Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - spinraza

Document Subject

Generated Narrative: MedicinalProductDefinition mp7480c406c1476ad2011cc90003d94188

identifier: http://ema.europa.eu/identifier/EU/1/17/1188/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Spinraza 12 mg solution for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-7480c406c1476ad2011cc90003d94188

identifier: http://ema.europa.eu/identifier/EU/1/17/1188/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - spinraza

Attesters

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

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.

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 given Spinraza.

Warnings and precautions There is a risk of side effects occuring after Spinraza is given by a lumbar puncture procedure (see section 3). This can include headaches, vomiting and back pain. There may also be difficulties with giving a medicine by this method in very young patients and those with scoliosis (twisted and curved spine).

Other products that are in the same group of medicines as Spinraza have been shown to affect the cells in the blood which help clotting. Before you or your child are given Spinraza your doctor may decide to do a blood test to check that your or your child s blood can clot properly. This may not be required every time you or your child are given Spinraza. Other products that are in the same group of medicines as Spinraza have been shown to affect the kidneys. Before you or your child are given Spinraza your doctor may decide to do a urine test to check that your or your child s kidneys are working normally. This may not be required every time you or your child are given Spinraza.

There have been a small number of reports of patients developing hydrocephalus (a build-up of too much fluid around the brain) after Spinraza is given. Some of these patients had needed to have a device called a ventriculo-peritoneal shunt implanted to treat the hydrocephalus. If you notice any symptoms of increase in head size, decreased consciousness, persistent nausea, vomiting or headache; or other symptoms that cause you concern, please inform your or your child s doctor to seek necessary treatment. The benefits and risks of continuing Spinraza whilst having a "ventriculo-peritoneal shunt" in place are not known at present.

Talk to your doctor before you or your child are given Spinraza.

Other medicines and Spinraza Tell your doctor if you or your child are taking, have recently taken any, or might take any other medicines in future.

Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being given this medicine. It is preferable to avoid the use of Spinraza during pregnancy and breast-feeding.

Driving and using machines Spinraza has no or negligible influence on the ability to drive and use machines.

Spinraza contains a small amount of sodium This medicine contains less than 1 mmol sodium (23 mg) per 5 ml vial, that is to say essentially sodium-free and can be used by people on a sodium-restricted diet.

Spinraza contains a small amount of potassium This medicine contains potassium, less than 1 mmol (39 mg) per 5 ml vial, i.e. essentially potassium- free .

The usual dose of Spinraza is 12 mg.

Spinraza is given;

• On the first day of treatment, day 0
• Then around day 14, day 28 and day * Then once every 4 months.

Spinraza is given by injection into the lower back. This injection, called a lumbar puncture, is done by inserting a needle into the space around the spinal cord. This will be done by a doctor experienced in doing lumbar punctures. You or your child may also be given a medicine to make you relax or sleep during the procedure.

How long to use Spinraza Your doctor will tell you how long you or your child need to receive Spinraza. Don t stop treatment with Spinraza unless your doctor tells you to.

If you or your child misses an injection If you or your child miss a dose of Spinraza, speak with your doctor so that Spinraza can be given as soon as possible. If you have any questions about how Spinraza is given, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects related to the lumbar puncture may occur while Spinraza is being given or afterwards. The majority of these side effects are reported within 72 hours of the procedure.

Very common (may affect more than 1 in 10 people)

• Back pain
• Headache
• Vomiting

Additional side effects
Not known (frequency cannot be estimated from the available data)

• Serious infection related to lumbar puncture (e.g. meningitis)
• Hydrocephalus (a build-up of too much fluid around the brain)
• Meningitis not caused by an infection (inflammation of the membrane around the spinal cord and brain, which may present as neck stiffness, headache, fever, nausea and vomiting)
• Hypersensitivity (an allergic or allergic-like reaction that may include swelling of your face, lips or tongue, rash, or itching)

Reporting of side effects If you or your child get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly via:

Ireland HPRA Pharmacovigilance Website: www.hpra.ie

Malta ADR Reporting Website: www.medicinesauthority.gov.mt/adrportal

United Kingdom (Northern Ireland) Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

By reporting side effects you can help provide more information on the safety of this medicine.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the vial and carton after EXP . The expiry date refers to the last day of that month.

