LACOSAMIDE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

LACOSAMIDE

Mevcut itibaren:

SANIS HEALTH INC

ATC kodu:

N03AX18

INN (International Adı):

LACOSAMIDE

Doz:

50MG

Farmasötik formu:

TABLET

Kompozisyon:

LACOSAMIDE 50MG

Uygulama yolu:

ORAL

Paketteki üniteler:

15G/50G

Reçete türü:

Prescription

Terapötik alanı:

MISCELLANEOUS ANTICONVULSANTS

Ürün özeti:

Active ingredient group (AIG) number: 0152810001; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2021-02-25

Ürün özellikleri

_LACOSAMIDE Product Monograph _Page 1 of 42
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LACOSAMIDE
Lacosamide Tablets
Film-coated tablets, 50 mg, 100 mg, 150 mg and 200 mg, Oral
House standard
Antiepileptic
ATC Code: N03AX18
SANIS HEALTH INC.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Initial Authorization:
February 25, 2021
Date of Revision:
August 24, 2023
Submission Control Number: 274418
_LACOSAMIDE Product Monograph _Page 2 of 42
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.1 Pregnant Women
08/2023
7 Warnings and Precautions, 7.1.2 Breast-feeding
08/2023
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
..........................................................