ADALAT OROS TABLET (EXTENDED-RELEASE)

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

NIFEDIPINE

Disponible des:

BAYER INC

Codi ATC:

C08CA05

Designació comuna internacional (DCI):

NIFEDIPINE

Dosis:

30MG

formulario farmacéutico:

TABLET (EXTENDED-RELEASE)

Composición:

NIFEDIPINE 30MG

Vía de administración:

ORAL

Unidades en paquete:

28/98/100/500

tipo de receta:

Prescription

Área terapéutica:

DIHYDROPYRIDINES

Resumen del producto:

Active ingredient group (AIG) number: 0115253004; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2009-03-13

Fitxa tècnica

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