SPEVIGO SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

SPESOLIMAB

Verfügbar ab:

BOEHRINGER INGELHEIM (CANADA) LTD LTEE

ATC-Code:

L04AC22

INN (Internationale Bezeichnung):

SPESOLIMAB

Dosierung:

60MG

Darreichungsform:

SOLUTION

Zusammensetzung:

SPESOLIMAB 60MG

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

15G/50G

Verschreibungstyp:

Prescription

Produktbesonderheiten:

Active ingredient group (AIG) number: 0164521001; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2023-03-22

Fachinformation

_Product Monograph _
_ _
_Spevigo (spesolimab) _
_Page 1 of 21_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SPEVIGO®
spesolimab for injection
Concentrate for solution for intravenous infusion
450 mg/7.5 mL (60 mg/mL)
Interleukin-36 Inhibitor
ATC code: L04AC22
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road
Burlington, Ontario
L7L 5H4
www.boehringer-ingelheim.ca
Date of Initial Authorization:
MAR 22, 2023
Submission Control Number: 267362
BICL #0174-01
Spevigo® is a registered trademark of Boehringer Ingelheim
International GmbH, used under
license.
_ _
_Product Monograph _
_ _
_Spevigo (spesolimab) _
_Page 2 of 21_
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics (<18 years of age)
....................................................................................
4
1.2
Geriatrics (≥65 years of age)
....................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
.............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 4
4.3
Reconstitution
..........................................................................................................
5
4.4
Administration
.......................................................................