InfoCons Consumer Protection informs you – Vaxneuvance – Package Leaflet

Before anything else

Read all of this leaflet carefully before you or your child is vaccinated 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.
• This vaccine has been prescribed for you or your child only. Do not pass it on to others.
• If you get any side e ffects, talk to your doctor, pharmacist , or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

ℹ️ 1. What Vaxneuvance is and what it is used for

Vaxneuvan ce is a pneumococcal vaccine given to:

• children from 6 weeks to less than 18 years of age to help protect against diseases such as lung infection (pneumonia), inflammation of the coverings of the brain and spinal cord (meningitis), a severe infection in the blood (bacteraemia) and ear infections (acute otitis media) ,
• individuals 18 years of age and older to help protect against diseases such as lung infection (pneumonia), inflammation of the coverings of the brain and spinal cord (meningitis) and a severe infection in the blood (bacteraemia), caused by 15 types of bacteria called Streptococcus pneumoniae or pneumococcus.

⚠️ 2. What you need to know before you or your child receive s Vaxneuvance

Do not receive Vaxneuvance if:

• you or your child is allergic to the active substances or to any of the ingredients of this vaccine

(listed in section 6), or to any vaccine that contains diphtheria toxoid.

Warnings and precautions

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

• the immune system is weak (which means the body is less able to fight off infections) or if you or your child is taking certain medicines that may make the immune system weak (for example, immunosuppressants or steroids).
• you or your child has a high fever or severe infection. In these cases, the vaccination may have to be postponed until you or your child has recovered. However, a mild fever or infection (for example having a cold) itself is not a reason to delay vaccination.
• you or your child has any bleeding problems, bruise s easily, or is taking medicines to prevent blood clots.

If your child is an infant, also tell your doctor if your child was born prematurely (too early ).

As with any vaccine , Vaxneuvance may not fully protect all persons who are vaccinated .

37Other medicines/vaccines and Vaxneuvance Your child can be given Vaxneuvance at the same time as other routine childhood vaccines.

In adults, Vaxneuvance can be given at the same time as the flu (inactivated influenza) vaccine.

Tell your doctor, pharmacist, or nurse if:

• you or your child is taking, has recently taken, or might take any prescription medicines (for example, immunosuppressants or steroids which may make the immune system weak) or any medicines obtained without a prescription.
• you or your child has recently received or plan to receive any other vaccine.

Pregn ancy and breast -feeding If you are pregnant or breast -feeding, think you may be pregnant or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before you receive this vaccine.

Driving and using machines

Vaxneuvance has no or negligible influence on the ability to drive and use mac hines. However, some of the effects mentioned under section 4 “Possible side effects” may temporarily affect the ability to drive or use machines.

Vaxneuvance contains sodium and polysorba te 20

This medicin e contains less than 1 mmol sodium (23 milligrams ) per dose, that is to say essentially ‘sodium -free’.

This medicine contains 1 mg of polysorbate 20 in each 0.5 mL dose . Polysorbates may cause allergic reactions. Tell your doctor if you or your child ha s any known allergies.

💊 3. How Vaxneuvance is given

Tell your doctor, pharmacist, or nurse if you or your child has been given a pneumococcal vaccine before.

Your doctor or nurse will give the vaccine into your arm muscle or into your child’s arm or leg muscle.

Infants and children aged 6 weeks to less than 2 years Your child should receive an initial course of 2 injections of the vaccine followed by a booster dose.

• The first injection may be given as early as 6 weeks of age.
• A second injection is administered 2 months later .
• A third injection (booster) will be given between 11 through 15 months of age.

You will be told when your child should come back for each injection.

According to official recommendations in your coun try, an alternative schedule of 3 injections followed by a booster dose may be used by your healthcare provider. Please speak to your doctor, pharmacist, or nurse for more information.

Premature infants ( born earlier than 37 weeks of pregnancy) Your child should receive an initial course of 3 injections of the vaccine followed by a booster dose .

• The first injection may be given as early as 6 weeks of age .
• The second and third injections are given thereafter with an interval of 4 to 8 weeks between doses.
• A fourth injection (booster) will be given between 11 through 15 months of age.

Infants, children and adolescents starting the vaccination at 7 months of age or older Infants 7 to less than 12 months of age should receive a total of 3 injections. The first two injections will be given at least 1 month apart. The third injection (booster) will be given after 12 months of age and at least 2 months after the second injection.

38Children 12 months to less than 2 years of age should receive a total of 2 injections. The two injections will be given at least 2 months apart.

Children and adolescents 2 to less than 18 years of age should receive 1 in jection.

Adults Adults should receive 1 injection.

Special populations One or more injection s of Vaxneuvance may be given to individuals who have one or more underlying conditions that increase their risk for pneumococcal disease (such as individuals with sickle cell disease or living with human immunodeficiency virus [ HIV] or recipients of a stem cell transplan t).

