ACTEMRA SOLUTION

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

TOCILIZUMAB

Disponible desde:

HOFFMANN-LA ROCHE LIMITED

Código ATC:

L04AC07

Designación común internacional (DCI):

TOCILIZUMAB

Dosis:

400MG

formulario farmacéutico:

SOLUTION

Composición:

TOCILIZUMAB 400MG

Vía de administración:

INTRAVENOUS

Unidades en paquete:

4X20ML

tipo de receta:

Prescription

Área terapéutica:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0152713001; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2010-04-30

Ficha técnica

_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ACTEMRA®
tocilizumab
tocilizumab for injection (20 mg/mL) vials
tocilizumab injection (162 mg/ 0.9 mL) pre-filled syringe and
Autoinjector
Professed Standard
Interleukin Inhibitor
Hoffmann-La Roche Limited
7070 Mississauga Road
Mississauga, Ontario, Canada
L5N 5M8
www.rochecanada.com
Date of Initial Authorization:
April 30, 2010
Date of Revision:
November 28, 2022
Submission Control Number: 268502
ACTEMRA® is a registered trade-mark of Chugai Seiyaku Kabushiki
Kaisha used under license.
©Copyright 2010-2022 Hoffmann-La Roche Limited
_ _
_Page 2 of 153 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
10/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
10/2022
4 DOSAGE AND ADMINISTRATION, 4.2
Recommended Dose and
Dosage Adjustment
10/2022
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
11/2022
7 WARNINGS AND PRECAUTIONS
10/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL
CHANGES..............................................................................................2
TABLE OF CONTENTS
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics
............................................................................................................4
1.2
Geriatrics.............................................................................................................5
2
CONTRAINDICATIONS
...................................................................................................5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..............................................................5
4
DOSAGE AND
ADMINISTRATION............................