SOLIRIS SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ECULIZUMAB

Available from:

ALEXION PHARMA GMBH

ATC code:

L04AJ01

INN (International Name):

ECULIZUMAB

Dosage:

10MG

Pharmaceutical form:

SOLUTION

Composition:

ECULIZUMAB 10MG

Administration route:

INTRAVENOUS

Units in package:

30ML

Prescription type:

Prescription

Therapeutic area:

COMPLEMENT INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0152512001; AHFS:

Authorization status:

APPROVED

Authorization date:

2013-04-19

Summary of Product characteristics

_Alexion Product Monograph – SOLIRIS_
_®_
_ _
_Page 1 of 61_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SOLIRIS
®
(eculizumab for injection)
30 mL Parenteral Solution (10 mg/mL)
(Humanized Monoclonal Antibody)
Alexion Pharma GmbH
Date of Initial Approval: January 28, 2009
Giesshübelstrasse 30
CH-8045 Zürich, Switzerland
Control No: 245907
Date of Revision: March 25, 2021
_Alexion Product Monograph – SOLIRIS_
_®_
_ _
_Page 2 of 61_
RECENT MAJOR LABEL CHANGES
Indications, Generalized Myasthenia Gravis, Section 1, AUG 2018
Indications, Neuromyelitis Optica Spectrum Disorder, Section 1, SEPT
2019
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 ................................................ 6
4
DOSAGE AND ADMINISTRATION ...........................................................................
7
4.1
Dosing Considerations
...........................................................................................
7
4.2
Recommended Dose and Dosage Adjustment
........................................................ 7
4.3
Administration
.......................................................................................................
9
4.4
Reconstituti