국가: 캐나다
언어: 영어
출처: Health Canada
LACOSAMIDE
APOTEX INC
N03AX18
LACOSAMIDE
200MG
TABLET
LACOSAMIDE 200MG
ORAL
30/60/100/1000
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0152810004; AHFS:
APPROVED
2018-10-01
_ _ _ _ _ _ _APO-LACOSAMIDE (Lacosamide Tablets) _ _ _ _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 _ _ _ _ _ _ _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 전체 문서 읽기