If you have any further questions on the use of Vaxneuvance , ask your doctor, pharmacist, or nurse.

❗ 4. Possible side effects

Like all vaccines , Vaxneuvance can cause side effects, although not everybody gets them.

Serious side effects

Get medical care right away if you or your child has symptoms of an allergic reaction, which may include:

• Wheezing or trouble breathing
• Swelling of the face, lips, or tongue
• Hives
• Rash

Other side effects

The following side effects can be seen after the use of Vaxneuvance in infants, children and adolescents:

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

• Decreased appetite (in those 6 weeks to less than 2 years of age)
• Irritability (in those 6 weeks to less than 2 years of age)
• Drowsiness (in those 6 weeks to less than 2 years of age)
• Headache (in those 2 to less than 18 years of age)
• Muscle aches (in those 2 to less than 18 years of age)
• Fever (temperature of 38 °C or higher in those 6 weeks to less than 2 years of age )
• Pain, redness or swelling at the injection site
• Hardness at the injection site (in those 6 weeks to less than 2 years of age )
• Feeling tired (in those 2 to less than 18 years of age )

Common (may affect up to 1 in 10 people)

• Decreased appetite (in those 2 to less than 18 years of age)
• Irritability (in those 2 to less than 18 years of age)
• Drowsiness (in those 2 to less than 18 years of age)
• Nausea (in those 2 to less than 18 years of age)
• Vomiting (in those 6 weeks to less than 2 years of age)
• Hives
• Rash (in those 6 weeks to less than 2 years of age)
• Fever (temperature of 38 °C or higher in those 2 to less than 18 years of age)
• Hardness at the injection site (in those 2 to less than 18 years of age)
• Bruising at the injection site 39Uncommon (may affect up to 1 in 100 people):
• Vomiting (in those 2 to less than 18 years of age)
• Hives at the injection site (in those 6 weeks to less than 2 years of age)

Not known (cannot be estimated from the available data)

• Rash (in those 2 to less than 18 years of age) The following side effects can be seen after the use of Vaxneuvance in adults:

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

• Headaches
• Muscle aches
• Joint pain (in those 18 to 49 years of age)
• Pain, swelling , or redness at the injection site
• Feeling tired

Common (may affect up to 1 in 10 people)

• Dizziness (in those 18 to 49 years of age)
• Nausea (in those 18 to 49 years of age)
• Joint pain (in those 50 years of age and older)
• Fever (in those 18 to 49 years of age)
• Itchiness at the injection site
• Chills (in those 18 to 49 years of age)

Uncommon (may affect up to 1 in 100 people)

• Dizziness (in those 50 years of age and older)
• Nausea (in those 50 years of age and older)
• Vomiting
• Rash
• Fever (in those 50 years of age and older)
• Warmth at the injection site
• Bruising at the injection site
• Chills (in those 50 years of age and older)

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

• Allergic reaction such as hives, tongue swelling, flushing, and throat tightness These side effects are generally mild and last a short time .

Reporting of side effects

If you or your child gets any side effects, talk to your doctor, pharmacist , or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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. How to store Vaxneuvance

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

Do not use this vaccine after the expiry date which is stated on the carton and syringe label after EXP.

The expiry date refers to the last day of that month.

Store in a refrigerator ( 2 C – 8 C). Do not freeze. Keep the pre -filled sy ringe in the outer carton in order to protect from light.

40Vaxneuvance should be administered as soon as possible after being removed from the refrigerator.

However, in circumstances where Vaxneuvance is temporarily held outside of refrigeration, the vaccine is stable at temperatures up to 25 C for 48 hours. If this period is exceeded, the vaccine should be discarded.

📦 6. Contents of the pack and other information

What Vaxneuvance contains

The active substances are:

• bacterial sugar s from pneumococ cus types 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F (2.0 micrograms of each type) ;
• bacterial sugar from pneumococc us type 6B (4.0 micrograms) .

Each bacterial sugar is linked to a carrier protein (CRM 197). The bacterial sugars and the carrier protein are not alive and do not cause disease.

One dose (0.5 mL) contains approximately 30 micrograms carrier protein, adsorbed on aluminium phosphate (125 micro grams aluminium [Al3+]). Aluminium phosphate is included in the vaccine as an adjuvant. Adjuvants are included to improve the immune responses of vaccines.

The other ingredients are sodium chlori de (NaCl) , L-histidine, polysorbate 20, and water for injections.

What Vaxneuvance looks like and contents of the pack

Vaxneuvance is an opalescent suspension for injection, provided in a single -dose, pre -filled syringe (0.5 mL). Vaxneuvance is available in pack sizes of 1 or 10, either without needles , with 1 needle, or with 2 needles .

