ACTEMRA SOLUTION

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

TOCILIZUMAB

Disponibbli minn:

HOFFMANN-LA ROCHE LIMITED

Kodiċi ATC:

L04AC07

INN (Isem Internazzjonali):

TOCILIZUMAB

Dożaġġ:

162MG

Għamla farmaċewtika:

SOLUTION

Kompożizzjoni:

TOCILIZUMAB 162MG

Rotta amministrattiva:

SUBCUTANEOUS

Unitajiet fil-pakkett:

4 AUTOINJECTORS

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

DISEASE-MODIFYING ANTIRHEUMATIC AGENTS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0152713002; AHFS:

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2018-11-28

Karatteristiċi tal-prodott

_ _
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
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
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RECENT MAJOR LABEL
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TABLE OF CONTENTS
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PART I: HEALTH PROFESSIONAL INFORMATION
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1
INDICATIONS
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1.1
Pediatrics
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1.2
Geriatrics.............................................................................................................5
2
CONTRAINDICATIONS
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3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND
ADMINISTRATION............................