ADALAT XL TABLET (EXTENDED-RELEASE)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

NIFEDIPINE

Διαθέσιμο από:

BAYER INC

Φαρμακολογική κατηγορία (ATC):

C08CA05

INN (Διεθνής Όνομα):

NIFEDIPINE

Δοσολογία:

20MG

Φαρμακοτεχνική μορφή:

TABLET (EXTENDED-RELEASE)

Σύνθεση:

NIFEDIPINE 20MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

28/98

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

DIHYDROPYRIDINES

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2020-12-09

Αρχείο Π.Χ.Π.

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
......