Store in a refrigerator (2 C to 8 C). Do not freeze. Keep the vial in the outer carton in order to protect from light. If no refrigeration is available, Spinraza may be stored in its original carton, protected from light at or below 30 C for up to 14 days.

Unopened vials of Spinraza can be removed from and returned to the refrigerator if necessary. If removed from the original carton, the total time out of refrigeration should not exceed 30 hours, at a temperature that does not exceed 25 C.

What Spinraza contains

• The active substance is nusinersen.
• Each 5 ml vial contains nusinersen sodium equivalent to 12 mg nusinersen.
• Each ml contains 2.4 mg of nusinersen.
• The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate, sodium chloride (see section 2 Spinraza contains a small amount of sodium ), potassium chloride (see section 2 Spinraza contains a small amount of potassium ), calcium chloride dihydrate, magnesium chloride hexahydrate, sodium hydroxide, hydrochloric acid, water for injections.

What Spinraza looks like and contents of the pack Spinraza is a clear colourless solution for injection. Each carton of Spinraza contains one vial. Each vial is for single use.

Marketing Authorisation Holder Biogen Netherlands B.V. Prins Mauritslaan 1171 LP Badhoevedorp The Netherlands

Manufacturer FUJIFILM Diosynth Biotechnologies Denmark ApS Biotek All 1 DK-3400 Hiller d Denmark

Biogen Netherlands B.V. Prins Mauritslaan 1171 LP Badhoevedorp The Netherlands

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Biogen Belgium N.V./S.A. T l/Tel: +32 2 219 12 Lietuva Biogen Lithuania UAB Tel: +370 5 259 6

Te .: +359 2 962 12 Luxembourg/Luxemburg Biogen Belgium N.V./S.A. T l/Tel: +32 2 219 12 esk republika Biogen (Czech Republic) s.r.o. Tel: +420 255 706 Magyarorsz g Biogen Hungary Kft. Tel.: +36 (1) 899 9Danmark Biogen (Denmark) A/S Tlf: +45 77 41 57 Malta Pharma MT limited Tel: +356 213 37008/9

Deutschland Biogen GmbH Tel: +49 (0) 89 99 6Nederland Biogen Netherlands B.V. Tel: +31 20 542 2Eesti Biogen Estonia O
Tel: + 372 618 9Norge Biogen Norway AS Tlf: +47 23 40 01
Genesis Pharma SA : +30 210 8771 sterreich Biogen Austria GmbH Tel: +43 1 484 46 Espa a Biogen Spain SL Tel: +34 91 310 7Polska Biogen Poland Sp. z o.o. Tel.: +48 22 351 51 France Biogen France SAS T l: +33 (0)1 41 37 95 Portugal Biogen Portugal Tel.: +351 21 318 8Hrvatska Biogen Pharma d.o.o. Tel: +385 (0) 1 775 73 Rom nia Ewopharma AG Representative Office Tel: + 40 377 881 Ireland Biogen Idec (Ireland) Ltd. Tel: +353 (0)1 463 7Slovenija Biogen Pharma d.o.o. Tel.: +386 1 511 02 sland Icepharma hf S mi: +354 540 8Slovensk republika Biogen Slovakia s.r.o. Tel.: +421 2 323 340 Italia Biogen Italia s.r.l. Tel: +39 02 584 9Suomi/Finland Biogen Finland Oy Puh/Tel: +358 207 401
Genesis Pharma Cyprus Ltd : +357 22765Sverige Biogen Sweden AB Tel: +46 8 594 113 Latvija Biogen Latvia SIA Tel: + 371 68 688 United Kingdom (Northern Ireland) Biogen Idec (Ireland) Limited Tel: +44 (0) 1628 50 1This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: