Страна: Канада
мова: англійська
Джерело: Health Canada
SOLRIAMFETOL (SOLRIAMFETOL HYDROCHLORIDE)
AXSOME MALTA LTD.
N06BA14
SOLRIAMFETOL
75MG
TABLET
SOLRIAMFETOL (SOLRIAMFETOL HYDROCHLORIDE) 75MG
ORAL
15G/50G
Prescription
Wakefulness-Promoting Agents
Active ingredient group (AIG) number: 0162888001; AHFS:
APPROVED
2021-05-13
_ _ _ _ _Page 1 of 38_ _SUNOSI (solriamfetol)_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION Pr SUNOSI® solriamfetol tablets Film-coated Tablet, 75 mg and 150 mg solriamfetol (as solriamfetol hydrochloride), Oral Psychoanaleptic Date of Initial Authorization: August 24, 2022 Axsome Malta Ltd. 93 Mill Street, Zone 5, Central Business District Qormi CBD 5090, Malta Imported by: Innomar Strategies Inc. 3470 Superior Crt. Oakville, Ontario L6L 0C4 Submission Control Number: 266452 SUNOSI® is a registered trademark of Axsome Malta Ltd. or its affiliates ©2021 Axsome Malta Ltd. All rights reserved. _ _ _SUNOSI (solriamfetol) _ _Page 2 of 38 _ TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF AUTHORIZATION ARE NOT LISTED. 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 ................................................................................ 5 4.1 Dosing Considerations ............................................................................................. 5 4.2 Recommended Dose and Dosage Adjustment ........................................................ 5 4.3 Administration ......................................................................................................... 6 4.4 Missed Dose ........................................... Прочитайте повний документ