LACOSAMIDE TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

LACOSAMIDE

から入手可能:

SANIS HEALTH INC

ATCコード:

N03AX18

INN（国際名）:

LACOSAMIDE

投薬量:

50MG

医薬品形態:

TABLET

構図:

LACOSAMIDE 50MG

投与経路:

ORAL

パッケージ内のユニット:

15G/50G

処方タイプ:

Prescription

治療領域:

MISCELLANEOUS ANTICONVULSANTS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2021-02-25

製品の特徴

_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
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4
2 CONTRAINDICATIONS
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4
4 DOSAGE AND ADMINISTRATION
.........................................................................................
4
4.1 Dosing Considerations
...............................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
........................................................... 4
4.4 Administration
..........................................................