APO-LEVETIRACETAM TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

LEVETIRACETAM

Tilgjengelig fra:

APOTEX INC

ATC-kode:

N03AX14

INN (International Name):

LEVETIRACETAM

Dosering :

500MG

Legemiddelform:

TABLET

Sammensetning:

LEVETIRACETAM 500MG

Administreringsrute:

ORAL

Enheter i pakken:

100

Resept typen:

Prescription

Terapeutisk område:

MISCELLANEOUS ANTICONVULSANTS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2006-09-21

Preparatomtale

_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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
..................................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.1
Dosing Considerations
................................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................... 4
4.4
Administration
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