APO-LEVETIRACETAM TABLET

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

LEVETIRACETAM

Tillgänglig från:

APOTEX INC

ATC-kod:

N03AX14

INN (International namn):

LEVETIRACETAM

Dos:

500MG

Läkemedelsform:

TABLET

Sammansättning:

LEVETIRACETAM 500MG

Administreringssätt:

ORAL

Enheter i paketet:

100

Receptbelagda typ:

Prescription

Terapiområde:

MISCELLANEOUS ANTICONVULSANTS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2006-09-21

Produktens egenskaper

_APO-LEVETIRACETAM (levetiracetam tablets) _
_ _
_Page 1 of 42_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-LEVETIRACETAM
Levetiracetam Tablets
Tablets, 250 mg, 500 mg and 750 mg, Oral
USP
Antiepileptic
ATC Code: N03AX14
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
SEP 21, 2006
Date of Revision:
MAY 1, 2023
Submission Control Number: 270431
_APO-LEVETIRACETAM (levetiracetam tablets) _
_ _
_Page 2 of 42_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neurologic
05/2023
7 WARNINGS AND PRECAUTIONS, Cardiovascular
05/2023
7 WARNINGS AND PRECAUTIONS, Psychiatric
05/2023
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
.......................................