Vaxneuvance suspensiÓn inyectable en jeringa precargada

Prospect: information for the user

Vaxneuvance pre-filled syringe suspension

Conjugated pneumococcal polysaccharide vaccine (15-valent, adsorbed)

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects that you or your child may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before you or your child receives this vaccine, because it containsimportant information for you.

-Keep this prospect, as you may need to refer to it again.

-If you have any doubts, consult your doctor, pharmacist or nurse.

-This vaccine has been prescribed only for you or your child, and must not be given to other people.

-If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

1.What is Vaxneuvance and what it is used for

2.What you need to know before receiving Vaxneuvance

3.How Vaxneuvance is administered

4.Possible adverse effects

5.Storage of Vaxneuvance

6.Contents of the package and additional information

Vaxneuvance is a pneumococcal conjugate vaccine for

• children from 6 weeks to 18 years of ageto help protect them against diseases such as pneumonia, meningitis (inflammation of the membranes covering the brain and spinal cord), sepsis (a severe infection in the blood), and acute otitis media (ear infections),
• individuals 18 years of age and olderto help protect them against diseases such as pneumonia, meningitis, and sepsis caused by 15 types of the bacterium Streptococcus pneumoniae or pneumococcus.

You should not receive Vaxneuvance if:

• you or your child is allergic to the active ingredients or to any of the other components of this vaccine (listed in section 6) or to any other vaccine that contains diphtheria toxoid.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before you or your child receive Vaxneuvance if:

• you have a weakened immune system (meaning your body is less able to fight off infections) or if you or your child is taking certain medications that may weaken the immune system (such as immunosuppressants or steroids).
• you or your child has a high fever or a serious infection. In these cases, you may need to postpone the vaccination until you or your child has recovered. However, a moderate fever or an infection (such as a cold) does not justify delaying the vaccination.
• you or your child has any bleeding problems, bruise easily, or is taking medications to prevent blood clotting.

If your child is a newborn, inform your doctor if your child was born prematurely (too early).

Like any vaccine, Vaxneuvance may not protect all people who are vaccinated.

Other medications/vaccines and Vaxneuvance

Your child may receive Vaxneuvance at the same time as other routine childhood vaccines.

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

Inform your doctor, pharmacist, or nurse if:

• you or your child is taking, has taken recently, or may need to take any other prescription medication (such as immunosuppressants or steroids that may weaken the immune system) or any over-the-counter medication.
• you or your child has received recently or plans to receive any other vaccine.

Pregnancy and breastfeeding

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

Driving and operating machinery

The influence of Vaxneuvance on the ability to drive and operate machinery is negligible. However, some of the adverse effects mentioned in section 4 "Possible adverse effects" may temporarily affect the ability to drive or operate machinery.

Vaxneuvance contains sodium

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

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

Your doctor or nurse will administer the vaccine in the muscle of your arm or your child's arm or leg.

Infants and children from 6 weeks to 2 years of age

Your child should receive an initial regimen of 2 injections of the vaccine followed by a booster dose.

• The first injection can be administered from 6 weeks of age.
• A second injection is administered 2 months later.
• A third injection (booster) will be administered between 11 and 15 months of age.

You will be informed when your child should return for each injection.

According to official recommendations in your country, an alternative regimen of 3 injections followed by a booster dose may be used. Consult with your doctor, pharmacist, or nurse for more information.

Preterm infants (born before 37 weeks of gestation)

Your child should receive an initial regimen of 3 injections of the vaccine followed by a booster dose.

• The first injection can be administered from 6 weeks of age.
• The second and third injections are administered subsequently with an interval of 4 to 8 weeks between these doses.
• A fourth injection (booster) will be administered between 11 and 15 months of age.

Infants, children, and adolescents initiating vaccination from 7 months of age

Children between 7 and 12 months of age should receive a total of 3 injections. The first two injections will be administered with an interval of at least 1 month. The third injection (booster) will be administered from 12 months of age and at least 2 months after the second injection.

Children between 12 months and 2 years of age should receive a total of 2 injections. The two injections will be administered with an interval of at least 2 months.

Children and adolescents between 2 and 18 years of age should receive 1 injection.

Adults

Adults should receive 1 injection.

Special populations

One or more doses of Vaxneuvance may be administered to individuals with one or more underlying conditions that increase the risk of pneumococcal disease (such as individuals with sickle cell anemia or human immunodeficiency virus infection [HIV] or recipients of a hematopoietic stem cell transplant).

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

Like all vaccines, Vaxneuvance may cause side effects, although not everyone will experience them.

