ABBOTT-LEVETIRACETAM TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

LEVETIRACETAM

Disponible depuis:

ABBOTT LABORATORIES, LIMITED

Code ATC:

N03AX14

DCI (Dénomination commune internationale):

LEVETIRACETAM

Dosage:

500MG

forme pharmaceutique:

TABLET

Composition:

LEVETIRACETAM 500MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

MISCELLANEOUS ANTICONVULSANTS

Descriptif du produit:

Active ingredient group (AIG) number: 0148843002; AHFS:

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2015-12-31

Résumé des caractéristiques du produit

_ _
_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
............................................................................