RIXIMYO SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

RITUXIMAB

Boleh didapati daripada:

SANDOZ CANADA INCORPORATED

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:

2020-04-28

Ciri produk

_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