Seek medical attention immediately ifyou or your childhas symptoms of an allergic reaction, which may be:

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

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

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

• Fever(temperature of38°C or higher in infants and children aged 6weeks to 2years)
• Irritability (in infants and children aged 6weeks to 2years)
• Drowsiness (in infants and children aged 6weeks to 2years)
• Pain, redness, or swelling at the injection site
• Loss of appetite (in infants and children aged 6weeks to 2years)
• Induration at the injection site (in infants and children aged 6weeks to 2years)
• Muscle pain (in children and adolescents aged 2 to 18 years)
• Fatigue (in children and adolescents aged 2 to 18years)
• Headache (in children and adolescents aged 2 to 18years)

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

• Induration at the injection site (in children and adolescents aged 2 to 18years)
• Hives

• Fever (temperature of38°C or higherin children and adolescents aged 2 to 18years)

• Vomiting (in infants and children aged 6weeks to 2years)
• Rash(in infants and children aged 6weeks to 2years)
• Irritability (in children and adolescents aged 2 to 18years)
• Drowsiness (in children and adolescents aged 2 to 18years)
• Loss of appetite (in children and adolescents aged 2 to 18years)
• Cardinal signs at the injection site
• Nausea (in children and adolescents aged 2 to 18years)

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

• Vomiting (in children and adolescents aged 2 to 18 years)

Frequency not known(cannot be estimated from available data):

• Rash(in children and adolescents aged 2 to 18 years)

The following side effects may be observed after the use of Vaxneuvance in adults:

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

• Pain, redness, or swelling at the injection site
• Fatigue
• Muscle pain
• Headache
• Joint pain (in adults aged 18 to 49years)

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

• Joint pain (in adults aged 50years or older)
• Nausea (in adults aged 18 to 49 years)
• Fever (in adults aged 18 to 49years)
• Itching at the injection site
• Dizziness (in adults aged 18 to 49years)
• Chills (in adults aged 18 to 49 years)

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

• Fever (in adults aged 50years or older)
• Heat at the injection site
• Cardinal signs at the injection site
• Dizziness (in adults aged 50years or older)
• Nausea (in adults aged 50years or older)
• Vomiting
• Chills(in adults aged 50years or older)
• Rash

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

• Allergic reactions such as hives, swelling of the tongue, redness, and sensation of throat constriction

These side effects are generally mild and short-lived.

Reporting of side effects

If you or your child experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through thenational notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this vaccine out of sight and reach of children.

Do not use this vaccine after the expiration date that appears on the box and on the syringe label after CAD or EXP. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2?C and 8?C). Do not freeze. Keep the pre-filled syringe in the outer packaging to protect it from light.

Vaxneuvance should be administered as soon as possible once it is out of the refrigerator. However, in circumstances where Vaxneuvance is temporarily kept out of the refrigerator, stability data indicate that the vaccine is stable at temperatures up to 25°C for 48 hours.

Composition of Vaxneuvance

The active principles are:

• bacterial polysaccharides of the serotypes pneumococcal 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F (2.0 micrograms of each serotype);
• bacterial polysaccharide of pneumococcal serotype 6B (4.0 micrograms).

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

Each dose of 0.5 ml contains approximately 30 micrograms of carrier protein, adsorbed in aluminum phosphate (125 micrograms of aluminum [Al 3+]). Aluminum phosphate is included in the vaccine as an adjuvant. Adjuvants are included to increase immune responses to vaccines.

The other components are sodium chloride (NaCl), L-histidine, polysorbate 20, and water for injection.

Appearance of Vaxneuvance and contents of the package

Vaxneuvance is an opalescent injectable suspension in a pre-filled syringe of single dose (0.5 ml). Vaxneuvance is presented in packaging sizes of 1 or 10 pre-filled syringes, without needles, with 1 separate needle or with 2 separate needles.

Vaxneuvance is also available in multi-packaging that contains 5 packages, each with 10 pre-filled syringes without needles.

Only some packaging sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Last review date of this leaflet:{MM/AAAA}.

Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

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This information is intended solely for healthcare professionals:

Vaxneuvance must not be administered by intravascular injection.

• Immediately before using the vaccine, hold the pre-filled syringe horizontally and shake vigorously to obtain an opalescent suspension. Do not use the vaccine if it cannot be resuspended.
• Visually inspect the suspension to detect particles and discoloration before administration. Discard the vaccine if particles are detected and/or if it appears discolored.
• Secure the needle with Luer Lock connection by turning clockwise until the needle fits securely into the syringe.
• Inject immediately by intramuscular (IM) route, preferably in the anterolateral thigh in infants or in the deltoid area of the upper arm in children and adults.
• Be careful to avoid accidental needlestick injury.

No data are available on the administration by intradermal route.

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

Vaxneuvance can be administered concomitantly with routine childhood vaccines.

Vaxneuvance can be administered concomitantly with the seasonal trivalent influenza vaccine (inactivated virus) in adults.

Different injectable vaccines must always be administered in different injection sites.

Store in refrigerator (between 2°C and 8°C). Do not freeze.

Keep the pre-filled syringe in the outer packaging to protect it from light.

Vaxneuvance must be administered as soon as possible once it is removed from the refrigerator.

In case of temporary deviations from temperature, the stability data indicate that Vaxneuvance is stable at temperatures up to 25°C for 48 hours.

The disposal of unused medicinal product and of all materials that have been in contact with it will be carried out in accordance with local regulations.