APO-LACOSAMIDE TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

LACOSAMIDE

متاح من:

APOTEX INC

ATC رمز:

N03AX18

INN (الاسم الدولي):

LACOSAMIDE

جرعة:

50MG

الشكل الصيدلاني:

TABLET

تركيب:

LACOSAMIDE 50MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

30/100/1000

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

MISCELLANEOUS ANTICONVULSANTS

ملخص المنتج:

Active ingredient group (AIG) number: 0152810001; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2018-10-01

خصائص المنتج

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_APO-LACOSAMIDE (Lacosamide Tablets) _
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_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-LACOSAMIDE
Lacosamide Tablets
Tablets, 50 mg, 100 mg, 150 mg, and 200 mg, Oral
Antiepileptic
APOTEX INC.
Date of Initial Authorization:
150 Signet Drive
OCT 01, 2018
Toronto, Ontario
M9L 1T9
Date of Revision:
Submission Control Number: 271050
MAY 18, 2023
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_APO-LACOSAMIDE (Lacosamide Tablets) _
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_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
05/2023
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding
05/2023
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
...............................................................................................................
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
....................................................................................................
6
4.5
Missed Dos