Spinraza

Quốc gia: New Zealand

Ngôn ngữ: Tiếng Anh

Nguồn: Medsafe (Medicines Safety Authority)

Thành phần hoạt chất:

Nusinersen 12mg equivalent to equivalent to 12.6 mg nusinersen heptadecasodium

Sẵn có từ:

Biogen NZ Biopharma Ltd

Liều dùng:

12 mg/5mL

Dạng dược phẩm:

Solution for injection

Thành phần:

Active: Nusinersen 12mg equivalent to equivalent to 12.6 mg nusinersen heptadecasodium Excipient: Calcium chloride dihydrate Dibasic sodium phosphate Hydrochloric acid Magnesium chloride hexahydrate Monobasic sodium phosphate dihydrate Potassium chloride Sodium chloride Sodium hydroxide Water for injection

Loại thuốc theo toa:

Prescription

Chỉ dẫn điều trị:

SPINRAZA is indicated for the treatment of 5q Spinal Muscular Atrophy

Tóm tắt sản phẩm:

Package - Contents - Shelf Life: Vial, glass, Type I clear glass vial closed with Bromobutyl rubber stopper, Alu overseal and plastic cap - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 14 days unopened stored at or below 30°C protect from light 6 hours opened stored at or below 25°C

Ngày ủy quyền:

2018-01-08

Tờ rơi thông tin

SPINRAZA
1
SPINRAZA®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are
worried for you or your child
about using this medicine, speak to your
doctor, nurse or pharmacist.
1.
WHY AM I USING SPINRAZA?
SPINRAZA has nusinersen (as heptadecasodium) as active ingredient.
SPINRAZA is used to treat the genetic disease called Spinal
Muscular Atrophy (SMA).
For more information, see Section 1. Why am I using SPINRAZA? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE SPINRAZA?
Do not use if you have ever had an allergic reaction to SPINRAZA or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR OR NURSE IF YOU OR YOUR CHILD HAVE ANY OTHER
MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT
OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
SPINRAZA? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with SPINRAZA and affect how it works.
Additional information is found in Section 3. What if I am taking
other medicines? in the full CMI.
4.
HOW DO I USE SPINRAZA?
•
The usual dose of SPINRAZA is 12 mg administered by an experienced
doctor, and given as a continuous injection (over 1 to 3
minutes) into the lower back by lumbar puncture.
•
Your doctor may give you or your child a medicine to make you or your
child relax or sleep (sedation) before giving
SPINRAZA.
More instructions can be found in Section 4. How do I use SPINRAZA? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING SPINRAZA?
THINGS YOU
SHOULD DO
•
Keep all of your or your child's hospital, doctor and physiotherapy
appointments so that you or your
child's progress can be checked.
•
Remind any doctor, dentist, nurse or pharmacist you or your child
visit that you are receiving
SPINRAZA.
THINGS YOU
SHOULD NOT DO
•
Do not stop receiving this medicine without consulting your doctor.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until

Đặc tính sản phẩm

Spinraza Data Sheet November 2023
Page 1 of 27
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
SPINRAZA nusinersen solution for injection 12 mg/5 mL.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single-use vial contains 12.6 mg of nusinersen heptadecasodium
equivalent to 12 mg of
nusinersen as the free acid (or 2.4 mg/mL) in artificial cerebrospinal
fluid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Sterile, preservative-free, clear to colourless isotonic solution,
practically free from visible
particles, with pH of approximately 7.2.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
SPINRAZA is indicated for the treatment of 5q Spinal Muscular Atrophy
(SMA).
4.2
DOSE AND METHOD OF ADMINISTRATION
Treatment should be initiated and supervised by specialist medical
practitioners experienced
in the diagnosis and management of SMA.
Dose
The recommended dosage is 12 mg (5 mL) per administration. Initiate
SPINRAZA treatment
as early as possible after diagnosis with 4 loading doses on Days 0,
14, 28, and 63. A
maintenance dose should be administered once every 4 months
thereafter. (See _ Special _
_dosage instructions for intrathecal administration_).
Dose delay
If a loading or a maintenance dose is delayed or missed SPINRAZA
should be administered
according to the schedule in Table 1 below.
TABLE 1: DOSING ADMINISTRATION OF DELAYED OR MISSED DOSE
DELAYED OR MISSED DOSE
TIMING OF DOSING ADMINISTRATION
LOADING DOSE
•
Administer the delayed or missed loading dose as soon as possible with
at least 14
days between doses; continue with subsequent doses on the prescribed
intervals from
the last dose.
e.g. if the third loading dose is administered 30 days late at Day 58
(instead of the original
schedule at Day 28), then the fourth loading dose should be
administered 35 days later at
Spinraza Data Sheet November 2023
Page 2 of 27
Day 93 (instead of the original schedule at Day 63) with a maintenance
dose 4 months
thereafter.
MAINTENANCE DOSE
TIMING OF DOSING ADMINISTRATION
>4 t