Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
LACOSAMIDE
JAMP PHARMA CORPORATION
N03AX18
LACOSAMIDE
150MG
TABLET
LACOSAMIDE 150MG
ORAL
15G/50G
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0152810003; AHFS:
APPROVED
2019-05-10
_JAMP-Lacosamide Product Monograph _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 1 of 47 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR JAMP-LACOSAMIDE Lacosamide Tablets Tablets, 50 mg, 100 mg, 150 mg, 200 mg, Oral Antiepileptic ATC Code: N03AX18 JAMP Pharma Corporation 1310 rue Nobel Boucherville, Quebec. J4B 5H3,Canada Date of Initial Authorization: May 8, 2019 Date of Revision: December 8, 2022 Submission Control Number: 265635 _JAMP-Lacosamide Product Monograph _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _Page 2 of 47 _ RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions, 7.1.1 Pregnant Women 12/2022 7 Warnings and Precautions, 7.1.2 Breast-feeding 12/2022 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...................................................... 5 4.4 Administration......................................................... Aqra d-dokument sħiħ