ALERTEC TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

MODAFINIL

Tilgængelig fra:

TEVA CANADA LIMITED

ATC-kode:

N06BA07

INN (International Name):

MODAFINIL

Dosering:

100MG

Lægemiddelform:

TABLET

Sammensætning:

MODAFINIL 100MG

Indgivelsesvej:

ORAL

Enheder i pakken:

30

Recept type:

Prescription

Terapeutisk område:

Wakefulness-Promoting Agents

Produkt oversigt:

Active ingredient group (AIG) number: 0136083001; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2012-01-03

Produktets egenskaber

_ _
_Product Monograph _
_ _
_ALERTEC modafinil _
_Page 1 of 45 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ALERTEC
®*
modafinil
Tablets, 100 mg, Oral
Mfr. Std.
Central Nervous System Stimulant
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
Marketed by:
Teva Canada Innovation
Montréal, Quebec
H2Z 1S8
Date of Initial Authorization:
February 26, 1999
Date of Revision:
July 4, 2023
Submission Control Number: 272079
*
ALERTEC is a registered trademark of Cephalon, Inc. Used under license
by Teva Canada Innovation.
_ _
_Product Monograph _
_ _
_ALERTEC modafinil _
_Page 2 of 45 _
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration
11/2021
7 Warnings and Precautions, Alcohol Consumption, Risk of
stroke
11/2021
7 Warnings and Precautions, Dependence/Tolerance
07/2023
9 Drug-Behavioural Interactions – Alcohol Consumption
07/2023
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
.............................................................................................................
5
2
CONTRAINDICATIONS
................................................................................................
5
4
DOSAGE AND ADMINISTRATION
..............................................................................
5
4.1
Dosing Considerations
...................................................................