ALECENSARO CAPSULE

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

ALECTINIB (ALECTINIB HYDROCHLORIDE)

Доступна з:

HOFFMANN-LA ROCHE LIMITED

Код атс:

L01ED03

ІПН (Міжнародна Ім'я):

ALECTINIB

Дозування:

150MG

Фармацевтична форма:

CAPSULE

Склад:

ALECTINIB (ALECTINIB HYDROCHLORIDE) 150MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

240

Тип рецепту:

Prescription

Терапевтична области:

ANTINEOPLASTIC AGENTS

Огляд продуктів:

Active ingredient group (AIG) number: 0158510001; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2016-09-29

Характеристики продукта

_ALECENSARO_
_®_
_ (alectinib) _
_ _
_ _
_Page 1 of 44_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ALECENSARO®
alectinib (as alectinib hydrochloride)
Capsule, 150 mg
Protein Kinase Inhibitor (ATC Code: L01E)
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario, Canada
L5N 5M8
www.rochecanada.com
Date of Initial Authorization:
September 29, 2016
Date of Revision:
May 09, 2022
Submission Control Number: 260345
_ _
_ALECENSARO_
_®_
_ (alectinib) _
_Page 2 of 44_
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration, 4.2 Recommended Dose and
Dosage Adjustment
05/2022
7 Warnings and Precautions
05/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
..............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics (< 18 years of
age)..............................................................................
4
1.2
Geriatrics (≥ 65 years of age)
..............................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment..................................................... 5
4.3
Reconstitution
...................................................................................................
7
4.4
Administration...