JAMP-LACOSAMIDE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

LACOSAMIDE

Dostępny od:

JAMP PHARMA CORPORATION

Kod ATC:

N03AX18

INN (International Nazwa):

LACOSAMIDE

Dawkowanie:

150MG

Forma farmaceutyczna:

TABLET

Skład:

LACOSAMIDE 150MG

Droga podania:

ORAL

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Prescription

Dziedzina terapeutyczna:

MISCELLANEOUS ANTICONVULSANTS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2019-05-10

Charakterystyka produktu

_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
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4
4
DOSAGE AND ADMINISTRATION
..................................................................................
4
4.1
Dosing Considerations
........................................................................................
4
4.2
Recommended Dose and Dosage
Adjustment...................................................... 5
4.4
Administration.........................................................