SPINRAZA SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

NUSINERSEN (NUSINERSEN SODIUM)

Tersedia dari:

BIOGEN CANADA INC

Kode ATC:

M09AX07

INN (Nama Internasional):

NUSINERSEN

Dosis:

2.4MG

Bentuk farmasi:

SOLUTION

Komposisi:

NUSINERSEN (NUSINERSEN SODIUM) 2.4MG

Rute administrasi :

INTRATHECAL

Unit dalam paket:

5ML

Jenis Resep:

Prescription

Area terapi:

ANTISENSE OLIGONUCLEOTIDES

Ringkasan produk:

Active ingredient group (AIG) number: 0159230001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2017-06-29

Karakteristik produk

_SPINRAZA (nusinersen injection) _
_Page 1 of 46_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
SPINRAZA
TM
(nusinersen injection)
solution for injection, 2.4 mg/mL nusinersen (as nusinersen sodium),
intrathecal
Other drugs for disorders of the musculo-skeletal system
Biogen Canada Inc.
3250 Bloor Street West, East Tower, Suite 1200
Toronto, Ontario M8X 2X9
Date of Initial Authorization:
June 29, 2017
Date of Revision:
MAR 5, 2024
Submission Control Number: 281187
_ _
_SPINRAZA (nusinersen injection) _
_Page 2 of 46_
RECENT MAJOR LABEL CHANGES
4 DOSAGE AND ADMINISTRATION, 4.5 Missed Dose
05/2023
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
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.4
Administration
...........................................................................................