Vaxneuvance is also available in multipacks comprising 5 cartons, each containing 10 pre -filled syringes without needles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39 2031 BN Haarlem The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België /Belgique/Belgien MSD Belgium Tél/Tel: +32(0)27766211 dpoc_belux@ msd.comLietuva UAB Merck Sharp & Dohme Tel. +370 5 2780 247 [email protected] България Мерк Шарп и Доум България ЕООД тел.: +359 2 819 3737 info-msdbg@ msd.comLuxembourg/Luxemburg MSD Belgium Tél/Tel: +32(0)27766211 dpoc_belux@ msd.com Česká republika Merck Sharp & Dohme s.r.o.

Tel.: +420 277 050 000 dpoc_czechslovak@ msd.comMagyarország MSD Pharma Hungary Kft.

Tel.: +36 1 888 5300 hungary_msd@ msd.com Danmark MSD Danmark ApS Tlf.: +45 4482 4000 dkmail@ msd.comMalta Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) [email protected] Deutschland MSD S harp & Dohme GmbH Tel.: +49 (0) 89 20 300 4500 [email protected] Merck Sharp & Dohme B.V.

Tel: 0800 9999000 (+31 23 5153153) medicalinfo.nl@ msd.com Eesti Merck Sharp & Dohme OÜ Tel: +372 614 4200 [email protected] MSD (Norge) AS Tlf : +47 32 20 73 00 [email protected] Ελλάδα MSD Α.Φ.Ε.Ε.

Τηλ: +30 210 98 97 300 dpoc.greece@ msd.comÖsterreich Merck Sharp & Dohme Ges.m.b.H.

Tel: +43 (0) 1 26 044 dpoc_austria@ msd.com España Merck Sharp & Dohme de España, S.A.

Tel: +34 91 321 06 00 msd_info@ msd.comPolska MSD Polska Sp. z o.o.

Tel.: +48 22 549 51 00 msdpolska@ msd.com France MSD France Tél: +33 (0)1 80 46 40 40Portugal Merck Sharp & Dohme, Lda Tel.: +351 21 4465700 inform_pt@ msd.com Hrvatska Merck Sharp & Dohme d.o.o.

Tel: +385 1 6611 333 [email protected]ânia Merck Sharp & Dohme Romania S.R.L .

Tel.: +40 21 529 29 00 msdromania@ msd.com Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700 medinfo_ireland@ msd.comSlovenija Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: +386 1 520 4201 msd.slovenia@ msd.com Ísland Vistor ehf.

Sími: +354 535 7000Slovenská republika Merck Sharp & Dohme, s. r. o .

Tel.: +421 2 58282010 dpoc_czechslovak@ msd.com Italia MSD Italia S.r.l.

Tel: 800 23 99 89 (+39 06 361911 ) dpoc.italy @msd.comSuomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 650 [email protected] 42Κύπρος Merck Sharp & Dohme Cyprus Limited Τηλ: 800 00 673 (+357 22866700) [email protected] Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@ msd.com Latvija SIA Merck Sharp & Dohme Latvija Tel.: +371 67025300 [email protected] This leaflet was last revised in .

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu. <———————————————————————————————————————— >

🩺 Information intended for healthcare professionals only

Vaxneuvance must not be injected intravascularly.

• Vaxneuv ance may appear as a clear liquid with a precipitate before shaking.
• Immediately before use and prior to attaching the needle and expelling air from the syringe, hold the pre -filled syringe horizontally and shake vigorously to obtain an opalescent suspensi on.

Multiple attempts may be required to achieve complete resuspension. Do not use the vaccine if it cannot be resuspended.

• Inspect the suspension visually for particulate matter and discolo uration prior to administration.

Discard the vaccine if particulates are present after vigorous shaking and/or if it appears discoloured.

• Attach a needle with Luer lock connection by twisting in a clockwise direction until the needle fits securely on the sy ringe.
• Inject immediately using the intramuscular route, preferably in the anterolateral aspect of the thigh in infants or in the deltoid area of the upper arm in children and adults.
• Exercise care to avoid harm from an accidental needle stick.

Vaxneuvance must not be mixed with any other vaccines in the same syringe.

Vaxneuvance can be given concomitantly with other routine childhood vaccine s.

Vaxneuvance can be administered concomitantly with seasonal quadrivalent influenza vaccine (split virion, inactivated) in adults .

Different injectable vaccines should always be administered at different injection sites.

Store in a refrigerator (2 ℃– 8 ℃). Do not freeze.

Keep the pre -filled syringe in the outer carton in order to protect from light.

Vaxneuvance should be administered as soon as possible after being removed from the refrigerator.

43In the event of temporary temperature excursions, Vaxneuvance is stable at temperatures up to 25 C for a maximum of 48 hours. If this period is exc eeded, the vaccine should be discarded.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

📄 Package Leaflet – official source

This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Vaxneuvance (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/21/1591).

⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.