ADDERALL XR CAPSULE (EXTENDED RELEASE)

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

MIXED SALTS AMPHETAMINE

Prieinama:

TAKEDA CANADA INC

ATC kodas:

N06BA01

INN (Tarptautinis Pavadinimas):

AMFETAMINE

Dozė:

20MG

Vaisto forma:

CAPSULE (EXTENDED RELEASE)

Sudėtis:

MIXED SALTS AMPHETAMINE 20MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

100

Recepto tipas:

Schedule G (CDSA I)

Gydymo sritis:

AMPHETAMINES

Produkto santrauka:

Active ingredient group (AIG) number: 0161310004; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2007-10-04

Prekės savybės

_ADDERALL XR_
_®_
_ (mixed salts amphetamine extended-release capsules) _
_Page 1 of 43 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ADDERALL XR®
mixed salts amphetamine
extended-release capsule
5 mg, 10 mg, 15 mg, 20 mg, 25 mg, 30 mg
Oral
Central Nervous System Stimulant
Takeda Canada Inc.
22 Adelaide Street West, Suite 3800
Toronto, Ontario
M5H 4E3
Date of Initial Authorization:
JAN 23, 2004
Date of Revision:
MAR 09, 2023
Submission Control Number: 269618
ADDERALL XR
_®_
and ADDERALL
_®_
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.
_ _
_ADDERALL XR_
_®_
_ (mixed salts amphetamine extended-release capsules) _
_Page 2 of 43_
RECENT MAJOR LABEL CHANGES
No major label changes during the past 24 months.
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
...................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.........................................................