Prevenar 20 injectable suspension in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Prevenar20 injectable suspension

20-valent pneumococcal polysaccharide conjugate vaccine (adsorbed)

This medicinal product is subject to additional monitoring, which will allow quicker identification of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

Read all of this leaflet carefully before receiving this vaccine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed for you or your child only, and must not be given to other people.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Prevenar 20 is 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 side effects
5. How to store Prevenar 20
6. Contents of the pack and other information

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

Prevenar 20 is a pneumococcal vaccine given to:

• Children from 6 weeks to less than 18 years of age to 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 20 types of the bacterium Streptococcus pneumoniae.

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

Prevenar 20 provides protection against 20 types of the bacterium Streptococcus pneumoniae.

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

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

Do not administer Prevenar 20

• if you or your child are allergic (hypersensitive) to the active substances or to any of the other components of this medicine (listed in section 6) or to any other vaccine containing diphtheria toxoid.

Warnings and precautions

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

• Have or have previously had any medical problems after administration of any dose of Prevenar 20, such as an allergic reaction or breathing difficulties.

• Have a serious illness or high fever. However, a mild fever or upper respiratory tract infection (e.g., a cold) in itself is not a reason to delay vaccination.

• Have bleeding disorders or bruise easily.

• Have a weakened immune system (e.g., due to HIV infection); they may not receive the full benefit from Prevenar 20.

Talk to your doctor, pharmacist, or nurse before vaccination if your child was born very prematurely (at 28 weeks of gestation or earlier), as prolonged intervals between breaths may occur during the 2 to 3 days following vaccination.

As with any vaccine, Prevenar 20 may not protect all individuals who are vaccinated.

Prevenar 20 will only protect against ear infections caused by the types of Streptococcus pneumoniae covered by the vaccine. It will not protect against other infectious agents that may cause ear infections.

Other medicines/vaccines and Prevenar 20

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

In adults, Prevenar 20 can be administered simultaneously with the influenza vaccine (inactivated influenza virus) at different injection sites. Depending on the individual risk assessment by your healthcare professional, a separation between the administration of both vaccines—e.g., of 4 weeks—may be recommended.

In adults, Prevenar 20 can be administered simultaneously with the mRNA COVID-19 vaccine.

Inform your doctor, pharmacist, or nurse if you or your child are taking, have recently taken, or might need to take any other medicines, or have recently received any other vaccines.

Pregnancy and breastfeeding

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

Driving and using machines

The effect of Prevenar 20 on the ability to drive and use machines is negligible or none. However, some of the side effects mentioned in section 4 “Possible side effects” may temporarily affect the ability to drive or use machines.

Prevenar 20 contains polysorbate 80

This vaccine contains 0.1 mg of polysorbate 80 per dose. Polysorbates may cause allergic reactions. Inform your doctor if you or your child have any known allergies.

Prevenar 20 contains sodium

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

3. How Prevenar 20 is administered

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

Infants from 6 weeks to 15 months of age

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

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

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

According to official recommendations in your country, consult your doctor, pharmacist, or nurse for further information.

Premature infants (born at less than 37 weeks of gestation)

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

Unvaccinated infants from 7 months to less than 12 months of age

Infants aged 7 months to less than 12 months should receive three injections. The first two injections are given at least 4 weeks apart. A third injection will be administered during the second year of life.

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

Children aged 12 months to less than 24 months should receive two injections, with at least an 8-week interval between them.

Children from 2 years to less than 5 years of age who have not been vaccinated

Children aged 2 years to less than 5 years should receive one injection.

Children from 15 months to less than 5 years of age with prior complete vaccination with Prevenar 13

Children aged 15 months to less than 5 years who have previously completed vaccination with Prevenar 13 will receive one injection.

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

Children and adolescents aged 5 years to less than 18 years will receive one injection.

If your child has previously received Prevenar 13, at least an 8-week interval should elapse before receiving Prevenar 20.

Adults

Adults should receive one injection.

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

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

Special populations

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

Individuals who have undergone hematopoietic stem cell transplantation may receive three injections, the first given between 3 and 6 months after transplantation, with at least a 4-week interval between doses. A fourth injection (booster dose) is recommended 6 months after the third injection.

4. Possible adverse effects

Like all vaccines, Prevenar 20 may cause adverse effects, although not everyone experiences them.

