ABBOTT-LEVETIRACETAM TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

LEVETIRACETAM

Verfügbar ab:

ABBOTT LABORATORIES, LIMITED

ATC-Code:

N03AX14

INN (Internationale Bezeichnung):

LEVETIRACETAM

Dosierung:

250MG

Darreichungsform:

TABLET

Zusammensetzung:

LEVETIRACETAM 250MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100

Verschreibungstyp:

Prescription

Therapiebereich:

MISCELLANEOUS ANTICONVULSANTS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0148843001; AHFS:

Berechtigungsstatus:

CANCELLED POST MARKET

Berechtigungsdatum:

2015-12-31

Fachinformation

_ _
_Abbott-Levetiracetam Product Monograph _
_Page 1 of 33_
PRODUCT MONOGRAPH
PR
ABBOTT-LEVETIRACETAM
Levetiracetam Tablets USP
250 mg, 500 mg and 750 mg
Antiepileptic Agent
Abbott Laboratories, Limited
8401 Trans-Canada Highway
Saint-Laurent, Quebec
H4S 1Z1
Control No.: 183151
Date of Preparation:
November 1, 2013
Date of Revision:
March 27, 2015
_ _
_Abbott-Levetiracetam Product Monograph _
_Page 2 of 33 _
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
....................................................................................................7
DRUG INTERACTIONS
................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................13
OVERDOSAGE
................................................................................................................15
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................18
PART II: SCIENTIFIC INFORMATION
...............................................................................20
PHARMACEUTICAL INFORMATION
..........................................................................20
CLINICAL TRIALS
............................................................................