dawa fomu:

TABLET (EXTENDED-RELEASE)

Tungo:

NIFEDIPINE 20MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

28/98/100/500

Dawa ya aina:

Prescription

Eneo la matibabu:

DIHYDROPYRIDINES

Bidhaa muhtasari:

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

Idhini hali ya:

CANCELLED PRE MARKET

Idhini ya tarehe:

2022-06-23

Tabia za bidhaa

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