InfoCons Consumer Protection informs you – CAPVAXIVE – Package Leaflet

Before anything else

Read all of this leaflet carefully before you or your child are 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 or your child get any side effects, talk to your doctor , pharmacist or nurse. This includes any possible side effects not listed in this leaflet . See section 4.

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

CAPVAXIVE is a pneumococcal vaccine given to:

• people aged 18 years and older
• children and adolescents 2 to less than 18 years of age who have previously completed the routine pneumococcal vaccination schedule for children .

This vaccine helps to protect against illnesses caused by a bacteri um called Streptococcus pneumoniae or pneumococcus. These diseases include : lung infection (pneumonia) , inflammation of the brain and spinal cord (meningitis) and infection in the blood (bacter aemia) .

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

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

Do not re ceive CAPVAXIVE :

• if you or your child are allergic to the active substances , including diphtheria toxoid, or to any of the ingredients of this vaccine (listed in section 6).

Warnings and precautions

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

• you or your child have a high fever or severe infection. In these cases, the vaccination may have to be postponed until you or they have recovered. However, a mild fever or infection (for example having a cold) itself is not a reason to delay vaccination.
• You or your child have any bleeding problems, bruise easily, or are taking medicines to prevent blood clots .

25• you or your child have anxiety related to injections or have ever fainted after any injection.

• your or your child’s immune system is weak ened (which means the body is less able to fight off infections) or if you or your child are taking certain medicines that may weaken the immune system .

As with any vaccine, CAPVAXIVE may not fully protect all those who get the vaccine .

Children

CAPVAXIVE has not been studied in children younger than 2 years of age.

Other medicines/vaccines and CAPVAXIVE CAPVAXIVE can be given to adults at the same time as the flu vaccine (inactivated influenza) .

Tell your doctor, pharmacist, or nurse if:

• you or your child are taking, ha ve recently taken, or might take any other medicines .
• you or your child have recently received or plan to receive any other vaccine.

Pregnancy 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 receiv e this vaccine.

Driving and using machines

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

CAPVAXIVE contains sodium

This medicine contains less than 1 mmol sodium ( 23 mg) per dose, that is to say essentially ‘sodium – free’.

CAPVAXIVE contains polysorbate 20

This medicine contains 0.5 mg of polysorbate 20 in each 0.5 mL dose of solution for injection.

Polysorbates may cause allergic reactions. Tell your doctor if you or your child have any known allergies.

💊 3. How CAPVAXIVE is given

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

You or your child will receive 1 injection (1 dose of 0.5 mL).

Your doctor , pharmacist or nurse will give the vaccine into the upper arm muscle .

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

❗ 4. Possible side effects

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

Serious side effects

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

CAPVAXIVE may cause allergic (hypersensitivity) reactions including excessive contraction of the airway muscles causing breathing difficulty (bronchospasm). Get medical care right away if you or your child have symptoms of an allergic reaction, which may include:

• Wheezing or trouble breathing 26• Swelling of the face, lips, or tongue
• Hives
• Rash

Other side effects

The following side effects have been seen after the use of CAPVAXIVE in adults :

Very common (may affec t more than 1 in 10 people)

• Headaches
• Pain at the injection site
• Feeling tired

Common (may affect up to 1 in 10 people)

• Muscle aches (very common in people 18 to 49 years of age)
• Redness or swelling at the injection site (very common in people 18 to 49 years of age)
• Fever

Uncommon (may affect up to 1 in 100 people)

• Swelling of lymph nodes
• Dizziness
• Feeling sick (nausea)
• Diarrhoea
• Vomiting
• Joint pain
• Itching at injection site
• Chills
• Bruising at injection site The following side effects have been seen after the use of CAPVAXIVE in children and adolescents 2 to less than 18 years of age:

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

• Irritability
• Headaches
• Pain at the injection site
• Feeling tired
• Redness or swelling at the injection site
• Feeling of illness, discomf ort, or unease

Common (may affect up to 1 in 10 people)

• Feeling sleepy
• Hives
• Muscle aches
• Joint pain
• Fever

Uncommon (may affect up to 1 in 10 0 people)

• Fainting These side effects are generally mild or moderate and last a short time.

Reporting of side effects

If you get 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 27system listed in Appendix V . By reporting side ef fects, you can help provide more information on the safety of this medicine.

🌡️ 5. How to store CAPVAXIVE

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 syringe in the outer carton in order to protect from light.

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

However, in circumstances where CAPVAXIVE is temporarily held outside of refrigeration, the vaccine is stable at temperatures up to 25 °C for 96 hours. At the end of thi s time period CAPVAXIVE should be used or discarded. Th is information is intended to guide healthcare professionals in case of temporary temperature excursions only.

📦 6. Contents of the pack and other information

What CAPVAXIVE contains

The active substances are:

• Polysaccharides from pneumococcus types 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, de-O- acetylated type 15B, 16F, 17F, 19A, 20 A, 22F, 23A, 23B, 24F, 31, 33F and 35B (4 micrograms of each type);

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

One dose (0.5 mL) contains approximately 6 5 micrograms carrier protein.

The other ingredients are sodium chloride (NaC l), histidine, polysorbate 20 (E432) , hydrochloric acid (HCl; for pH adjustment) and water for in jection s. For more information on polysorbate 20 (E432), see Section 2.

What CAPVAXIVE looks like and contents of the pack

CAPVAXIVE is a colourless, clear to opalescent solution for injection (injection) , provided in a single -dose, pre -filled syringe (0.5 mL). CAPVAXIVE is available in pack sizes of 1 or 10 pre-filled syringes, either without needles, with 1 separate needle or with 2 separate needles per pre -filled syringe .

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] 28България 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) dpoccyprus@m sd.com Deutschland MSD Sharp & Dohme GmbH Tel.: +49 (0) 89 20 300 4500 medinfo @msd.deNederland Merck Sharp & Dohme B.V.

Tel: 0800 9999000 (+31 23 5153153) medicalinfo. [email protected] Eesti Merck Sharp & Dohme OÜ Tel: +372 614 4200 [email protected] Norge 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 [email protected] 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 4465 700 inform_pt@ msd.com Hrvatska Merck Sharp & Dohme d.o.o.

Tel: +385 1 6611 333 dpoc. croatia@m sd.comRomânia 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@m sd.comSlovenija Merck Sharp & Dohme, inovativna zdravila d.o.o.

Tel: +386 1 520 4201 msd.slovenia@ msd.com 29Ísland 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) [email protected]/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 650 [email protected] Κύπρος Merck Sharp & Dohme Cyprus Limited Τηλ: 800 00 673 (+357 22866700) dpoccyprus@m sd.comSverige 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 i n {MM/YYYY}.

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

• The vaccine should be used as supplied.
• Inspect the solution visually for particulate matter and discolouration prior to administration.

Discard the vaccine if particulates are present 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 syringe.
• CAPV AXIVE should be administered by intramuscular injection only. This vaccine should be administered preferably in the deltoid muscle of the upper arm, with care to avoid injection into or near nerves and blood vessels.

CAPVAXIVE can be administered concomitantly with quadrivalent influenza vaccine (split virion, inactivated) in adults. Dif ferent injectable vaccines should always be administered at different injection sites.

Any unused medicinal product or waste material should b e 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 CAPVAXIVE (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/25/1913).

⚠️ 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.