Arexvy polvo y suspension para suspension inyectable

Prospect: information for the user

Arexvy powder and suspension for injectable suspension

Respiratory syncytial virus vaccine (recombinant, adjuvanted)

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

• Keep this prospectus, as you may need to refer to it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to other people.
• If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Arexvy is a vaccine that helps protect adults aged 60 years and olderfrom a virus called the “respiratory syncytial virus” (RSV).

Arexvy also helps protect against RSV in adults aged 50 to 59 years with a higher risk of contracting the disease caused by RSV.

RSV is a respiratory virus that spreads very easily.

• RSV can cause lower respiratory tract disease - infections in the lungs and other parts of the body that help you breathe.

RSV infection typically produces mild symptoms similar to those of a cold in healthy adults. However, it can also:

• produce more severe respiratory diseases and complications, such as pneumonia,in older adultsand in adults with underlying conditions
• exacerbate some diseases, such as respiratory or cardiac diseases

in the long term.

How Arexvy works

Arexvy helps your body's natural defenses generate special antibodies and white blood cells. These protect you against RSV.

Arexvy does not contain the virus. This means it cannot cause an infection.

Do not use Arexvy

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

Do not use Arexvy if any of the above applies to you. If you are unsure, consult your doctor or pharmacist.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting Arexvy if:

• you have ever had a severe allergic reaction after an injection of any other vaccine
• you have a severe infection with high temperature (fever). If this happens, the vaccination may be delayed until you feel better. A minor infection, such as a cold, should not be a problem, but consult your doctor first
• you have a bleeding disorder or bruise easily
• you fainted after a previous injection. Fainting can occur before or after any injection with a needle.

If any of the above applies to you, or if you are unsure, consult your doctor or pharmacist before Arexvy is administered to you.

As with all vaccines, Arexvy may not protect all vaccinated individuals completely.

Other medicines/vaccines and Arexvy

Inform your doctor or pharmacist if:

• you are taking, have taken recently, or may need to take any other medicine. This includes medicines obtained without a prescription
• you have received recently any other vaccine.

Arexvy can be administered at the same time as a flu vaccine.

If Arexvy is administered at the same time as another injectable vaccine, a different injection site will be used for each vaccine, i.e., a different arm for each injection.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before this vaccine is administered to you. Arexvy is not recommended during pregnancy or breastfeeding.

Driving and operating machinery

Some of the effects mentioned in section 4 “Possible side effects” (e.g., feeling tired) may temporarily affect your ability to drive or use machines. Do not drive or use machines if you do not feel well.

Arexvy contains sodium and potassium

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

This medicine contains potassium, less than 1 mmol (39 mg) per dose; this is essentially “potassium-free”.

Arexvy is administered via a single dose injection of 0.5 ml into a muscle. It is typically administered in the upper arm.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

The following adverse effects may occur after receiving Arexvy:

Very Frequent(may occur in more than 1 in 10 vaccine doses):

• Pain at the injection site
• Fatigue (fatigue)
• Headache
• Muscle pain (myalgia)
• Joint pain (arthralgia)
• Redness at the injection site

Frequent(may occur in up to 1 in 10 vaccine doses):

• Swelling at the injection site
• Fever
• Chills

Infrequent(may occur in up to 1 in 100 vaccine doses):

• Itching at the injection site
• Pain
• General discomfort
• Enlargement of lymph nodes, or swelling of lymph nodes in the neck, armpits, or groin (lymphadenopathy)
• Allergic reactions, such as rash
• Nausea
• Vomiting
• Stomach pain

Inform your doctor or pharmacist if you experience any of the adverse effects mentioned above. The intensity of most of these adverse effects is mild to moderate and do not last long.

If you experience any severe adverse effects or any adverse effects not mentioned in this prospectus, inform your doctor or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through thenational notification system included in theAppendix V. By reporting adverse 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 label and the box, after CAD. The expiration date is the last day of the month indicated.
• Store in refrigerator (between 2 °C and 8 °C).
• Do not freeze.
• Store in the original packaging to protect it from light.
• Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Arexvy

• The active principles are:

After reconstitution, a dose (0.5 ml) contains:

1glicoprotein F recombinant from the respiratory syncytial virus stabilized in the prefusion conformation = VRSPreF3

2VRSPreF3 produced in Chinese hamster ovary cells (OHC) using recombinant DNA technology

VRSPreF3 is a protein from the respiratory syncytial virus. This protein is not infectious.

The adjuvant is used to improve the body's response to the vaccine.

• The other components are:

• Dry powder(VRSPreF3 antigen): trehalose dihydrate, polysorbate 80 (E 433), potassium dihydrogen phosphate (E 340) and dipotassium phosphate (E 340).
• Liquid suspension: dioleoyl phosphatidylcholine (E 322), cholesterol, sodium chloride, anhydrous disodium phosphate (E 339), potassium dihydrogen phosphate (E 340) and water for injection.

See section 2 “Arexvy contains sodium and potassium”.

Appearance of the product and contents of the pack

• Dry powder and liquid suspension for injection.
• The dry powder is white.
• The liquid suspension is an opalescent, colourless to light brown liquid.

A pack of Arexvy consists of:

• Dry powder (antigen) for 1 dose in a vial
• Liquid suspension (adjuvant) for 1 dose in a vial

Arexvy is available in packs of 1 vial with dry powder and 1 vial with liquid suspension or in packs of 10 vials with dry powder and 10 vials with liquid suspension.

Only some pack sizes may be marketed.

Marketing authorization holder and responsible person

GlaxoSmithKline Biologicals SA

Rue de l’Institut 89

1330 Rixensart

Belgium

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu,and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/).

This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

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This information is intended for healthcare professionals only:

Arexvy is presented as a green mustard-coloured vial with a removable cap containing the dry powder (antigen) and a brown-coloured vial with a removable cap containing the liquid suspension (adjuvant).

The dry powder and liquid suspension must be reconstituted before administration.

The dry powder and liquid suspension must be visually inspected to observe any foreign particles and/or changes in appearance. If any of these circumstances are observed, the vaccine must not be reconstituted.

How to prepare Arexvy

Arexvy must be reconstituted before administration.

1. Remove all the contents of the vial containing the liquid suspension with a syringe.

2. Add all the contents of the syringe to the vial containing the dry powder.

3. Gently agitate until the dry powder is completely dissolved.

The reconstituted vaccine is an opalescent, colourless to light brown liquid.

The reconstituted vaccine must be visually inspected to observe any foreign particles and/or changes in appearance. If any of these circumstances are observed, the vaccine must not be administered.

The physical and chemical stability has been demonstrated in use for 4 hours between 2 °C and 8 °C or at room temperature up to 25 °C.

From a microbiological point of view, the vaccine must be used immediately. If not used immediately, the times and conditions of storage in use before use are the responsibility of the user and must not exceed 4 hours.

Before administration

1. Remove 0.5 ml of the reconstituted vaccine with a syringe.

2. Change the needle so that a new needle is used.

Administer the vaccine by intramuscular injection.

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