RIXIMYO SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

RITUXIMAB

Доступна з:

SANDOZ CANADA INCORPORATED

Код атс:

L01FA01

ІПН (Міжнародна Ім'я):

RITUXIMAB

Дозування:

10MG

Фармацевтична форма:

SOLUTION

Склад:

RITUXIMAB 10MG

Адміністрація маршрут:

INTRAVENOUS

Одиниць в упаковці:

15G/50G

Тип рецепту:

Prescription

Терапевтична области:

ANTINEOPLASTIC AGENTS

Огляд продуктів:

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

Статус Авторизація:

APPROVED

Дата Авторизація:

2020-04-28

Характеристики продукта

_RIXIMYO (rituximab for injection) Product Monograph _
_ _
_Page 1 of 122_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RIXIMYO
®
rituximab for injection
10 mg/mL Intravenous Infusion
Professed Standard
Antineoplastic
Sandoz Canada Inc.
Date of Initial Approval:
110, rue de Lauzon
April 28, 2020
Boucherville, Québec
J4B 1E6
Date of Revision:
March 4, 2022
Submission Control No: 259381
_ _
_RIXIMYO (rituximab for injection) Product Monograph _
_Page 2 of 122_
TABLE OF CONTENTS
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
Recommended Dose and Dosage Adjustment
.................................................... 7
4.3
Administration...................................................................................................
10
4.4
Dilution
.............................................................................................................
11
4.5
Missed
Dose.....................................................................................................
11
5
OVERDOSAGE
.........................................................................................................
11
6
DOSAGE FORMS, STRENGTHS, COMPOSITION A