ULTOMIRIS SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

RAVULIZUMAB

Dostupné z:

ALEXION PHARMA GMBH

ATC kód:

L04AJ02

INN (Medzinárodný Name):

RAVULIZUMAB

Dávkovanie:

1100MG

Forma lieku:

SOLUTION

Zloženie:

RAVULIZUMAB 1100MG

Spôsob podávania:

INTRAVENOUS

Počet v balení:

15G/50G

Typ predpisu:

Prescription

Prehľad produktov:

Active ingredient group (AIG) number: 0161710002; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2022-12-13

Súhrn charakteristických

ULTOMIRIS
®
(ravulizumab) Product Monograph
Page 1 of 58
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ULTOMIRIS
®
RAVULIZUMAB FOR INJECTION
10 mg/mL & 100 mg/mL
concentrate for solution for intravenous infusion
Selective immunosuppressant
Submission Control Number: 269852
Alexion Pharma GmbH
Neuhofstrasse 34
Baar, Switzerland
6340
Imported by:
Alexion Pharma Canada Corp.
1004 Middlegate Road, Suite #5000
Mississauga, ON L4Y 1M4
Date of Initial Authorization:
AUG 28, 2019
Date of Revision:
OCT 30, 2023
ULTOMIRIS
®
(ravulizumab) Product Monograph
Page 2 of 58
RECENT MAJOR LABEL CHANGES
[1 Indications]
[12/2022]
[4 Dosage & Administration], [4.2 Recommended Dose & Dosage
Adjustment] [12/ 2022]
[7 Warnings & Precautions]
[11/2022]
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
................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
.................................................................