VYVANSE TABLET (CHEWABLE)

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

LISDEXAMFETAMINE DIMESYLATE

Boleh didapati daripada:

TAKEDA CANADA INC

Kod ATC:

N06BA12

INN (Nama Antarabangsa):

LISDEXAMFETAMINE

Dos:

10MG

Borang farmaseutikal:

TABLET (CHEWABLE)

Komposisi:

LISDEXAMFETAMINE DIMESYLATE 10MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

15G/50G

Jenis preskripsi:

Schedule G (CDSA I)

Kawasan terapeutik:

AMPHETAMINES

Ringkasan produk:

Active ingredient group (AIG) number: 0152536006; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2019-07-08

Ciri produk

_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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics
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5
1.2
Geriatrics
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6
2
CONTRAINDICATIONS
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6
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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