APO-LACOSAMIDE TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

LACOSAMIDE

Prieinama:

APOTEX INC

ATC kodas:

N03AX18

INN (Tarptautinis Pavadinimas):

LACOSAMIDE

Dozė:

150MG

Vaisto forma:

TABLET

Sudėtis:

LACOSAMIDE 150MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

30/100/1000

Recepto tipas:

Prescription

Gydymo sritis:

MISCELLANEOUS ANTICONVULSANTS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2018-10-01

Prekės savybės

_ _
_ _
_ _
_APO-LACOSAMIDE (Lacosamide Tablets) _
_ _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-LACOSAMIDE
Lacosamide Tablets
Tablets, 50 mg, 100 mg, 150 mg, and 200 mg, Oral
Antiepileptic
APOTEX INC.
Date of Initial Authorization:
150 Signet Drive
OCT 01, 2018
Toronto, Ontario
M9L 1T9
Date of Revision:
Submission Control Number: 271050
MAY 18, 2023
_ _
_ _
_ _
_APO-LACOSAMIDE (Lacosamide Tablets) _
_ _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
05/2023
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding
05/2023
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
...................................................... 4
4.4
Administration
....................................................................................................
6
4.5
Missed Dos