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ABRYSVO powder and solvent for injectable solution

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About the medicine

How to use ABRYSVO powder and solvent for injectable solution

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Abrysvo Powder and Solvent for Solution for Injection

vaccine against respiratory syncytial virus (bivalent, recombinant)

This medicine is subject to additional monitoring, which will allow for the rapid detection of new safety information. You can help by reporting any side effects you may have. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you start receiving 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 experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

  1. What is Abrysvo and what is it used for
  2. What you need to know before you receive Abrysvo
  3. How Abrysvo is administered
  4. Possible side effects
  5. Storage of Abrysvo
  6. Contents of the pack and further information

1. What is Abrysvo and what is it used for

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

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

or

  • people aged 18 years and older.

RSV is a common virus that, in most cases, causes mild symptoms similar to those of a cold, such as sore throat, cough, or runny nose. However, in small infants, RSV can cause serious lung problems. In older adults and people with chronic conditions, RSV can worsen diseases such as chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). 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 lung disease caused by RSV. In pregnant women vaccinated between 24 and 36 weeks of pregnancy, these antibodies pass to the baby through the placenta before birth, protecting the babies when they are most at risk of contracting RSV.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you start receiving Abrysvo

Abrysvo must not be administered

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you are given this vaccine

If any of the above situations apply to you (or you are not sure), talk to your doctor, pharmacist, or nurse before you are given Abrysvo.

As with any vaccine, it is possible that Abrysvo may not completely protect everyone who receives it.

Children and adolescents

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

Other medicines and Abrysvo

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine or have recently received any other vaccine.

Abrysvo can be administered at the same time as the flu vaccine or the COVID-19 vaccine. It is recommended to leave an interval of at least two weeks between the administration of Abrysvo and the tetanus, diphtheria, and 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, talk to your doctor or nurse before receiving this vaccine.

Driving and using machines

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

Abrysvo contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; i.e., it is essentially "sodium-free".

Abrysvo contains polysorbate 80

A dose of Abrysvo contains 0.08 mg of polysorbate 80. Polysorbates can cause allergic reactions. Tell your doctor if you have any known allergy.

3. How Abrysvo is administered

You will be given an injection of 0.5 ml into a muscle in the upper arm.

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

Medicine questions

Started taking the medicine and have questions?

Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all vaccines, this vaccine 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: the signs of a severe allergic 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 that usually starts with tingling and weakness in the limbs and can progress to paralysis of part or all of the body).

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

The following side effects have been reported in pregnant women

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

  • pain at the injection site
  • headache
  • muscle pain (myalgia).

Common(may affect up to 1 in 10 people)

  • redness at the injection site
  • swelling at the injection site.

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

  • allergic reactions such as rash or hives
  • inflammation of the glands (lymphadenopathy).

No side effects have been reported in infants born to vaccinated mothers.

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

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

  • fatigue
  • headache
  • pain at the injection site
  • muscle pain (myalgia).

Common(may affect up to 1 in 10 people)

  • joint pain (arthralgia)
  • redness at the injection site
  • swelling at the injection site.

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
  • inflammation of the glands (lymphadenopathy)
  • bruising at the injection site (hematoma)
  • itching at the injection site (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).

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through 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. Storage of Abrysvo

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 and label after EXP. The expiry date is the last day of the month shown.

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

Do not freeze. Discard if the pack has been frozen.

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

6. Container Contents and Additional Information

Composition of Abrysvo

The active ingredients are:

Stabilized F antigen in pre-fusion of subgroup A of VRS1,2 60 micrograms

Stabilized F antigen in pre-fusion of subgroup B of VRS1,2 60 micrograms

(VRS antigens)

1stabilized F glycoprotein in the pre-fusion conformation.

2produced in Chinese hamster ovary (CHO) cells using recombinant DNA technology.

The other components are:

Powder

  • tromethamine
  • hydrochloride tromethamine
  • sucrose
  • mannitol (E421)
  • polysorbate 80 (E433)
  • sodium chloride
  • hydrochloric acid

Solvent

  • water for injectable preparations

Appearance of the Product and Container Contents

Abrysvo is provided as:

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

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

Abrysvo is available in:

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

Only some pack sizes may be marketed.

Marketing Authorization Holder

Pfizer Europe MA EEIG

Boulevard de la Plaine 17

1050 Brussels

Belgium

Manufacturer

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs-Sint-Amands

Belgium

Pfizer Ireland Pharmaceuticals

Grange Castle Business Park

Clondalkin, Dublin 22

Ireland

You can request more information about this medicinal product by contacting the local representative of the marketing authorization holder:

België/Belgique/Belgien

Luxembourg/Luxemburg

Pfizer NV/SA

Tel: + 32 (0)2 554 62 11

Latvija

Pfizer Luxembourg SARL filiale Latvija

Tel.: + 371 670 35 775

Text in a foreign language with contact information for Pfizer Luxembourg SARL, including address and phone number

Lietuva

Pfizer Luxembourg SARL

filialas Lietuvoje

Tel: +370 5 251 4000

Ceská 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.

Tel: +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

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 podrocja

farmacevtske dejavnosti,

Ljubljana

Tel.: +386 (0)1 52 11 400

Ísland

Icepharma hf.

