Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - beyfortus

Document Subject

Generated Narrative: MedicinalProductDefinition mpa66c014f097e72b89c0a0ea0e94b80cb

identifier: http://ema.europa.eu/identifier/EU/1/22/1689/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Beyfortus 50 mg solution for injection in pre-filled syringe

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-a66c014f097e72b89c0a0ea0e94b80cb

identifier: http://ema.europa.eu/identifier/EU/1/22/1689/001

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - beyfortus

Attesters

What is in this leaflet

1. What Beyfortus is and what it is used for
2. What you need to know before your 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

What Beyfortus is Beyfortus is a medicine given as an injection to protect babies 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 and older adults, RSV can cause severe illness, including bronchiolitis (inflammation of the small airways in the lung) and 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.

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 if 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:

difficulty breathing or swallowing

swelling of the face, lips, tongue or throat

severe itching of the skin, with a red rash or raised bumps Talk to your healthcare provider 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). 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 medicines 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.

Beyfortus is given by a doctor, pharmacist or nurse as a single 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. Beyfortus should be given before the RSV season. The virus is usually more common during 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 operation 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.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Side effects can include: Uncommon (may affect up to 1 in 100 children)

rash

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

fever 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.

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.

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, 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 82 avenue Raspail 94250 Gentilly France Manufacturer AstraZeneca AB G rtunav gen SE-151 85 S dert lje Sweden For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Belgi /Belgique/Belgien Sanofi Belgium T l/Tel: +32 2 710.54.Lietuva Swixx Biopharma UAB Tel: +370 5 236 91
Swixx Biopharma EOOD .: +359 2 4942 Luxembourg/Luxemburg Sanofi Belgium T l/Tel: +32 2 710.54. esk republika Sanofi Pasteur divize. vakc n sanofi-aventis, s.r.o. Tel: +420 233 086 Magyarorsz g sanofi-aventis zrt Tel.: +36 1 505 0Danmark Sanofi A/S Tlf: +45 4516 7Malta Sanofi S.r.l. Tel: +39 02 39394Deutschland Sanofi-Aventis Deutschland GmbH Tel.: 0800 54 54 Tel. aus dem Ausland: +49 69 305 21 Nederland Genzyme Europe B.V. Tel: +31 20 245 4Eesti Swixx Biopharma O
Tel: +372 640 10 Norge Sanofi-aventis Norge AS Tlf: + 47 67 10 71
. . : +30.210.8009 sterreich Sanofi-Aventis GmbH Tel: +43 1 80 185-0 Espa a sanofi-aventis, S.A. Tel: +34 93 485 94 Polska Sanofi Pasteur Sp. z o. o. Tel.: +48 22 280 00 France Sanofi Pasteur Europe T l: 0800 42 43 Appel depuis l tranger : +33 1 57 63 67 Portugal Sanofi Produtos Farmac uticos, Lda. Tel: + 351 21 35 89 Hrvatska Swixx Biopharma d.o.o. Tel: +385 1 2078 Rom nia Sanofi Romania SRL Tel: +40(21) 317 31 Ireland sanofi-aventis Ireland T/A SANOFI Tel: + 353 (0) 1 4035 Slovenija Swixx Biopharma d.o.o Tel: +386 1 235 51 sland Vistor S mi: +354 535 7Slovensk republika Swixx Biopharma s.r.o. Tel: +421 2 208 33 Italia Sanofi S.r.l. Tel: 800536Tel dall'estero: +39 02 39394Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200
C.A. Papaellinas Ltd. : +357 22 741Sverige Sanofi AB Tel: +46 8-634 50 Latvija Swixx Biopharma SIA Tel: +371 6 616 47 United Kingdom (Northern Ireland) sanofi-aventis Ireland Ltd. T/A SANOFI Tel: +44 (0) 800 035 2This leaflet was last revised in Detailed information on this medicine is available on the European Medicines Agency web site: