RIABNI SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

RITUXIMAB

Boleh didapati daripada:

AMGEN CANADA INC

Kod ATC:

L01FA01

INN (Nama Antarabangsa):

RITUXIMAB

Dos:

10MG

Borang farmaseutikal:

SOLUTION

Komposisi:

RITUXIMAB 10MG

Laluan pentadbiran:

INTRAVENOUS

Unit dalam pakej:

15G/50G

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2021-03-11

Ciri produk

_RIABNI (rituximab) _
_Page 1 of 128_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RIABNI™
rituximab for injection
10 mg/mL Intravenous Infusion
Professed Standard
Antineoplastic
Amgen Canada Inc.
6775 Financial Drive, Suite 100
Mississauga, ON L5N 0A4
Date of Initial Authorization:
March 11, 2021
Submission Control Number: 237814

2021 Amgen Canada Inc., All Rights Reserved.
_RIABNI (rituximab) _
_Page 2 of 128_
RECENT MAJOR LABEL CHANGES
N/A
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
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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
................................................................................
7
4.1
Dosing Considerations
..........................................................................................
7
4.2
Recommended Dose and Dosage Adjustment
...................................................... 7
4.3
Reconstitution
.......................................................................................................
9
4.4
Administration
.....................................................................................................
10
4.5
Missed Dose
.......................................................................................................
11
5
OVERDOSAGE
...................