Spinraza 12mg5ml solution for injection vials

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: MHRA (Medicines & Healthcare Products Regulatory Agency)

সক্রিয় উপাদান:

Nusinersen sodium

থেকে পাওয়া:

Biogen Idec Ltd

এটিসি কোড:

M09AX07

INN (আন্তর্জাতিক নাম):

Nusinersen sodium

ডোজ:

2.4mg/1ml

ফার্মাসিউটিকাল ফর্ম:

Solution for injection

প্রশাসন রুট:

Intrathecal

শ্রেণী:

No Controlled Drug Status

প্রেসক্রিপশন টাইপ:

Valid as a prescribable product

পণ্য সারাংশ:

BNF: ; GTIN: 5713219500777

তথ্য লিফলেট

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SPINRAZA 12 MG SOLUTION FOR INJECTION
nusinersen
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD RECEIVES
THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or nurse.

If you or your child gets any side effects, talk to your doctor or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Spinraza is and what it is used for
2.
What you need to know before you or your child are given Spinraza
3.
How Spinraza is given
4.
Possible side effects
5.
How to store Spinraza
6.
Contents of the pack and other information
1.
WHAT SPINRAZA IS AND WHAT IT IS USED FOR
Spinraza contains the active substance
_nusinersen_
which belongs to a group of medicines known as
_antisense oligonucleotides_
. Spinraza is used to treat a genetic disease called
_spinal muscular atrophy_
(SMA).
SPINAL MUSCULAR ATROPHY
is caused by a shortage of a protein called
_survival motor neuron_
(SMN) in
the body. This results in the loss of nerve cells in the spine,
leading to weakness of the muscles in the
shoulders, hips, thighs and upper back. It may also weaken the muscles
used for breathing and
swallowing.
Spinraza works by helping the body to produce more of the SMN protein
that people with SMA are
lacking. This reduces the loss of nerve cells and so may improve
muscle strength.
2.
WHAT YOU NEED TO KNOW BEFORE YOU OR YOUR CHILD ARE GIVEN SPINRAZA
_ _
SPINRAZA MUST NOT BE GIVEN:

If you or your child are
ALLERGIC TO NUSINERSEN
or any of the other ingredients of this medicine
(listed in section 6).
If you are not sure, talk to your doctor or nurse before you or your
child are giv

পণ্য বৈশিষ্ট্য

OBJECT 1
SPINRAZA 12 MG SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 16-Nov-2017 | Biogen Idec
Ltd
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Spinraza 12 mg solution for injection
2. Qualitative and quantitative composition
Each 5 ml vial contains nusinersen sodium equivalent to 12 mg
nusinersen.
Each ml contains 2.4 mg of nusinersen.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
Clear and colourless solution with pH of approximately 7.2.
4. Clinical particulars
4.1 Therapeutic indications
Spinraza is indicated for the treatment of 5q Spinal Muscular Atrophy.
4.2 Posology and method of administration
Treatment with Spinraza should only be initiated by a physician with
experience in the management of
spinal muscular atrophy (SMA).
The decision to treat should be based on an individualised expert
evaluation of the expected benefits of
treatment for that individual, balanced against the potential risk of
treatment with Spinraza. Patients with
profound hypotonia and respiratory failure at birth, where Spinraza
has not been studied, may not
experience a clinically meaningful benefit due to severe SMN protein
deficiency.
Posology
The recommended dosage is 12 mg (5 ml) per administration.
Spinraza treatment should be initiated 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.
_Duration of treatment_
Information on long term efficacy of this medicinal product is not
available. The need for continuation of
therapy should be reviewed regularly and considered on an individual
basis depending on the patient's
clinical presentation and response to the therapy.
_Missed or delayed doses_
If a loading dose is de