Prevenar 20 suspension inyectable en jeringa precargada

Prospect: information for the user

Prevenar 20 injectable suspension

Conjugated pneumococcal polysaccharide vaccine (20-valent, adsorbed)

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 receiving this vaccine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This vaccine has been prescribed only for you or your child, and it should not be given to other people.
• If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus. See section4.

1.What is Prevenar 20 and what it is used for

2.What you need to know before you or your child receive Prevenar 20

3.How Prevenar 20 is administered

4.Possible adverse effects

5.Storage of Prevenar 20

6.Contents of the package and additional information

Prevenar 20 is a pneumococcal conjugate vaccine administered to:

• Children from 6 weeks to less than 18 years of ageto help prevent diseases such as: meningitis (inflammation around the brain), sepsis or bacteremia (bacteria in the bloodstream), pneumonia (lung infection) and ear infections (acute otitis media) caused by 20types of the bacteriaStreptococcus pneumoniae.

• Individuals 18 years of age and olderto help prevent diseases such as: pneumonia (lung infection), sepsis or bacteremia (bacteria in the bloodstream) and meningitis (inflammation around the brain) caused by 20types of the bacteriaStreptococcus pneumoniae.

Prevenar 20 provides protection against 20types of the bacteriaStreptococcus pneumoniae.

The vaccine works by helping the body to produce its own antibodies, which protect you or your child against these diseases.

Do not administer Prevenar 20

•if you or your child are allergic (hypersensitive) to the active ingredients or to any of the other components of this medication (listed in section6) or to any other vaccine that contains diphtheria toxoid.

Warnings and precautions

Consult your doctor, pharmacist or nurse before vaccination if you or your child:

• Have or have had in the past any medical problem after administration of any dose of Prevenar 20 as an allergic reaction or breathing problems.
• Have a serious illness or high fever. However, a mild fever or an upper respiratory tract infection (for example, a cold) in itself is not a reason to delay vaccination.
• Have bleeding problems or bruise easily.

• Have a weakened immune system (for example, due to HIV infection); it is possible that you will not get the full benefit of Prevenar 20.

Consult your doctor, pharmacist or nurse before vaccination if your child was born prematurely (at 28weeks of gestation or earlier), as prolonged intervals between breaths may occur for 2 or 3days after vaccination.

As with any vaccine, Prevenar 20 will not protect all vaccinated individuals.

Prevenar 20 will only protect against ear infections caused by the types ofStreptococcus pneumoniaefor which the vaccine has been developed. It will not protect against other infectious agents that may cause ear infections.

Other medications/vaccines and Prevenar 20

Your child may receive Prevenar 20 at the same time as other pediatric vaccines on the schedule.

In adults, Prevenar 20 may be administered at the same time as the flu vaccine (inactivated influenza virus) in different injection sites. According to individual risk assessment by your healthcare professional, a separation of, forexample, 4weeks between administration of both vaccines may be recommended.

In adults, Prevenar 20 may be administered at the same time as the COVID‑19 mRNA vaccine.

Inform your doctor, pharmacist or nurse if you or your child are taking, have taken recently or may need to take any other medication, or have received recently any other vaccine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before receiving this vaccine.

Driving and operating machinery

The influence of Prevenar 20 on the ability to drive and operate machinery is negligible or insignificant. However, some of the effects mentioned in section4 “Possible adverse effects” may temporarily affect the ability to drive or operate machinery.

Prevenar 20 contains sodium

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

The doctor or nurse will administer the recommended dose (0.5ml) of the vaccine to your child's arm or thigh muscle.

Infants from 6weeks to 15months of age

Your child must receive an initial series of three injections of the vaccine followed by a booster dose.

• The first injection can be administered from 6weeks to 8weeks of age.
• Each injection will be administered separately with an interval of at least 4 weeks between doses, except for the last injection (booster dose), which will be administered between 11 and 15months of age.

You will be informed when your child should return for the next injections.

According to the official recommendations of your country, consult your doctor, pharmacist, or nurse for more information.

Preterm infants (born before 37weeks of gestation)

Your child will receive an initial series of three injections followed by a booster dose. The first injection can be administered at 6weeks of age with an interval of at least 4 weeks between doses. Between 11 and 15months of age, your child will receive a fourth injection (booster dose).

