AZILECT TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

RASAGILINE (RASAGILINE MESYLATE)

Dostupné z:

TEVA CANADA LIMITED

ATC kód:

N04BD02

INN (Medzinárodný Name):

RASAGILINE

Dávkovanie:

0.5MG

Forma lieku:

TABLET

Zloženie:

RASAGILINE (RASAGILINE MESYLATE) 0.5MG

Spôsob podávania:

ORAL

Počet v balení:

30

Typ predpisu:

Prescription

Terapeutické oblasti:

MONOAMINE OXIDASE B INHIBITORS

Prehľad produktov:

Active ingredient group (AIG) number: 0151662001; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2021-06-03

Súhrn charakteristických

_AZILECT (rasagiline) _
_Page 1 of 48 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
AZILECT
®
Rasagiline Tablets
Tablet, 0.5 mg and 1 mg (as rasagiline mesylate), Oral
Professed Standard
Antiparkinson Agent
Teva Canada Limited
Toronto, Ontario, M1B 2K9
Manufactured for:
Teva Canada Innovation
Montreal, Quebec H2Z 1S8
Date of Initial Authorization:
August 17, 2006
Date of Revision:
February 10, 2022
Submission Control Number: 255783
_ _
_AZILECT (rasagiline) _
_Page 2 of 48 _
RECENT MAJOR LABEL CHANGES
2 Contraindications
02/2022
7 Warnings and Precautions
02/2022
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...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
6
4.1
Dosing Considerations
.......................................................................................
6
4.2
Recommended Dose and Dosage
Adjustment..................................................... 6
4.4
Administration............................................