MAR-LACOSAMIDE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

LACOSAMIDE

Mevcut itibaren:

MARCAN PHARMACEUTICALS INC

ATC kodu:

N03AX18

INN (International Adı):

LACOSAMIDE

Doz:

150MG

Farmasötik formu:

TABLET

Kompozisyon:

LACOSAMIDE 150MG

Uygulama yolu:

ORAL

Paketteki üniteler:

250ML

Reçete türü:

Prescription

Terapötik alanı:

MISCELLANEOUS ANTICONVULSANTS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2019-04-26

Ürün özellikleri

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
...............