MINT-LACOSAMIDE TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

LACOSAMIDE

Dostopno od:

MINT PHARMACEUTICALS INC

Koda artikla:

N03AX18

INN (mednarodno ime):

LACOSAMIDE

Odmerek:

150MG

Farmacevtska oblika:

TABLET

Sestava:

LACOSAMIDE 150MG

Pot uporabe:

ORAL

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

MISCELLANEOUS ANTICONVULSANTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0152810003; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2019-07-15

Lastnosti izdelka

_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