JAMP-LACOSAMIDE TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

LACOSAMIDE

Fáanlegur frá:

JAMP PHARMA CORPORATION

ATC númer:

N03AX18

INN (Alþjóðlegt nafn):

LACOSAMIDE

Skammtar:

100MG

Lyfjaform:

TABLET

Samsetning:

LACOSAMIDE 100MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Lækningarsvæði:

MISCELLANEOUS ANTICONVULSANTS

Vörulýsing:

Active ingredient group (AIG) number: 0152810002; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2019-05-10

Vara einkenni

_JAMP-Lacosamide Product Monograph _
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_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 _
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_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.........................................................