Ország: Kanada
Nyelv: angol
Forrás: Health Canada
LACOSAMIDE
ALEMBIC PHARMACEUTICALS LIMITED
N03AX18
LACOSAMIDE
100MG
TABLET
LACOSAMIDE 100MG
ORAL
60
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0152810002; AHFS:
APPROVED
2018-10-01
______________________________________________________________________________ _Alembic-Lacosamide Product Monograph_ _ Page 1 of 43_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR ALEMBIC-LACOSAMIDE Lacosamide Tablets Tablets; 50 mg, 100 mg, 150 mg and 200 mg, Oral Ph.Eur. Antiepileptic Agent ATC Code: N03AX18 Manufactured by: Date of Initial Authorization: Alembic Pharmaceuticals Limited December 19, 2018 Alembic Road, Vadodara – 390003, Gujarat, India Canadian Importer and Distributor: Date of Revision: Alembic Pharmaceuticals Canada Ltd. February 7, 2023 2680, Matheson Blvd. East, Unit 102 Mississauga, Ontario L4W 0A5, Canada Submission Control Number: 271051 ______________________________________________________________________________ _Alembic-Lacosamide Product Monograph_ _ Page 2 of 43_ RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions, 7.1.1 Pregnant Women 02/2023 7 Warnings and Precautions, 7.1.2 Breast-feeding 02/2023 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..................................................................... Olvassa el a teljes dokumentumot