SPINRAZA SOLUTION

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

NUSINERSEN (NUSINERSEN SODIUM)

Fáanlegur frá:

BIOGEN CANADA INC

ATC númer:

M09AX07

INN (Alþjóðlegt nafn):

NUSINERSEN

Skammtar:

2.4MG

Lyfjaform:

SOLUTION

Samsetning:

NUSINERSEN (NUSINERSEN SODIUM) 2.4MG

Stjórnsýsluleið:

INTRATHECAL

Einingar í pakka:

5ML

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ANTISENSE OLIGONUCLEOTIDES

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2017-06-29

Vara einkenni

_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
...........................................................................................