Serious adverse effects of Prevenar 20

Immediately inform your doctor if you notice signs of the following serious 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 serious 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 than 1 in 10 doses of the vaccine

• Decreased appetite
• Irritability
• Feeling sleepy
• Fever
• At the injection site in all children: redness, hardness or swelling, pain or tenderness
• At the injection site after the booster dose and in children aged 2 to less than 5 years: redness, hardness or swelling measuring more than 2.0 to 7.0 cm

Common: may occur with up to 1 in 10 doses of the vaccine

• Diarrhea
• Vomiting
• Rash
• Fever (high temperature of 38.9 °C or higher)
• At the injection site after the primary series of injections: redness, hardness, swelling measuring more than 2.0 to 7.0 cm, pain or tenderness interfering with movement

Uncommon: may occur with up to 1 in 100 doses of the vaccine

• Seizures (or fits), including those caused by high temperature
• Hives (urticaria or urticaria-like rash)
• At the injection site: redness, hardness or swelling greater than 7.0 cm

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

• Allergic reaction (hypersensitivity) at the injection site

The following adverse effects were observed with Prevenar13 and may also be observed with Prevenar 20:

• Collapse or shock-like state (hypotonic-hyporesponsive episode)
• Allergic reaction (hypersensitivity) including 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 than 1 in 10 doses of the vaccine

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

Common: may occur with up to 1 in 10 doses of the vaccine

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

Uncommon: may occur with up to 1 in 100 doses of the vaccine

• Hives (urticaria or urticaria-like rash)
• Fever

The following adverse effects were observed with Prevenar13 and may also be observed with Prevenar 20:

• Diarrhea
• Vomiting
• Decreased appetite
• Irritability
• Feeling sleepy
• 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 interfering with movement, were very common.

The following adverse effects were observed with Prevenar13 in post-marketing experience in children and may also be observed with Prevenar 20:

• Severe allergic reaction including shock (cardiovascular collapse); swelling of lips, face or throat (angioedema)
• Enlarged glands or lymph nodes (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 causing itchy red spots (erythema multiforme)

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

Very common: may occur with more than 1 in 10 doses of the vaccine

• Headache
• Joint pain and muscle pain
• Pain/tenderness at the injection site and fatigue

Common: may occur with up to 1 in 10 doses of the vaccine

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

Uncommon: may occur with up to 1 in 100 doses 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, swelling of lymph nodes in the neck, armpits or groin (lymphadenopathy), hives at the injection site (urticaria), and chills

The following adverse effects were observed with Prevenar13 and may also be observed with Prevenar 20:

• A rash causing itchy red spots (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, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system listed in Appendix V.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Prevenar 20

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

Do not use this medicine after the expiry date stated on the carton and label after “EXP”. The expiry date refers to the last day of the month indicated.

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

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

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

Stability data indicate that the vaccine is stable for 96 hours when stored at temperatures between 8 °C and 25 °C, or for 72 hours when stored at temperatures between 0 °C and 2 °C. After these time periods, Prevenar 20 must either be used or discarded. These data are intended to guide healthcare professionals in the event of temporary temperature excursions only.

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

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Prevenar20

The active substances are polysaccharides conjugated to CRM197 consisting of:

• 2.2 micrograms of polysaccharide from 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 from serotype 6B.

One dose (0.5 ml) contains approximately 51 micrograms of carrier protein CRM197, adsorbed onto aluminium phosphate (0.125 mg of aluminium).

The other components are sodium chloride, succinic acid, polysorbate 80 and water for injections.

Appearance of Prevenar20 and contents of the pack

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

Marketing Authorisation Holder and Manufacturer

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

Date of the most recent review of this summary: <{MM/YYYY}>.

Other sources of information

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.euopa.eu.

This information is intended for healthcare professionals only:

During storage, a white sediment and a clear supernatant may be observed. This does not indicate deterioration. Pre-filled syringes should be stored in a horizontal position to minimize resuspension time.

Preparation for administration

Step 4. Attach a sterile needle

Attach an appropriate needle for intramuscular administration to the prefilled syringe by holding the Luer lock adapter and turning the needle clockwise.

Administer the complete dose.

Prevenar 20 is administered only by the intramuscular route.

Prevenar 20 must not be mixed with other vaccines or medications in the same syringe.

Prevenar 20 may be administered at the same time as other pediatric vaccines; in this case, different injection sites must be used.

Prevenar 20 may be administered to adults simultaneously with seasonal influenza vaccine (QIV; inactivated surface antigen, adjuvanted). In individuals with underlying conditions associated with a high risk of potentially life-threatening pneumococcal disease, administration of QIV and Prevenar 20 may be separated (e.g., approximately 4 weeks apart). Different injection sites should be used.

Prevenar 20 may be administered to adults at the same time as the mRNA COVID-19 vaccine (with modified nucleosides).

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