JAMP-LACOSAMIDE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

LACOSAMIDE

Saatavilla:

JAMP PHARMA CORPORATION

ATC-koodi:

N03AX18

INN (Kansainvälinen yleisnimi):

LACOSAMIDE

Annos:

150MG

Lääkemuoto:

TABLET

Koostumus:

LACOSAMIDE 150MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Terapeuttinen alue:

MISCELLANEOUS ANTICONVULSANTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2019-05-10

Valmisteyhteenveto

_JAMP-Lacosamide Product Monograph _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_Page 1 of 47 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP-LACOSAMIDE
Lacosamide Tablets
Tablets, 50 mg, 100 mg, 150 mg, 200 mg, Oral
Antiepileptic
ATC Code: N03AX18
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Quebec.
J4B 5H3,Canada
Date of Initial Authorization:
May 8, 2019
Date of Revision:
December 8, 2022
Submission Control Number: 265635
_JAMP-Lacosamide Product Monograph _
_ _
_ _
_ _
_ _
_ _
_ _
_ _
_Page 2 of 47 _
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...................................................... 5
4.4
Administration.........................................................