RUXIENCE SOLUTION

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

RITUXIMAB

Boleh didapati daripada:

PFIZER CANADA ULC

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:

2020-05-04

Ciri produk

_RUXIENCE (rituximab for injection) _
_Page 1 of 126_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RUXIENCE®
rituximab for injection
10 mg/mL Intravenous Infusion
Professed Standard
Antineoplastic
ATC Code: L01FA01
Pfizer Canada ULC
17,300 Trans Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Initial Authorization:
MAY 04, 2020
Date of Revision:
MAR 06, 2024
Submission Control Number: 279813
®
Pfizer Inc.
Pfizer Canada ULC, Licensee
_RUXIENCE (rituximab for injection) _
_Page 2 of 126_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, 7.1.2 Breast-feeding
02/2024
TABLE OF CONTENTS
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
Recommended Dose and Dosage Adjustment
........................................................ 7
4.3
Reconstitution
................................................................................................