ABBOTT-LEVETIRACETAM TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

LEVETIRACETAM

Tilgængelig fra:

ABBOTT LABORATORIES, LIMITED

ATC-kode:

N03AX14

INN (International Name):

LEVETIRACETAM

Dosering:

500MG

Lægemiddelform:

TABLET

Sammensætning:

LEVETIRACETAM 500MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

MISCELLANEOUS ANTICONVULSANTS

Produkt oversigt:

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

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2015-12-31

Produktets egenskaber

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