OXLUMO SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

LUMASIRAN (LUMASIRAN SODIUM)

Dostopno od:

ALNYLAM NETHERLANDS B.V.

Koda artikla:

A16AX18

INN (mednarodno ime):

LUMASIRAN

Odmerek:

94.5MG

Farmacevtska oblika:

SOLUTION

Sestava:

LUMASIRAN (LUMASIRAN SODIUM) 94.5MG

Pot uporabe:

SUBCUTANEOUS

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Povzetek izdelek:

Active ingredient group (AIG) number: 0163440001; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2022-03-07

Lastnosti izdelka

_OXLUMO_
_®_
_(lumasiran injection) _
_Page 1 of 27 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
OXLUMO®
Lumasiran Injection
Solution, 94.5 mg/0.5 mL lumasiran (as lumasiran sodium), subcutaneous
injection
Various alimentary tract and metabolism products
Alnylam Netherlands B.V.
Antonio Vivaldistraat 150
1083 HP Amsterdam
Netherlands
Imported / Distributed by:
Innomar Strategies Inc.
Oakville, ON
L6L 0C4
Date of Initial Authorization:
MAR 03, 2022
Date of Revision:
DEC 01, 2023
Submission Control Number: 277966
_ _
_OXLUMO_
_®_
_(lumasiran injection) _
_Page 2 of 27_
RECENT MAJOR LABEL CHANGES
1.
INDICATIONS
05/2023
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
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
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
............................................................