InfoCons Consumer Protection informs you – Beyfortus – Package Leaflet

Before anything else

Read all of this leaflet carefully before you r child is given this medicine because it contains important information for you and your child .

• Keep this leaflet. You may need to read it ag ain.
• If you have any further questions, ask your doctor , pharmacist or nurse.
• If you r child gets any side effects, talk to your doctor , pharmacist or nurse. This includes any possible side effects not listed in this leaflet . See section 4.

What is in th is leaflet 1. What Beyfortus is and what it is used for 2. What you need to know before you r child is given Beyfortus 3. How and when Beyfortus is given 4. Possible side effects 5. How to store Beyfortus 6. Contents of the pack and other information

ℹ️ 1. What Beyfortus is and what it is used for

What Beyfortus is Beyfortus is a medicine given as an injection to protect babies and children less than 2 years of age against respiratory syncytial virus (RSV). RSV is a common respiratory virus that usually causes mild symptoms comparable to the common cold. However, especially in babies , vulnerable children and older adults, RSV can cause severe illness, including bronchiolitis (inflammation of the small airways in the lung) an d pneumonia (infection of the lungs) that may lead to hospitalisation or even death. The virus is usually more common during the winter.

Beyfortus contains the active ingredient nirsevimab which is an antibody (a protein designed to attach to a specific target) that attaches to a protein that RSV needs to infect the body. By attaching to this protein, Beyfortus blocks its action, thereby stopping the virus from entering and infecting human cells.

What Beyfortus is used for

Beyfortus is a medicine to protect your child from getting RSV disease .

⚠️ 2. What you need to know before your child is given Beyfortus

Your child should not use Beyfortus if he or she is allergic to nirsevimab or any of the other ingredients of this medicine (listed in section 6).

Inform your child’s doctor, pharmacist or nurse i f this applies to your child . If you are not sure , check with your child’s doctor , pharmacist or nurse before the medicine is given .

If your child shows signs of a severe allergic reaction contact the doctor immediately .

Warnings and precautions

Tell your doctor or seek medical help immediately if you notice any signs of an allergic reaction , such as:

29 • difficulty breathing or swallow ing

• swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or raised bumps Talk to your healthcare pro fessional before your child is given Beyfortus if they have low numbers of blood platelets (which help blood clotting), a bleeding problem or bruise easily or if they are taking an anticoagulant (a medicine to prevent blood clots).

In certain chronic health conditions, where too much protein is lost via the urine or the gut, for example nephrotic syndrome and chronic liver disease, the level of protection of Beyfortus may be reduced.

Beyfortus contains 0.1 mg of polysorbate 80 in each 50 mg (0.5 mL) dose and 0.2 mg in each 100 mg (1 mL) dose. Polysorbate s may cause allergic reactions. Tell your doctor if your child has any known allergies.

Children and adolescents

Do not give this medicine to children between the age of 2 and 18 years of age because it has not been studied in this group.

Other medicin es and Beyfortus Beyfortus is not known to interact with other medicines. However, tell your doctor , pharmacist or nurse if your child is taking, has recently taken or might take any other medicines .

Beyfortus may be given at the same time as vaccines that are part of the national immunisation program .

💊 3. How and when Beyfortus is given

Beyfortus is given by a healthcare professional as an injection in the muscle. It is usually given in the outer part of the thigh.

The recommended dose is :

• 50 mg for children weighing less than 5 kg and 100 mg for children weighing 5 kg or more in their first RSV season .
• 200 mg for children who remain vulnerable to severe RSV disease in their second RSV season (given as 2 x 100 mg injections at separate sites) .

Beyfortus should be given before the RSV season. The virus is usually more common d uring the winter (known as the RSV season). If your child is born during the winter , Beyfortus should be given after birth.

If your child is to have a heart operation (cardiac surgery), he or she may be given an extra dose of Beyfortus after the operati on to ensure they have adequate protection over the remainder of the RSV season .

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

❗ 4. Possible side effects

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

Side effects can include:

30 Uncommon (may affect up to 1 in 10 0 children)

• rash
• injection site reaction (i.e. redness, swelling, and pain where the injection is given )
• fever

Not known (cannot be estimated from available data)

• allergic reactions

Reporting of side effects

If your child gets any side effects , talk to your doctor , pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.

🌡️ 5. How to store Beyfortus

Your doctor, pharmacist or nurse is responsible for storing this medicine and disposing of any unused product correctly. The following information is intended for healthcare professionals .

