ACH-LACOSAMIDE TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

LACOSAMIDE

Disponibbli minn:

ACCORD HEALTHCARE INC

Kodiċi ATC:

N03AX18

INN (Isem Internazzjonali):

LACOSAMIDE

Dożaġġ:

200MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

LACOSAMIDE 200MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

15G/50G

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

MISCELLANEOUS ANTICONVULSANTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0152810004; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2019-06-10

Karatteristiċi tal-prodott

_Product Monograph_
_-ACH-LACOSAMIDE _
_ Page 1 of 42_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ACH-LACOSAMIDE
lacosamide tablets
Tablets, 50 mg, 100 mg, 150 mg, 200 mg, Oral
Antiepileptic
ATC Code: N03AX18
Accord Healthcare Inc.
3535 boul. St. Charles, Suite 704
Kirkland, QC, H9H 5B9
Canada
Date of Initial Authorization:
June 10, 2019
Date of Revision:
January 24, 2023
Submission Control Number: 269505
_Product Monograph_
_-ACH-LACOSAMIDE _
_ Page 2 of 42_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.1 Pregnant Women
12/2022
7 Warnings and Precautions, 7.1.2 Breast-feeding
12/2022
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
....................................................................................