Vaxneuvance - patient leaflet, side effects, dosage

1. What Vaxneuvance is and what it is used for

Vaxneuvance is a pneumococcal vaccine given to help protect against diseases caused by 15 types of bacteria called Streptococcus pneumoniae or pneumococcus in individuals 18 years of age and older.

These diseases include lung infection (pneumonia), inflammation of the coverings of the brain and spinal cord (meningitis), and a severe infection in the blood (bacteraemia).

2. What you need to know before you receive Vaxneuvance

Do not receive Vaxneuvance if:

• you are 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 receive Vaxneuvance if:

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

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

Children and adolescents

It has not been established whether Vaxneuvance can be used in children and adolescents younger than 18 years of age.

Other medicines/vaccines and Vaxneuvance

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

Tell your doctor, pharmacist, or nurse if:

• you are taking, have recently taken, or might take any prescription medicines (for example, immunosuppressants or steroids which may make your immune system weak) or any medicines obtained without a prescription.
• you 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 receive this vaccine.

Driving and using machines

Vaxneuvance 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 use machines.

Vaxneuvance contains sodium

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

• 3. How Vaxneuvance is given

One injection of Vaxneuvance is given by your doctor, pharmacist or nurse into your muscle (preferably in your upper arm).

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

Special populations

One injection of Vaxneuvance may be given to individuals who have one or more underlying conditions that increase their risk for pneumococcal disease (such as those living with human immunodeficiency virus [HIV]).

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.

Get medical care right away if you have symptoms of an allergic reaction, which may include:

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

The following side effects can be seen after the use of Vaxneuvance:

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

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

Common (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

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

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.

Tell your healthcare provider about these side effects or any other unusual symptoms that develop after you receive this vaccine.

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 system listed in 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 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. However, in circumstances where Vaxneuvance is temporarily held outside of refrigeration, the vaccine is stable at temperatures up to 25 °C for 48 hours.

6. Contents of the pack and other information

What Vaxneuvance contains

The active substances are:

• – bacterial sugars from pneumococcus 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 pneumococcus type 6B (4.0 micrograms).

Each bacterial sugar is linked to a carrier protein (CRM197). 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 micrograms 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 chloride (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 separate needle, or with 2 separate 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:

Tel: 0800 673 673 673 (+49 (0) 89 4561 0)	Tel: 0800 9999000 (+31 23 5153153)
Eesti Merck Sharp & Dohme OÜ Tel.: +372 6144 200	Norge MSD (Norge) AS Tlf: +47 32 20 73 00
EZZárta MSD A.O.B.E.E. TnX: +30 210 98 97 300	Österreich Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044
España Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00	Polska MSD Polska Sp. z o.o. Tel.: +48.22.549.51.00
France MSD VACCINS Tél: +33 (0) 1 80 46 40 40	Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465700
Hrvatska Merck Sharp & Dohme d.o.o. Tel: +385 1 66 11 333	România Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 00
Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700	Slovenija Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386.1.520.4201
Ísland Vistor hf. Sími: + 354 535 7000	Slovenská republika Merck Sharp & Dohme, s. r. o Tel: +421 2 58282010
Italia MSD Italia S.r.l. Tel: +39 06 361911	Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 650
Kùnpoç Merck Sharp & Dohme Cyprus Limited TnX: 800 00 673 (+357 22866700)	Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488
Latvija SIA Merck Sharp & Dohme Latvija Tel: +371.67364.224	United Kingdom (Northern Ireland) Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700

This leaflet was last revised in {MM/YYYY }.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:.

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The following information is intended for healthcare professionals only:

Vaxneuvance must not be injected intravascularly.

• Immediately prior to use, hold the pre-filled syringe horizontally and shake vigorously to obtain

an opalescent suspension. Do not use the vaccine if it cannot be resuspended.

• Inspect the suspension 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.
• Inject immediately using the intramuscular (IM) route, preferably in the deltoid area of the upper arm.
• Exercise care to avoid harm from an accidental needle stick.