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 carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C). After removal from the refrigerator, Beyfortus must be protected from light and used within 8 hours or discarded.

Keep the pre -filled syringe in the outer carton in order to protect from light.

Do not freeze, shake or expose to direct heat.

Any unused medicine or waste material should be disposed of in accordance with local requirements.

📦 6. Contents of the pack and other information

What Beyfortus contains

• The active substance is nirsevimab.
• One pre -filled syringe of 0.5 mL solution contains 50 mg nirsevimab.
• One pre -filled syringe of 1 mL solution contains 100 mg nirsevimab.
• The other ingredients are L -histidine, L -histidine hydrochloride, L -arginine hydrochloride, sucrose, polysorbate 80 (E433) , and water for injections .

What Beyfortus looks like and contents of the pack

Beyfortus is a colourless to yellow solution for injection.

Beyfortus is available as:

• 1 or 5 pre -filled syringe (s) without needles.
• 1 pre -filled syringe packaged with two separate needles of different sizes.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Sanofi Winthrop Industrie 31 82 avenue Raspail 94250 Gentilly France

Manufacturer

AstraZeneca AB Karlebyhusentren, Astraallen 152 57 Södertälje Sweden For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Sanofi Belgium Tél/Tel: +32 2 710.54.00 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91 40 България Swixx Biopharma EOOD Тел.: +359 2 4942 480 Luxembourg/Luxemburg Sanofi Belgium Tél/Tel : +32 2 710.54.00 Česká republika Sanofi s.r.o.

Tel: +420 233 086 111 Magyarország sanofi -aventis zrt Tel.: +36 1 505 0055 Danmark Sanofi A/S Tlf: +45 4516 7000 Malta Sanofi S.r.l.

Tel: +39 02 39394275 Deutschland Sanofi -Aventis Deutschland GmbH Tel.: 0800 54 54 010 Tel. aus dem Ausland: +49 69 305 21 130 Nederland Sanofi B.V.

Tel: +31 20 245 4000 Eesti Swixx Biopharma OÜ Tel: +372 640 10 30 Norge Sanofi -aventis Norge AS Tlf: + 47 67 10 71 00 Ελλάδα ΒΙΑΝΕΞ Α.Ε.

Τηλ: +30.210.8009111 Österreich Sanofi -Aventis GmbH Tel: +43 1 80 185-0 España sanofi -aventis, S.A.

Tel: +34 93 485 94 00 Polska Sanofi Sp. z o. o.

Tel.: +48 22 280 00 00 France Sanofi Winthrop Industrie Tél: 0 800 222 555 Appel depuis l’étranger : +33 1 57 63 23 23 Portugal Sanofi – Produtos Farmacêuticos, Lda.

Tel: + 351 21 35 89 400 Hrvatska Swixx Biopharma d.o.o.

Tel: +385 1 2078 500 România Sanofi Romania SRL Tel: +40(21) 317 31 36 Ireland sanofi -aventis Ireland T/A SANOFI Slovenija Swixx Biopharma d.o.o 32 Tel: + 353 (0) 1 4035 600 Tel: +386 1 235 51 00 Ísland Vistor Sími: +354 535 7000 Slovenská republika Swixx Biopharma s.r.o.

Tel: +421 2 208 33 600 Italia Sanofi S.r.l.

Tel: 800536389 Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300 Κύπρος C.A. Papaellinas Ltd.

Τηλ: +357 22 741741 Sverige Sanofi AB Tel: +46 8 -634 50 00 Latvija Swixx Biopharma SIA Tel: +371 6 616 47 50 United Kingdom (Northern Ireland) sanofi -aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2525

This leaflet was last revised i n

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu . ———————————————————————————————- —————————–

🩺 Information intended for healthcare professionals only

In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recor ded.

Visually inspect Beyfortus for particulate matter and discolo uration prior to administration. Beyfortus is a clear to opalescent, colourless to yellow solution . Do not inject Beyfortus if the liquid is cloudy, discoloured, or it contains large parti cles or foreign particulate matter.

Do not use if the Beyfortus pre-filled syringe has been dropped or damaged or the security seal on the carton has been broken.

Administer the entire contents of the pre -filled syringe as an intramuscular injection, preferably in the anterolateral aspect of the thigh. The gluteal muscle should not be used routinely as an injection site because of the risk of damage to the sciatic nerve.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Beyfortus (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/22/1689).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.