InfoCons Consumer Protection informs you – Abrysvo – Package Leaflet

Before anything else

Read all of this leaflet carefully before you recei ve this vaccine 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, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

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

Abrysvo is a vaccine to prevent lung (respirator y tract) disease caused by a virus called respiratory syncytial virus (RSV). Abrysvo is given to:

• pregnant individuals to protect their infants from birth through 6 months of age or
• individuals 18 years of age and older.

RSV is a common virus which, in most cases, causes mild, cold-like symptoms such as a sore throat, cough or a blocked nose. However, in young infant s RSV can cause serious lung problems. In older adults and people with chronic medical cond itions, RSV can worsen illnesses such as chronic obstructive pulmonary disease (COPD) and conges tive heart failure (CHF). RSV can lead to hospitalisation in severe cases and in some cases it can be fatal.

How Abrysvo works

This vaccine helps the immune system (the body’s natural defences) to make antibodies (substances in the blood that help the body fight infections) which protect against lung disease caused by RSV. In pregnant individuals who are v accinated between weeks 24 and 36 of pregnancy, these antibodies are passed to the infant through the placenta before birth which protects infants when they are at most risk from RSV.

⚠️ 2. What you need to know before you receive Abrysvo

Abrysvo should not be given

• if you are allergic to the active s ubstances or any of the other ingr edients of this vaccine (listed in section 6).

45 Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given this vaccine

• if you have ever had a severe allergic reac tion or breathing problems after you received any other vaccine injection or after you were given Abrysvo in the past.
• if you are feeling nervous about getting the vaccine or have ever fainted after any injection.

Fainting can happen before or after any injection.

• if you have an infection with a high fever. If this is the case, then vaccination will be postponed. There is no need to delay vaccination fo r a minor infection, such as a cold, but talk to your doctor first.
• if you have a bleeding problem or bruise easily.
• if you have a weakened immune system whic h may prevent you from getting the full benefit from Abrysvo.
• if you are less than 24 weeks pregnant.

If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Abrysvo. As with any vaccine, Abrysvo may not fu lly protect all those who receive it.

Children and adolescents Abrysvo is not recommended in children and y oung people below 18 years of age except during pregnancy (see ‘Pregnancy’ section below). Other medicines and Abrysvo Tell your doctor or pharmacist if you are using, ha ve recently used or might use any other medicines or have recently received any other vaccine. Abrysvo may be given at the same time as a flu vacci ne or a COVID-19 vaccine. A gap of at least two weeks is recommended between administration of Abrysvo and administration of a vaccine against tetanus, diphtheria and acellular pertussis (whooping cough).

Pregnancy and breast-feeding Pregnant individuals can be given this vaccine in the late second or third trimester (weeks 24 to 36).

Talk to your doctor or nurse for advice before getting this vaccine if you are breast-feeding.

Driving and using machines

Abrysvo is unlikely to affect your ability to drive or use machines.

Abrysvo contains sodium This medicine contains less than 1 mmol sodi um (23 mg) per dose, that is to say essentially ‘sodium-free’.

Abrysvo contains polysorbate 80 This medicine contains 0.08 mg of polysorbat e 80 in each dose. Polysorbates may cause allergic reactions. Tell your doctor if you have any known allergies.

💊 3. How Abrysvo is given You will be given one injection of 0.5 mL into a muscle of your upper arm.

If you have any questions on the use of Abry svo, ask your doctor, pharmacist or nurse.

❗ 4. Possible side effects

Like all vaccines, this vacc ine can cause side effects, although not everybody gets them.

Serious side effects

Very rare (may affect up to 1 in 10 000 people)

• severe allergic reactions – signs of a severe alle rgic reaction include swelling of the face, lips, tongue or throat, difficulty breathing or swallowing and dizziness. See also section 2.
• Guillain-Barré syndrome (a neurological disorder th at usually starts with pins and needles and weakness of the limbs and ma y progress up to paralysis of part or all of the body).

Tell your doctor immediately if you noti ce signs of these serious side effects.

The following side effects were reported in pregnant individuals Very common (may affect more than 1 in 10 people)

• pain where the injection is given
• headache
• muscle pain (myalgia).

Common (may affect up to 1 in 10 people)

• redness where the injection is given
• swelling where the injection is given.

Rare (may affect up to 1 in 1 000 people)

• allergic reactions such as rash or hives
• swollen glands (lymphadenopathy).

No side effects were reported in infants born to vaccinated mothers.

The following side effects were reported in individuals 18 years of age and older Very common (may affect more than 1 in 10 people)

• tiredness (fatigue)
• headache
• pain where the injection is given
• muscle pain (myalgia).

Common (may affect up to 1 in 10 people)

• joint pain (arthralgia)
• redness where the injection is given
• swelling where the injection is given.

Uncommon (may affect up to 1 in 100 people)

• fever (pyrexia).

Rare (may affect up to 1 in 1 000 people)

• allergic reactions such as rash or hives
• swollen glands (lymphadenopathy)
• bruising where the injection is given (haematoma)
• itching where the injection is given (pruritus).

Very rare (may affect up to 1 in 10 000 people)

• severe allergic reactions (see Serious side effects, above)
• Guillain-Barré syndrome (see Serious side effects, above).

47 Reporting of side effects If you get 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 Abrysvo Keep this medicine out of th e sight and reach of children.

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

Store in a refrigerator (2 ºC – 8 ºC). Do not freeze. Discard if the carton has been frozen.

After reconstitution, store in a refrigerator (2 °C to 8 °C). Administer within 8 hours with no more than 4 hours stored at room temperature (up to 30 °C).

