AG-LACOSAMIDE TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

LACOSAMIDE

זמין מ:

ANGITA PHARMA INC.

קוד ATC:

N03AX18

INN (שם בינלאומי):

LACOSAMIDE

כמות:

200MG

טופס פרצבטיות:

TABLET

הרכב:

LACOSAMIDE 200MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

MISCELLANEOUS ANTICONVULSANTS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2020-07-13

מאפייני מוצר

_AG-Lacosamide Product Monograph _
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_Page 1 of 50 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-LACOSAMIDE
Lacosamide Tablets
Tablets, 50 mg, 100 mg, 150 mg, 200 mg, Oral
Antiepileptic
ATC Code: N03AX18
Angita Pharma Inc.
1310, rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
JUL 13, 2020
Date of Revision:
JUL 11, 2023
Submission Control Number: 276255
_AG-Lacosamide Product Monograph _
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_Page 2 of 50 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.1 Pregnant Women
07/2023
7 Warnings and Precautions, 7.1.2 Breast-feeding
07/2023
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
....................................................................................................................4
1.2
Geriatrics
....................................................................................................................4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.1
Dosing Considerations
................................................................................................4
4.2
Recommended Dose and Dosage Adjustment
...........................................................5
4.4
Administration
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