MINT-LACOSAMIDE TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

LACOSAMIDE

Dostupné s:

MINT PHARMACEUTICALS INC

ATC kód:

N03AX18

INN (Mezinárodní Name):

LACOSAMIDE

Dávkování:

50MG

Léková forma:

TABLET

Složení:

LACOSAMIDE 50MG

Podání:

ORAL

Jednotky v balení:

15G/50G

Druh předpisu:

Prescription

Terapeutické oblasti:

MISCELLANEOUS ANTICONVULSANTS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2019-07-15

Charakteristika produktu

_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