Infants from 7months to less than 12 months of age who are not vaccinated

Infants from7 months to less than 12monthsof age must receive three injections. The first two are administered with an interval of at least 4weeks apart. A third injection will be given in the second year of life.

Children from 12months to less than 24 months of age who are not vaccinated

Children from12 months to less than 24monthsof age must receive two injections, with an interval of at least 8weeks apart.

Children from2 years to less than 5years of age who are not vaccinated

Children from2 years to less than 5yearsof age must receive one injection.

Children from 15 months to less than 5 years of age who have completed previous vaccination with Prevenar 13

Children from15months to less than 5yearsof age who have completed previous vaccination with Prevenar13 will receive one injection.

Children and adolescents from 5 years to less than 18 years of age, regardless of previous vaccination with Prevenar 13

Children and adolescents from5 years to less than 18yearsof age will receive one injection.

If your child has received Prevenar13 previously, there must be an interval of at least 8weeks before receiving Prevenar 20.

Adults

Adults must receive one injection.

Inform your doctor, pharmacist, or nurse if you have been administered a pneumococcal vaccine previously.

If you have any other questions about the use of Prevenar 20, ask your doctor, pharmacist, or nurse.

Special populations

People with a higher risk of pneumococcal infection (such as those with sickle cell disease or HIV infection), including those who have been previously vaccinated with the pneumococcal polysaccharide 23‑valent vaccine, may receive at least one dose of Prevenar 20.

People who have undergone hematopoietic stem cell transplantation may receive three injections, the first between3 and 6months after transplantation and with an interval of at least 4weeks between doses. A fourth injection (booster dose) is recommended 6months after the third injection.

Like all vaccines, Prevenar 20 may cause adverse effects, although not all people may experience them.

Severe adverse effects of Prevenar 20

Inform your doctor immediately if you notice signs of the following severe adverse effects (see also section 2): swelling of the face, lips, mouth, tongue, or throat (edema), difficulty breathing (dyspnea), wheezing (bronchospasm) - these may be signs of a severe allergic reaction such as anaphylaxis, including anaphylactic shock.

Other adverse effects

The following adverse effects include those reported for Prevenar 20 in infants and children (6 weeks to less than 5 years of age):

Very common:may occur with more than1 in 10doses of the vaccine

• Decreased appetite
• Irritability
• Sensation of sleepiness
• Fever
• At the injection site for all children: redness, hardness, or swelling, pain, or tenderness
• At the injection site after the booster dose and in children 2 to less than 5 years of age: redness, hardness, or swelling of more than2.0 to 7.0cm

Common:may occur with up to1 in 10doses of the vaccine

• Diarrhea
• Vomiting
• Rash
• Fever (temperature of 38.9°C or higher)
• At the injection site after the initial series of injections: redness, hardness, swelling of more than2.0 to 7.0cm, pain, or tenderness that interferes with movement.

Uncommon:may occur with up to1 in 100doses of the vaccine

• Convulsions (or seizures), including those caused by a high temperature
• Hives (urticaria or rash similar to urticaria)
• At the injection site: redness, hardness, or swelling of more than 7.0cm

Rare:may occur with up to1 in 1,000doses of the vaccine

• Allergic reaction (hypersensitivity) at the injection site

The following adverse effects were observed with Prevenar 13 and may also be observed with Prevenar 20:

• Collapse or state similar toshock(hypotonic-hyporeactive episode)
• Allergic reaction (hypersensitivity) that includes swelling of the face or lips
• Crying
• Restless sleep

The following adverse effects include those reported for Prevenar 20 in children and adolescents (5 years to less than 18 years of age):

Very common:may occur with more than1 in 10doses of the vaccine

• Headache
• Muscle pain
• At the injection site: pain, tenderness, redness, hardness, or swelling
• Tiredness

Common:may occur with up to1 in 10doses of the vaccine

• Joint pain
• At the injection site: pain or tenderness that interferes with movement

Uncommon:may occur with up to1 in 100doses of the vaccine

• Hives (urticaria or rash similar to urticaria)
• Fever

The following adverse effects were observed with Prevenar 13 and may also be observed with Prevenar 20:

• Diarrhea
• Vomiting
• Decreased appetite
• Irritability
• Sensation of sleepiness
• Restless sleep
• Rash

Children and adolescents with HIV infection, sickle cell disease, or hematopoietic stem cell transplant had similar adverse effects; however, the frequencies of vomiting, diarrhea, fever, joint pain, and at the injection site: pain or tenderness that interferes with movement, were very common.