📦 6. Contents of the pack and other information

What Abrysvo contains The active substances are

RSV subgroup A stabilised prefusion F antigen 1,2 60 micrograms RSV subgroup B stabilised prefusion F antigen1,2 60 micrograms (RSV antigens) 1glycoprotein F stabilised in the prefusion conformation 2produced in Chinese Hamster Ovary cells by recombinant DNA technology.

The other ingredients are:

Powder

• trometamol
• trometamol hydrochloride
• sucrose
• mannitol (E421)
• polysorbate 80 (E433)
• sodium chloride
• hydrochloric acid Solvent
• water for injections
• 2-phenoxyethanol

What Abrysvo looks like and contents of the pack

Abrysvo is provided as

• a white powder in a multidose glass vial
• a solvent in a multidose vi al to dissolve the powder After dissolving the powder in the solvent, the solution is clear and colourless. The maximum number of doses per vial is 3.

Abrysvo is available in a carton containing 10 multidose vials of powder and 10 multidose vials of solvent (30 dose pack).

Marketing Authorisation Holder

Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgium Manufacturer Pfizer Manufacturing Belgium NV Rijksweg 12 2870 Puurs-Sint-Amands Belgium For any information about this medicine, please c ontact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Luxembourg/Luxemburg Pfizer NV/SA Tél/Tel: + 32 (0)2 554 62 11 Latvija Pfizer Luxembourg SARL fili āle Latvijā Tel.: + 371 670 35 775 България Пфайзер Люксембург САРЛ , Клон България Teл: +359 2 970 4333 Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel: +370 5 251 4000 Česká republika Pfizer, spol. s r.o.

Tel: +420 283 004 111 Magyarország Pfizer Kft Tel: + 36 1 488 37 00 Danmark Pfizer ApS Tlf.: + 45 44 20 11 00 Malta Vivian Corporation Ltd. Tel: + 356 21344610 Deutschland PFIZER PHARMA GmbH Tel: +49 (0)30 550055-51000 Nederland Pfizer bv Tel: +31 (0)800 63 34 636 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel: +372 666 7500 Norge Pfizer AS Tlf: +47 67 52 61 00 Ελλάδα Pfizer Ελλάς A.E.

Τηλ.: +30 210 6785800 Österreich Pfizer Corporation Austria Ges.m.b.H Tel: +43 (0)1 521 15-0 España Pfizer, S.L.

Télf: +34 91 490 99 00 Polska Pfizer Polska Sp. z o.o.

Tel.: +48 22 335 61 00 France Pfizer Tél +33 (0)1 58 07 34 40 Portugal Laboratórios Pfizer, Lda.

Tel: +351 21 423 5500 49 Hrvatska Pfizer Croatia d.o.o.

Tel: + 385 1 3908 777 România Pfizer Romania S.R.L Tel: +40 (0) 21 207 28 00 Ireland Pfizer Healthcare Ireland Unlimited Company Tel: +1800 633 363 (toll free) Tel: +44 (0)1304 616161 Slovenija Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s podro čja farmacevtske dejavnosti, Ljubljana Tel.: +386 (0)1 52 11 400 Ísland Icepharma hf. Simi: + 354 540 8000 Slovenská republika Pfizer Luxembourg SARL, organizačná zložka Tel: + 421 2 3355 5500 Italia Pfizer S.r.l. Tel: +39 06 33 18 21 Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 040 Kύπρος Pfizer Ελλάς Α.Ε. (Cyprus Branch) Tηλ: +357 22817690 Sverige Pfizer AB Tel: +46 (0)8 550 520 00

This leaflet was last revised in

Other sources of information Detailed information on this medicine is availa ble on the European Medicines Agency web site: https://www.ema.europa.eu ————————————————————————————————————————— The following information is intende d for healthcare professionals only:

Traceability In order to improve the traceability of biological medicinal products, the na me and the batch number of the administered product should be clearly recorded.

Administration Abrysvo is for intramuscular use only.

The unopened vial is stable for 5 days when stored at temperatures from 8 °C to 30 °C. At the end of this period Abrysvo should be used or discarded. This information is u sed to guide healthcare professionals in case of temporary temperature excursions only.

Storage of reconstituted vaccine After reconstitution, store in a refrigerator (2 °C to 8 °C). Abrysvo should be administered within 8 hours with no more than 4 hours stored at room temperature (up to 30 °C). Do not freeze.

50 Preparation for administration Abrysvo powder and solvent for solution for injection in multidose container Multidose vials The multidose vial containing antigens for Abrysvo (powder) must be reconstituted only with the multidose vial of solvent provided to form Abrys vo. Abrysvo is administered as a single dose of 0.5 mL. The maximum number of doses per multidose vial is 3.

Preparation for administration 1. Using a sterile needle and sterile syringe, withdraw the entire contents of the vial containing the solvent and inject the entire contents of the syringe into the vial containing the powder.

2. Gently swirl the vial in a circular motion until th e powder is completely dissolved. Do not shake.

Withdraw 0.5 mL (1 dose) from the vial containing the reconstituted vaccine.

3. Repeat step 2 using a new sterile needle and st erile syringe to withdraw additional 0.5 mL doses from the vial containing the reconstituted vaccine. The maximum number of doses per multidose vial is 3. After preparing 3 doses, dispose of any unused vaccine.

The prepared vaccine is a clear and colourless so lution. Visually inspect the vaccine for large particulate matter and discolouration prior to administ ration. Do not use if large particulate matter or discolouration is found.

Disposal Any unused product or waste material should be disp osed of in accordance with local requirements.

📄 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 Abrysvo (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/23/1752).

⚠️ 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.