APO-LACOSAMIDE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

LACOSAMIDE

Pieejams no:

APOTEX INC

ATĶ kods:

N03AX18

SNN (starptautisko nepatentēto nosaukumu):

LACOSAMIDE

Deva:

200MG

Zāļu forma:

TABLET

Kompozīcija:

LACOSAMIDE 200MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

30/60/100/1000

Receptes veids:

Prescription

Ārstniecības joma:

MISCELLANEOUS ANTICONVULSANTS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2018-10-01

Produkta apraksts

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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) _
_ _
_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