Abrysvo polvo y disolvente para solucion inyectable

Prospect: information for the user

Abrysvo powder and solvent for injectable solution

Respiratory syncytial virus vaccine (bivalent, recombinant)

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before starting to receive this vaccine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they are possible adverse effects not listed in this prospect. See section 4.

Abrysvo is a vaccine to prevent respiratory disease (of the respiratory tract) caused by a virus called the respiratory syncytial virus (RSV). Abrysvo is administered to:

• pregnant women to protect their babies from birth to 6 months of age,

or

• individuals 18 years of age and older.

The RSV is a common virus that, in most cases, causes mild symptoms similar to those of a cold, such as sore throat, cough, or nasal congestion. However, in small infants, the RSV can cause severe respiratory problems. In older adults and individuals with chronic conditions, the RSV can worsen diseases such as chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). The RSV can lead to hospitalization in severe cases and, in some circumstances, can be fatal.

How Abrysvo works

This vaccine helps the immune system (the body's natural defenses) to produce antibodies (substances in the blood that help the body fight infections) that protect against respiratory disease caused by the RSV. In pregnant women vaccinated between weeks 24 and 36 of pregnancy, these antibodies pass to the baby through the placenta before birth, protecting babies when they are at greater risk of contracting the RSV.

Do not administer Abrysvo

• if you are allergic to the active ingredients or to any of the other components of this vaccine (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before receiving this vaccine

• If you have ever had a severe allergic reaction or respiratory problems after receiving another vaccine or after receiving Abrysvo in the past.
• If you feel anxious about receiving the vaccine or if you have ever fainted after an injection. Fainting can occur before or after any injection.
• If you have a high fever infection. If this is the case, vaccination will be postponed. There is no need to delay vaccination for a mild infection, such as a cold, but consult your doctor first.
• If you have a bleeding disorder or if you bruise easily.
• If you have a weakened immune system that may prevent you from getting all the benefits of Abrysvo.
• If you are less than 24 weeks pregnant.

If any of the above situations apply (or you are unsure), consult your doctor, pharmacist, or nurse before receiving Abrysvo.

Like any vaccine, Abrysvo may not protect everyone who receives it completely.

Children and adolescents

Abrysvo is not recommended for children and young people under 18 years of age, except during pregnancy (see the section “Pregnancy” below).

Other medicines and Abrysvo

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medicine or have received recently any other vaccine.

Abrysvo can be administered at the same time as the flu or COVID-19 vaccine. It is recommended to have a gap of at least two weeks between the administration of Abrysvo and the tetanus, diphtheria, and acellular pertussis vaccine.

Pregnancy and breastfeeding

Pregnant women can receive this vaccine at the end of the second or third trimester (weeks 24 to 36). If you are breastfeeding, consult your doctor or nurse before receiving this vaccine.

Driving and operating machinery

It is unlikely that Abrysvo will affect your ability to drive or operate machinery.

Abrysvo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; it is essentially “sodium-free”.

You will receive an injection of 0.5 ml in a muscle of the upper arm.

If you have any questions about the use of Abrysvo, consult your doctor, pharmacist, or nurse.

Like all vaccines, this vaccine may cause side effects, although not all people will experience them.

Severe side effects

Very rare(may affect up to1 in 10,000 people)

• Severe allergic reactions: signs of a severe allergic reaction include swelling of the face, lips, tongue, or throat, difficulty breathing or swallowing, and dizziness. See also section2.
• Guillain-Barré syndrome (a neurological disorder that usually begins with tingling and weakness in the extremities and may progress to paralysis of part or all of the body).

Inform your doctor immediately if you notice signs of these severe side effects.

The following side effects have been reported in pregnant women

Very common(may affect more than1 in 10 people)

• Pain at the injection site
• Headache
• Muscle pain (myalgia).

Common(may affect up to1 in 10 people)

• Redness at the injection site
• Swelling at the injection site.

Rare(may affect up to1 in 1,000 people)

•Allergic reactions such as rash or urticaria

•Lymph node inflammation (lymphadenopathy).

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

The following side effects have been reported in people aged 18years and older

Very common(may affect more than1 in 10 people)

• Fatigue (fatigue)
• Headache
• Pain at the injection site
• Muscle pain (myalgia).

