Prevenar 20

Package leaflet: Information for the user

Prevenar 20 injectable suspension

20-valent pneumococcal polysaccharide conjugate vaccine (adsorbed)

This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before receiving this vaccine as it contains important information for you.

• Keep this leaflet. 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. Do not give it to other people.
• If you or your child experience any side effect, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

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 aged 6 weeks through to under 18 years of age to help prevent diseases such as meningitis (inflammation of the lining around the brain), sepsis or bacteremia (bacteria in the blood), pneumonia (lung infection), and ear infections (acute otitis media) caused by 20 types of Streptococcus pneumoniae bacteria.*
• Individuals aged 18 years and older to help prevent diseases such as pneumonia (lung infection), sepsis or bacteremia (bacteria in the blood), and meningitis (inflammation of the lining around the brain) caused by 20 types of Streptococcus pneumoniae bacteria.*

Prevenar 20 provides protection against 20 types of Streptococcus pneumoniae bacteria.
The vaccine stimulates the body to produce its own antibodies, which help protect you or your child against these diseases.

2. What you should know before you or the child receives Prevenar 20

Prevenar 20 must not be administered

• if you or the child are allergic (hypersensitive) to the active substances or to any of the other ingredients 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 the child:

• have had or are experiencing health problems after any dose of Prevenar 20, such as an allergic reaction or breathing difficulties,
• have a serious illness or a high fever. A mild fever or a mild upper respiratory tract infection (e.g. a cold) does not in itself justify delaying vaccination,
• have any bleeding disorders or bruise easily,
• have a weakened immune system (e.g. due to human immunodeficiency virus, HIV infection); the maximum benefit from Prevenar 20 may not be achieved.

Talk to your doctor, pharmacist, or nurse before vaccination if the child was born very prematurely (at 28 weeks of gestation or earlier), as longer-than-normal breathing pauses may occur for 2–3 days after vaccination. See also section 4.
As with any vaccine, Prevenar 20 may not protect all vaccinated individuals.
Prevenar 20 will only protect against ear infections caused by the types of Streptococcus pneumoniae included in the vaccine. It will not protect against other infectious agents that may cause ear infections.

Other medicines/vaccines and Prevenar 20
The child may receive Prevenar 20 at the same time as other routine infant vaccines.
In adults, Prevenar 20 can be administered simultaneously with the inactivated influenza vaccine, provided the injections are given at different sites. Depending on the physician's assessment of individual risk, it may be advisable to separate the two vaccinations, e.g. by 4 weeks.
In adults, Prevenar 20 can be administered simultaneously with the mRNA-based COVID-19 vaccine.
Inform your doctor, pharmacist, or nurse if you or the child are taking, have recently taken, or might take any other medicines, or if you have recently received another vaccine.

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

Driving and using machines
Prevenar 20 does not alter or alters negligibly the ability to drive or operate machinery. However, some of the side effects listed in section 4 “Possible side effects” may temporarily affect the ability to drive or operate machinery.

Prevenar 20 contains polysorbate 80
This medicine contains 0.1 mg of polysorbate 80 per dose. Polysorbates may cause allergic reactions. Inform your doctor if you or the child have known allergies.

Prevenar 20 contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially “sodium-free”.

3. How Prevenar 20 is administered

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

Infants aged between 6 weeks and 15 months
The child should receive an initial series of three vaccine injections, followed by a booster dose.

• The first injection may be given as early as 6 to 8 weeks of age.
• Each injection will be given on a separate occasion, with at least 4 weeks between doses, except for the final injection (booster dose), which will be administered between 11 and 15 months of age. You will be informed when the child should return for subsequent injections.

Depending on your country's official recommendations, for further information, please consult your doctor, pharmacist, or nurse.

Premature infants (born before week 37 of gestation)
The child will receive an initial series of three injections followed by a booster dose. The first injection may be given as early as 6 weeks of age, with at least 4 weeks between doses. Between 11 and 15 months of age, the child will receive a fourth injection (booster dose).

Unvaccinated infants aged between 7 months and under 12 months
Infants aged between 7 months and under 12 months should receive three injections. The first two injections should be administered at least 4 weeks apart. A third injection will be given during the second year of life.

Unvaccinated children aged between 12 months and under 24 months
Children aged between 12 months and under 24 months should receive two injections, administered at least 8 weeks apart.

