TRUXIMA SOLUTION

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

RITUXIMAB

から入手可能:

CELLTRION HEALTHCARE CO LTD

ATCコード:

L01FA01

INN（国際名）:

RITUXIMAB

投薬量:

100MG

医薬品形態:

SOLUTION

構図:

RITUXIMAB 100MG

投与経路:

INTRAVENOUS

パッケージ内のユニット:

10 ML

処方タイプ:

Prescription

治療領域:

ANTINEOPLASTIC AGENTS

製品概要:

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

認証ステータス:

APPROVED

承認日:

2019-04-04

製品の特徴

_ _
_Page 1 of 128_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRUXIMA
TM
Rituximab for Injection
10 mg/mL Intravenous Infusion
Professed Standard
Antineoplastic
Manufactured by:
Celltrion Healthcare Co. Ltd.
19, Academy-ro 51 beon-gil,
Yeonsu-gu, Incheon
Republic of Korea
22014
Distributed by:
Teva Canada Limited.
Toronto, Ontario M1B 2K9
Date of Initial Approval:
Apr 04, 2019
Date of Revision:
May 22, 2020
Submission Control No: 228130
Pr
Truxima
TM
is a trademark of Celltrion Healthcare Co., Ltd.
_ _
_Page 2 of 128_
RECENT MAJOR LABEL CHANGES
The following sections have been updated to include the information of
GPA/MPA indications (Apr 2020).
1
INDICATIONS
3
SERIOUS WARNINGS AND PRECAUTIONS
4.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
4.3
ADMINISTRATION
8
WARNINGS AND PRECAUTIONS
9
ADVERSE DRUG REACTIONS
11.3
PHARMACOKINETICS
17
CLINICAL TRIALS – REFERENCE BIOLOGIC DRUG
PATIENT MEDICATION INFORMATION
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
.......................................................................
6
4
DOSAGE AND ADMINISTRATION
..........................................................................................
7
4.1
DOSING CONSIDERATIONS
.....................................................................................................
7
4.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
.......