PHARMA-LACOSAMIDE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

LACOSAMIDE

Sẵn có từ:

PHARMASCIENCE INC

Mã ATC:

N03AX18

INN (Tên quốc tế):

LACOSAMIDE

Liều dùng:

100MG

Dạng dược phẩm:

TABLET

Thành phần:

LACOSAMIDE 100MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

60

Loại thuốc theo toa:

Prescription

Khu trị liệu:

MISCELLANEOUS ANTICONVULSANTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0152810002; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2018-10-01

Đặc tính sản phẩm

______________________________________________________________________________
_pharma-LACOSAMIDE Product Monograph_
_ Page 1 of 44_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PHARMA-LACOSAMIDE
Lacosamide Tablets
Tablets; 50 mg, 100 mg, 150 mg and 200 mg, Oral
Ph.Eur.
Antiepileptic Agent
ATC Code: N03AX18
PHARMASCIENCE INC.:
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control Number: 273596
Date of Initial
Authorization:
OCT
1, 2018
Date of Revision:
APR
14, 2023
______________________________________________________________________________
_pharma-LACOSAMIDE Product Monograph_
_ Page 2 of 44_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.1 Pregnant Women
04/2023
7 Warnings and Precautions, 7.1.2 Breast-feeding
04/2023
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
Recommende