Unvaccinated children aged between 2 years and under 5 years
Children aged between 2 years and under 5 years should receive one injection.

Children aged between 15 months and under 5 years previously fully vaccinated with Prevenar 13
Children aged between 15 months and under 5 years who were previously fully vaccinated with Prevenar 13 should receive one injection.

Children and adolescents aged between 5 years and under 18 years previously fully vaccinated with Prevenar 13
Children and adolescents aged between 5 years and under 18 years who were previously fully vaccinated with Prevenar 13 will receive one injection.
If the child previously received Prevenar 13, an interval of at least 8 weeks must elapse before receiving Prevenar 20.

Adults
Adults should receive a single injection.
Inform your doctor, pharmacist, or nurse if you have previously received a pneumococcal vaccine.

If you have any doubts about the use of Prevenar 20, consult your doctor, pharmacist, or nurse.

Special populations
Individuals considered at higher risk of pneumococcal infection (e.g., 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 haematopoietic stem cell transplantation may receive three injections, the first given 3 to 6 months after transplantation, with at least 4 weeks between doses. A fourth injection (booster dose) is recommended 6 months after the third injection.

4. Possible side effects

Like all vaccines, Prevenar 20 may cause side effects, although not all people experience them.
Serious side effects of Prevenar 20
Inform your doctor immediately if you notice the following serious side effects (see also section 2): swelling of the face, lips, mouth, tongue or throat (edema), difficulty breathing (dyspnea), shortness of breath (bronchospasm); these may be signs of a severe allergic reaction such as anaphylaxis, including shock.
Other side effects
The following side effects include those reported for Prevenar 20 in infants and children (from 6 weeks up to 5 years of age):
Very common: may occur with more than 1 in 10 doses of the vaccine

• Reduced appetite.
• Irritability.
• Drowsiness.
• Fever.
• At the injection site in all children: redness, hardening or swelling, pain or tenderness.
• At the injection site after the booster dose and in children aged between 2 and 5 years: redness, hardening or swelling greater than 2.0–7.0 cm.

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

• Diarrhoea.
• Vomiting.
• Rash.
• Fever (high temperature of 38.9 °C or higher).
• At the injection site after the initial injection series: redness, hardening or swelling greater than 2.0–7.0 cm, pain or tenderness interfering with movement.

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

• Convulsions (or seizures), including those caused by high temperature.
• Hives (or hives-like rash).
• At the injection site: redness, hardening 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 side effects have been observed with Prevenar 13 and may also occur with Prevenar 20:

• Collapse or shock-like state (hypotonic-hyporesponsive episode).
• Allergic reaction (hypersensitivity), including swelling of the face and/or lips.
• Crying.
• Restless sleep.

The following side effects include those reported for Prevenar 20 in children and adolescents (aged between 5 and 18 years):
Very common: may occur with more than 1 in 10 doses of the vaccine

• Headache.
• Muscle pain.
• At the injection site: pain, tenderness, redness, hardening 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 (or hives-like rash).
• Fever.

The following side effects have been observed with Prevenar 13 in post-marketing experience in children and may also occur with Prevenar 20:

• Severe allergic reaction including shock (cardiovascular collapse); swelling of the lips, face or throat (angioedema).
• Swollen lymph nodes or glands (lymphadenopathy) near the vaccination site, such as under the arm or in the groin.
• At the injection site: hives, redness and irritation (dermatitis), and itching sensation (pruritus).
• A skin rash causing itchy red spots (erythema multiforme).

The following side effects are 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

• Diarrhoea, nausea and vomiting.
• Rash and swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing (angioedema).
• Itching at the injection site, swelling of glands in the neck, armpit or groin (lymphadenopathy), hives at the injection site and chills.

The following side effects have been observed with another similar vaccine, Prevenar 13, and may also occur with Prevenar 20:

• A skin rash causing itchy red spots (erythema multiforme).
• Irritation at the injection site.
• Reduced appetite.
• Limited movement of the arm.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store 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 that month.
Store in a refrigerator (2 °C–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 be used or discarded. These data are intended as guidance for healthcare professionals only in the case of temporary temperature excursions.
Pre-filled syringes should be stored horizontally in the refrigerator to minimize the time required for resuspension.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Prevenar 20 contains
The active substances are polysaccharide conjugates with CRM protein (a non-toxic variant of diphtheria toxin), consisting of:

• 2.2 micrograms of polysaccharide for 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 for serotype 6B

One dose (0.5 mL) contains approximately 51 micrograms of CRM carrier protein, adsorbed onto aluminium phosphate (0.125 mg of aluminium).
The other components are sodium chloride, succinic acid, polysorbate 80 and water for injections.

