Country: Canada
Language: English
Source: Health Canada
ECULIZUMAB
ALEXION PHARMA GMBH
L04AJ01
ECULIZUMAB
10MG
SOLUTION
ECULIZUMAB 10MG
INTRAVENOUS
30ML
Prescription
COMPLEMENT INHIBITORS
Active ingredient group (AIG) number: 0152512001; AHFS:
APPROVED
2013-04-19
_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 Read the complete document