SANDOZ LEVETIRACETAM TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

LEVETIRACETAM

Tilgængelig fra:

SANDOZ CANADA INCORPORATED

ATC-kode:

N03AX14

INN (International Name):

LEVETIRACETAM

Dosering:

250MG

Lægemiddelform:

TABLET

Sammensætning:

LEVETIRACETAM 250MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

MISCELLANEOUS ANTICONVULSANTS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2017-03-03

Produktets egenskaber

_Sandoz Levetiracetam _
_Page 1 of 39_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SANDOZ® LEVETIRACETAM
Levetiracetam Tablets
Tablets, 250 mg, 500 mg, 750 mg, 1000 mg, Oral
Manufacturer’s Standard
Antiepileptic
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, Québec
J4B 1E6
Date of Initial Authorization:
March 3, 2017
Date of Revision:
September 13, 2023
Submission Control Number: 275484
_Sandoz Levetiracetam _
_Page 2 of 39_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neurologic
09/2023
7 WARNINGS AND PRECAUTIONS, Psychiatric
09/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.................................................................................................
2
TABLE OF CONTENTS
...................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
...........................................................................
4
1
INDICATIONS
........................................................................................................................
4
1.1
Pediatrics
........................................................................................................................
4
1.2
Geriatrics
.........................................................................................................................
4
2
CONTRAINDICATIONS
..........................................................................................................
4
4
DOSAGE AND ADMINISTRATION
..........................................................................................
4
4.1
Dosing
Considerations.....................................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
................................................................ 4
4.4
Administration
.........................................................