NIMOTOP TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

NIMODIPINE

Verfügbar ab:

BAYER INC

ATC-Code:

C08CA06

INN (Internationale Bezeichnung):

NIMODIPINE

Dosierung:

30MG

Darreichungsform:

TABLET

Zusammensetzung:

NIMODIPINE 30MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100

Verschreibungstyp:

Prescription

Therapiebereich:

DIHYDROPYRIDINES

Produktbesonderheiten:

Active ingredient group (AIG) number: 0116077001; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2009-05-07

Fachinformation

_Page 1 of 27 _
PRODUCT MONOGRAPH
PR
NIMOTOP
® TABLETS
nimodipine tablets Bayer Standard
30 mg
Adjunct in the Management of
Subarachnoid Hemorrhage
Calcium Channel Blocking Agent
Bayer Inc.
77 Belfield Road
Toronto, Ontario
M9W 1G6
Canada
www.bayer.ca
Date of Revision :
November 1, 2011
Submission Control No.: 148221
© 2011, Bayer Inc.
® NIMOTOP is a registered trademark of Bayer AG, used under license
by Bayer Inc.
_Page 2 of 27 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL
USE..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND
PRECAUTIONS..................................................................................4
ADVERSE
REACTIONS....................................................................................................6
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND
ADMINISTRATION..............................................................................10
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND
STABILITY..........................................................................................15
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................15
PART II: SCIENTIFIC INFORMATION
................................................................................16
PHARMACEUTICAL
INFORMATION..........................................................................16
CLINICAL
TRIALS.....................................................