The following adverse effects were observed with Prevenar 13 in the post-marketing experience in children and may also be observed with Prevenar 20:

• Severe allergic reaction includingshock(cardiovascular collapse); swelling of the lips, face, or throat (angioedema)
• Enlarged lymph nodes or lymphadenopathy near the vaccination site, such as under the arm or in the groin
• At the injection site: hives (urticaria), redness, and irritation (dermatitis) and itching (pruritus)
• A rash that produces red, itchy patches (erythema multiforme)

The following adverse effects include those reported for Prevenar 20 in adults:

Very common:may occur with more than1 in 10doses of the vaccine

• Headache
• Joint and muscle pain
• Pain or tenderness at the injection site and tiredness

Common:may occur with up to1 in 10doses of the vaccine

• Swelling at the injection site, redness at the injection site, and fever

Uncommon:may occur with up to1 in 100doses of the vaccine

• Diarrhea, nausea, and vomiting
• Rash and swelling of the face, lips, mouth, tongue, or throat that may cause difficulty swallowing or breathing (angioedema)
• Itching at the injection site, inflammation of the lymph nodes in the neck, armpits, or groin (lymphadenopathy), hives at the injection site (urticaria), and chills

The following adverse effects were observed with Prevenar 13 and may also be observed with Prevenar 20:

• A rash that produces red, itchy patches (erythema multiforme)
• Irritation at the injection site
• Decreased appetite
• Limitation of arm movement

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products for Human Use:www.notificaRAM.es. 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 box and label after “EXP.” The expiration date is the last day of the month indicated.

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

Prevenar 20 should be used as soon as possible after removing it from the refrigerator.

Do not freeze. Discard if the vaccine has frozen.

The stability data indicate that the vaccine is stable for 96hours when stored at temperatures of 8°C to 25°C or 72hours when stored at temperatures of 0°C to 2°C. At the end of these periods of time,Prevenar 20should be used or discarded.These data are intended to guide healthcare professionals in the event of temporary temperature variations only.

Pre-filled syringes should be stored in a horizontal position to minimize resuspension time.

Medicines should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of empty containers and unused medications. This will help protect the environment.

Composition of Prevenar 20

The active principles are conjugated polysaccharides with CRM 197 that consist of:

• 2.2 micrograms of polysaccharide of serotypes 1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F.
• 4.4 micrograms of polysaccharide of serotype 6B.

A dose (0.5 ml) contains approximately 51 micrograms of CRM 197 protein carrier, adsorbed on aluminium phosphate (0.125 mg of aluminium).

The other components are sodium chloride, succinic acid, polisorbate 80, and water for injection.

Appearance of Prevenar 20 and contents of the pack

The vaccine is a white injectable suspension presented in a pre-filled syringe of single dose (0.5 ml). It is presented in packs of 1, 10, and 50, with or without needles. Only some pack sizes may be marketed.

Marketing authorisation holder and responsible person for the batch release

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country.

Last update of this leaflet: 01/2025.

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.

This information is intended for healthcare professionals only:

During storage, it is possible to observe a white sediment and a transparent supernatant. This does not constitute a sign of deterioration. Pre-filled syringes should be stored in a horizontal position to minimize the time of resuspension.

Preparation for administration

Step 4. Place a sterile needle

Place a suitable needle for intramuscular administration in the pre-filled syringe, holding the Luer lock adapter and turning the needle in the direction of the clock. Administer the full dose. Prevenar 20 is only administered by intramuscular route. Prevenar 20 should not be mixed with other vaccines or medications in the same syringe. Prevenar 20 can be administered at the same time as other pediatric vaccines; in this case, different injection sites should be used. Prevenar 20 can be administered to adults at the same time as the seasonal influenza vaccine (QIV; surface antigen, inactivated, with adjuvant). In subjects with underlying conditions associated with a high risk of developing potentially fatal pneumococcal disease, it may be considered to separate the administrations of QIV and Prevenar 20 (e.g., approximately 4 weeks). Different injection sites should be used. Prevenar 20 can be administered to adults at the same time as the mRNA vaccine against COVID-19 (with nucleoside modifications).

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