PHARMA-LACOSAMIDE TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

LACOSAMIDE

متاح من:

PHARMASCIENCE INC

ATC رمز:

N03AX18

INN (الاسم الدولي):

LACOSAMIDE

جرعة:

150MG

الشكل الصيدلاني:

TABLET

تركيب:

LACOSAMIDE 150MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

60

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

MISCELLANEOUS ANTICONVULSANTS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2018-10-01

خصائص المنتج

______________________________________________________________________________
_pharma-LACOSAMIDE Product Monograph_
_ Page 1 of 44_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PHARMA-LACOSAMIDE
Lacosamide Tablets
Tablets; 50 mg, 100 mg, 150 mg and 200 mg, Oral
Ph.Eur.
Antiepileptic Agent
ATC Code: N03AX18
PHARMASCIENCE INC.:
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Submission Control Number: 273596
Date of Initial
Authorization:
OCT
1, 2018
Date of Revision:
APR
14, 2023
______________________________________________________________________________
_pharma-LACOSAMIDE Product Monograph_
_ Page 2 of 44_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.1 Pregnant Women
04/2023
7 Warnings and Precautions, 7.1.2 Breast-feeding
04/2023
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
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