Description of the appearance of Prevenar 20 and contents of the pack
The vaccine is a white injectable suspension supplied in a pre-filled single-dose syringe (0.5 mL).
It is available in packs of 1, 10 and 50, with or without needles. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Brussels
Belgium

Responsible manufacturer for batch release:
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Pfizer NV/SA
Tél/Tel: +32 (0)2 554 62 11

България
Пфайзер Люксембург САРЛ, Клон България
Тел: +359 2 970 4333

Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111

Danmark
Pfizer ApS
Tlf.: +45 44 20 11 00

Deutschland
PFIZER PHARMA GmbH
Tel: +49 (0)30 550055-51000

Eesti
Pfizer Luxembourg SARL Eesti filiaal
Tel: +372 666 7500

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ.: +30 210 6785800

España
Pfizer, S.L.
Télf: +34 91 490 99 00

France
Pfizer Laboratoires
Tél: +33 (0)1 58 07 34 40

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Ireland
Pfizer Healthcare Ireland Unlimited Company
Tel: +1800 633 363 (toll free)
Tel: +44 (0)1304 616161

Ísland
Icepharma hf.
Simi: +354 540 8000

Italia
Pfizer S.r.l.
Tel: +39 06 33 18 21

Κύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Τηλ: +357 22817690

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: +371 670 35 775

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 5 251 4000

Luxembourg/Luxemburg
Pfizer Luxembourg SARL
Tel: +32 (0)2 554 62 11

Magyarország
Pfizer Kft
Tel: +36 1 488 37 00

Malta
Vivian Corporation Ltd.
Tel: +356 21344610

Nederland
Pfizer bv
Tel: +31 (0)800 63 34 636

Norge
Pfizer AS
Tlf: +47 67 52 61 00

Österreich
Pfizer Corporation Austria Ges.m.b.H
Tel: +43 (0)1 521 15-0

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

Portugal
Pfizer, Lda.
Tel: +351 21 423 5500

România
Pfizer Romania S.R.L
Tel: +40 (0) 21 207 28 00

Slovenija
Pfizer Luxembourg SARL, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel.: +386 (0)1 52 11 400

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421 2 3355 5500

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

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

The following information is intended for healthcare professionals only:

During storage, a white deposit and a clear supernatant may be observed. This
is not an indication of deterioration. Prefilled syringes should be stored
horizontally to minimize the resuspension time.
Preparation for administration

Step 1. Vaccine resuspension
Hold the prefilled syringe horizontally between thumb and
index finger and shake vigorously until the contents form a
uniform white suspension. Do not use the vaccine if it cannot
be resuspended.

Step 2. Visual inspection
Visually inspect the vaccine for the presence of large
particulate matter and discoloration prior to administration.
Do not use if any of these are observed. If the vaccine does
not appear as a uniform white suspension, repeat steps 1 and 2.

Step 3. Removal of the syringe tip cap
Remove the syringe tip cap from the Luer Lock adapter by slowly rotating the cap counterclockwise
while holding the Luer Lock adapter.
Note: Take care not to press on the extended plunger during removal of the syringe cap.
For syringes without needle
Step 4. Attachment of a sterile needle
Attach an appropriate needle for intramuscular administration to the prefilled syringe by holding the
Luer Lock adapter and rotating the needle clockwise.
Administer the entire dose.
Prevenar 20 is for intramuscular use only.
Prevenar 20 must not be mixed with other vaccines or medicinal products in the same syringe.
Prevenar 20 may be administered simultaneously with other infant vaccines; in such cases, different
injection sites must be used.
Prevenar 20 may be administered to adults simultaneously with seasonal influenza vaccine (QIV;
surface antigen, inactivated, adjuvanted). In individuals with pre-existing conditions associated with
an increased risk of potentially fatal pneumococcal disease, consideration may be given to separating
the administration of QIV and Prevenar 20 (e.g., by approximately 4 weeks). Different injection sites
must be used.
Prevenar 20 may be administered to adults simultaneously with mRNA-based COVID-19 vaccine
(nucleoside-modified).
Any unused medicinal product and waste material derived from this medicinal product should be
disposed of in accordance with local regulations.