ACTEMRA SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

TOCILIZUMAB

Tilgjengelig fra:

HOFFMANN-LA ROCHE LIMITED

ATC-kode:

L04AC07

INN (International Name):

TOCILIZUMAB

Dosering :

200MG

Legemiddelform:

SOLUTION

Sammensetning:

TOCILIZUMAB 200MG

Administreringsrute:

INTRAVENOUS

Enheter i pakken:

4X10ML

Resept typen:

Prescription

Terapeutisk område:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2010-04-30

Preparatomtale

_ _
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
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RECENT MAJOR LABEL CHANGES
1 INDICATIONS
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4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
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4 DOSAGE AND ADMINISTRATION, 4.2
Recommended Dose and
Dosage Adjustment
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4 DOSAGE AND ADMINISTRATION, 4.4 Administration
11/2022
7 WARNINGS AND PRECAUTIONS
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TABLE OF CONTENTS
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TABLE OF CONTENTS
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PART I: HEALTH PROFESSIONAL INFORMATION
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INDICATIONS
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1.1
Pediatrics
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Geriatrics.............................................................................................................5
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CONTRAINDICATIONS
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SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND
ADMINISTRATION............................