RITUXAN SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

RITUXIMAB

Доступна з:

HOFFMANN-LA ROCHE LIMITED

Код атс:

L01FA01

ІПН (Міжнародна Ім'я):

RITUXIMAB

Дозування:

10MG

Фармацевтична форма:

SOLUTION

Склад:

RITUXIMAB 10MG

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

10/50 ML

Тип рецепту:

Prescription

Терапевтична области:

ANTINEOPLASTIC AGENTS

Огляд продуктів:

Active ingredient group (AIG) number: 0140241001; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2000-03-17

Характеристики продукта

_ _
_Pr_
_RITUXAN_
_®_
_ (rituximab for injection) _
_Page 1 of 123 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RITUXAN®
rituximab for injection
10 mg/mL Intravenous Infusion
Professed Standard
Antineoplastic
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario
L5N 5M8
www.rochecanada.com
Date of Initial Authorization:
March 17, 2000
Date of Revision:
June 2, 2023
Submission Control Number: 271112
®Registered trade-mark of IDEC Pharmaceuticals Corporation, used
under license
©
Copyright 2000-2023, Hoffmann-La Roche Limited
_ _
_Pr_
_RITUXAN_
_®_
_ (rituximab for injection) _
_Page 2 of 123 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.2 Breast-feeding
05/2023
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
................................................................................................................
5
1.2
Geriatrics
................................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
6
4.1
Dosing Considerations
............................................................................................
6
4.2