Common(may affect up to1 in 10 people)

• Joint pain (arthralgia)
• Redness at the injection site
• Swelling at the injection site.

Uncommon(may affect up to1 in 100 people)

• Fever (pyrexia).

Rare(may affect up to1 in 1,000 people)

• Allergic reactions such as rash or urticaria
• Lymph node inflammation (lymphadenopathy)
• Cardinal signs at the injection site (hematoma)
• Itching at the injection site (pruritus).

Very rare(may affect up to1 in 10,000 people)

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and label after EXP. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2 °C and 8 °C).

Do not freeze. Discard if the packaging has frozen.

After reconstitution, Abrysvo must be administered immediately or within 4 hours if stored between 15 °C and 30 °C. Do not freeze.

Composition of Abrysvo

The active principles are:

Stabilized F antigen in prefusion state of subgroup A of VRS1,260 micrograms

Stabilized F antigen in prefusion state of subgroup B of VRS1,260 micrograms

(VRS antigens)

1 glycoprotein F stabilized in prefusion conformation.

2 produced in Chinese hamster ovary cells (OHC) by recombinant DNA technology.

The other components are:

Dry Powder

• trometamol
• hydrochloride of trometamol
• sucrose
• mannitol (E421)
• polysorbate80 (E433)
• sodium chloride
• hydrochloric acid

Vehicle

• water for injection

Appearance of the product and contents of the container

Abrysvo is provided as:

• white powder in a glass vial
• vehicle in a pre-filled syringe or a vial for dissolving the powder.

After dissolving the powder in the vehicle, the solution is transparent and colorless.

Abrysvois available in:

• a pack containing 1vial of powder, 1pre-filled syringe of vehicle, 1adapter of the vial with 1needle or without needles (pack of 1 dose);
• a pack containing 5vials of powder, 5pre-filled syringes of vehicle, 5adapters of the vial with 5needles or without needles (pack of 5 doses);
• a pack containing 10vials of powder, 10pre-filled syringes of vehicle, 10adapters of the vial with 10needles or without needles (pack of 10 doses);
• a pack containing 5vials of powder and 5vials of vehicle (pack of 5 doses).
• a pack containing 10vials of powder and 10vials of vehicle (pack of 10 doses).

Only some pack sizes may be commercially available.

Marketing Authorization Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Bruxelles

Belgium

Responsible for Manufacturing

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs-Sint-Amands

Belgium

Pfizer Ireland Pharmaceuticals

Grange Castle Business Park

Clondalkin, Dublin 22

Ireland

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Last update of this leaflet:02/2025

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:https://www.ema.europa.eu

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This information is intended solely for healthcare professionals:

Traceability

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

Administration

Abrysvo can only be administered by intramuscular injection.

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

Storage of the reconstituted vaccine

Abrysvo must be administered immediately after reconstitution or within 4hours. Store the reconstituted vaccine between 15°C and 30°C. Do not freeze the reconstituted vaccine.

Chemical and physical stability has been demonstrated for 4hours between 15°C and 30°C. From a microbiological point of view, the vaccine must be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user.

Preparation for administration

For use of the antigen vial for Abrysvo (powder), pre-filled syringe with vehicle and vial adapter

The powder must be reconstituted only with the vehicle provided in the pre-filled syringe using the vial adapter.

The prepared vaccine is a transparent and colorless solution. Visually inspect the vaccine to detect large particles and color changes before administration. Do not use it if you observe large particles or color changes.

For use of the vial of antigens for Abrysvo (powder) and the vial of vehicle

The powder must be reconstituted only with the vial of vehicle provided.

1. Using a sterile needle and syringe, extract all the contents of the vial of vehicle and inject all the contents of the syringe into the vial of powder.
2. Gently shake the vial with circular movements until the powder is completely dissolved. Do not shake.
3. Extract 0.5ml from the vial with the reconstituted vaccine. The prepared vaccine is a transparent and colorless solution. Visually inspect the vaccine to detect large particles and color changes before administration. Do not use it if you observe large particles or color changes.

Disposal

The disposal of unused product and all materials that have been in contact with it will be carried out in accordance with local regulations.