LEVETIRACETAM TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

LEVETIRACETAM

Dostupno od:

SANIS HEALTH INC

ATC koda:

N03AX14

INN (International ime):

LEVETIRACETAM

Doziranje:

1000MG

Farmaceutski oblik:

TABLET

Sastav:

LEVETIRACETAM 1000MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Proizvod sažetak:

Active ingredient group (AIG) number: 0148843004; AHFS:

Status autorizacije:

APPROVED

Datum autorizacije:

2022-10-17

Svojstava lijeka

_LEVETIRACETAM _
_Page 1 of 39_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LEVETIRACETAM
Levetiracetam Tablets
Tablets, 250 mg, 500 mg, 750 mg, 1000 mg, Oral
Manufacturer’s Standard
Antiepileptic
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Submission Control Number: 267520
Date of Initial Authorization:
JUN 16, 2010
Date of
Revision:
OCT 14, 2022
_LEVETIRACETAM _
_Page 2 of 39_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neurologic
10/2022
7 WARNINGS AND PRECAUTIONS, Cardiovascular
10/2022
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
.................................................................................