Simi: + 354 540 8000

Slovenská republika

Pfizer Luxembourg SARL, organizacná 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

Κύπρος

Pfizer Ελλάς Α.Ε. (Cyprus Branch)

Τηλ: +357 22817690

Sverige

Pfizer AB

Tel: +46 (0)8 550 520 00

Date of Last Revision of this Leaflet:04/2025.

Other Sources of Information

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

--------------------------------------------------------------------------------------------------------------

This information is intended for healthcare professionals only:

Traceability

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

Administration

Abrysvo can only be administered via the intramuscular route.

The unopened vial is stable for 5 days when stored at temperatures between 8 °C and 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 should be administered immediately after reconstitution or within 4 hours. Store the reconstituted vaccine between 15 °C and 30 °C. Do not freeze the reconstituted vaccine.

Chemical and physical stability has been demonstrated for 4 hours between 15 °C and 30 °C. From a microbiological point of view, the vaccine should 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 with the Abrysvo antigen vial (powder), pre-filled syringe with solvent, and vial adapter

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

Pre-filled Syringe with Solvent for Abrysvo

Vial with Abrysvo Antigens (Powder)

Vial Adapter

Transparent pre-filled syringe with gray plunger and black needle connected and ready for use

Medicine vial with stopper and an enlarged circle showing the detail of the rubber closure for puncture

Hypodermic needle with bevel and straight end showing the sharp tip and the silver-plated metal cylinder

Syringe Cap

Luer Lock Adapter

Vial Stopper (without the removable closure cap)

Hands holding a vial and a needle adapter preparing for injection, black arrow indicating direction

Step1. Place the Vial Adapter

  • Remove the upper cover of the vial adapter package and remove the removable closure cap from the vial.
  • While keeping the vial adapter in its package, center it over the vial stopper and connect it by pushing it down. Do not push the vial adapter at an angle, as this may cause leaks. Remove the package.

Hand holding an auto-injector with an arrow indicating pressure and a circular arrow showing rotation

Step2. Reconstitute the Powder Component (Antigens) to Form Abrysvo

  • For all steps of assembling the syringe, hold the syringe only by the Luer Lock adapter. This will prevent the Luer Lock adapter from coming loose during use.
  • Twist to remove the syringe cap and then twist to connect the syringe to the vial adapter. Stop twisting when you feel resistance.
  • Inject all the contents of the syringe into the vial. Keep the plunger pressed and gently shake the vial until the powder is completely dissolved. Do not shake.

Gloved hand holding a syringe with the needle facing down, showing pressure with the other hand and an arrow indicating direction

Step3. Withdraw the Reconstituted Vaccine

  • Invert the vial completely and slowly withdraw all the contents into the syringe to obtain a 0.5 ml dose of Abrysvo.
  • Twist to separate the syringe from the vial adapter.
  • Place a suitable sterile needle for intramuscular injection.

The prepared vaccine is a clear and colorless solution. Visually inspect the vaccine for particulate matter and color changes before administration. Do not use if you observe particulate matter or color changes.

For use with the Abrysvo antigen vial (powder) and the solvent vial

The powder must be reconstituted only with the solvent vial provided.

  1. Using a sterile needle and syringe, withdraw all the contents of the solvent vial and inject all the contents of the syringe into the powder vial.
  2. Gently shake the vial with circular movements until the powder is completely dissolved. Do not shake.
  3. Withdraw 0.5 ml from the vial with the reconstituted vaccine.

The prepared vaccine is a clear and colorless solution. Visually inspect the vaccine for particulate matter and color changes before administration. Do not use if you observe particulate matter or color changes.

Disposal

Disposal of the unused product and all materials that have come into contact with it will be carried out in accordance with local regulations.

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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

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Dmytro Horobets

Family medicine 7 years exp.

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Cardiology 18 years exp.

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Allergology 7 years exp.

Dr. Alexander Nazarchuk is a physician specialising in allergology and internal medicine. He provides online consultations for adults, following the principles of evidence-based medicine — no outdated treatments or unnecessary tests, with clear explanations and a personalised approach. He helps patients with a wide range of allergic and therapeutic conditions, from common day-to-day complaints to complex cases involving allergies, gastrointestinal issues, cardiovascular concerns, respiratory symptoms, and more.

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Frequently Asked Questions

Is a prescription required for ABRYSVO powder and solvent for injectable solution?
ABRYSVO powder and solvent for injectable solution requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in ABRYSVO powder and solvent for injectable solution?
The active ingredient in ABRYSVO powder and solvent for injectable solution is respiratory syncytial virus vaccines. This information helps identify medicines with the same composition but different brand names.
Who manufactures ABRYSVO powder and solvent for injectable solution?
ABRYSVO powder and solvent for injectable solution is manufactured by Pfizer Europe Ma Eeig. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of ABRYSVO powder and solvent for injectable solution online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether ABRYSVO powder and solvent for injectable solution is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to ABRYSVO powder and solvent for injectable solution?
Other medicines with the same active substance (respiratory syncytial virus vaccines) include AREXVY powder and suspension for injectable suspension, MRESVIA DISPERSION INJECTABLE IN PRE-FILLED SYRINGE, MVABEA INJECTABLE SUSPENSION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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