Страна: Канада
мова: англійська
Джерело: Health Canada
LISDEXAMFETAMINE DIMESYLATE
TAKEDA CANADA INC
N06BA12
LISDEXAMFETAMINE
50MG
CAPSULE
LISDEXAMFETAMINE DIMESYLATE 50MG
ORAL
100
Schedule G (CDSA I)
AMPHETAMINES
Active ingredient group (AIG) number: 0152536002; AHFS:
APPROVED
2015-02-12
_VYVANSE_ _®_ _ (lisdexamfetamine dimesylate) _ _Page 1 of 67_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION VYVANSE® lisdexamfetamine dimesylate capsules Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg, oral lisdexamfetamine dimesylate chewable tablets Chewable Tablets, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg, oral Central Nervous System Stimulant Takeda Canada Inc. 22 Adelaide Street West, Suite 3800 Toronto, Ontario M5H 4E3 Date of Initial Authorization: 19 February 2009 Date of Revision: MAR 20, 2024 Submission Control Number: 280611 VYVANSE® and the VYVANSE Logo® are registered trademarks of Takeda Pharmaceuticals U.S.A., Inc. TAKEDA® and the TAKEDA Logo® are registered trademarks of Takeda Pharmaceutical Company Limited, used under license. _VYVANSE_ _®_ _ (lisdexamfetamine dimesylate) _ _Page 2 of 67_ RECENT MAJOR LABEL CHANGES 7 WARNINGS AND PRECAUTIONS, Cardiovascular, QTc Prolongation 03/2024 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 ................................................................................................................. 5 1.2 Geriatrics ................................................................................................................. 6 2 CONTRAINDICATIONS ................................................................................................... 6 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .............................................................. Прочитайте повний документ