MINT-LACOSAMIDE TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

LACOSAMIDE

זמין מ:

MINT PHARMACEUTICALS INC

קוד ATC:

N03AX18

INN (שם בינלאומי):

LACOSAMIDE

כמות:

50MG

טופס פרצבטיות:

TABLET

הרכב:

LACOSAMIDE 50MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

MISCELLANEOUS ANTICONVULSANTS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2019-07-15

מאפייני מוצר

_MINT-LACOSAMIDE, Lacosamide _
_Page 1 of 43_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MINT-LACOSAMIDE
Lacosamide Tablets
Tablets, 50 mg, 100 mg, 150 mg, 200 mg, Oral
Manufacturer’s Standard
Antiepileptic Agent
ATC Code: N03AX18
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Initial Authorization:
JUL 12, 2019
Date of Revision:
JAN 12, 2023
Submission Control Number: 266694
_ _
_MINT-LACOSAMIDE, Lacosamide _
_Page 2 of 43_
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
Miss