MAR-LACOSAMIDE TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

LACOSAMIDE

Disponível em:

MARCAN PHARMACEUTICALS INC

Código ATC:

N03AX18

DCI (Denominação Comum Internacional):

LACOSAMIDE

Dosagem:

150MG

Forma farmacêutica:

TABLET

Composição:

LACOSAMIDE 150MG

Via de administração:

ORAL

Unidades em pacote:

250ML

Tipo de prescrição:

Prescription

Área terapêutica:

MISCELLANEOUS ANTICONVULSANTS

Resumo do produto:

Active ingredient group (AIG) number: 0152810003; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2019-04-26

Características técnicas

Page 1 of 48
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MAR-LACOSAMIDE
Lacosamide
Film-coated tablets, 50 mg, 100 mg, 150 mg, 200 mg lacosamide, Oral
Mfr. Std
Antiepileptic
ATC Code: N03AX18
Marcan Pharmaceuticals Inc.
2 Gurdwara Road,
Suite #112, Ottawa
ON K2E 1A2
Date of Initial Authorization:
APR 24, 2019
Date of Revision:
JAN 19, 2023
Submission Control Number: 271089
_Page 2 of 48 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.1 Pregnant Women
01/2023
7 Warnings and Precautions, 7.1.2 Breast-feeding
01/2023
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
.......................................................... 5
4.4
Administration
...........................................................................................................
6
4.5
Missed Dose
...............