VAXNEUVANCE Injectable Suspension in Pre-filled Syringe

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

Vaxneuvance should not be given if:

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

Warnings and precautions

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

• you or your child has a weakened immune system (which means the body is less able to fight infections) or if you or your child is taking certain medicines that can weaken the immune system (such as immunosuppressants or steroids).
• you or your child has a high fever or a severe infection. In these cases, vaccination may need to be postponed until you or your child has recovered. However, a moderate fever or infection (such as a cold) does not justify delaying vaccination.
• you or your child has any bleeding problems, bruises easily, or is taking medicines to prevent blood clotting.

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

Like all vaccines, Vaxneuvance may not fully protect all people who are vaccinated.

Other medicines and vaccines and Vaxneuvance

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

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

Tell your doctor, pharmacist, or nurse if:

• you or your child is taking, has recently taken, or might take any other medicines (including those obtained without a prescription), such as immunosuppressants or steroids that can weaken the immune system.
• you or your child has recently received or is scheduled to receive any other vaccine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before receiving this vaccine.

Driving and using machines

Vaxneuvance has no or negligible influence on the ability to drive and use machines. However, some of the side effects mentioned in 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 of sodium (23 mg) per dose, which is essentially "sodium-free".

3. How Vaxneuvance is administered

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

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

Infants and children from 6 weeks to 2 years of age

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

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

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

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

Premature infants (born before 37 weeks of gestation)

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

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

Infants, children, and adolescents who start vaccination from 7 months of age

Children from 7 to 12 monthsof age should receive a total of 3 injections. The first two injections are given at an interval of at least 1 month. The third injection (booster) is given from 12 months of age and at least 2 months after the second injection.

Children from 12 months to 2 yearsof age should receive a total of 2 injections. The two injections are given at an interval of at least 2 months.

Children and adolescents from 2 to 18 yearsof age should receive 1 injection.

Adults

Adults should receive 1 injection.

Special populations

Vaxneuvance can be given to individuals with one or more underlying diseases that increase the risk of pneumococcal disease (such as individuals with sickle cell disease or human immunodeficiency virus [HIV] infection or stem cell transplant recipients).

If you have any other questions about 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.

Seek medical attention immediately if you or your child experience symptoms of an allergic reaction, which can be:

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

The following side effects have been observed after use of Vaxneuvance in infants, children, and adolescents:

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

• Fever (temperature of 38°C or higher in infants and children from 6 weeks to 2 years of age)
• Irritability (in infants and children from 6 weeks to 2 years of age)
• Somnolence (in infants and children from 6 weeks to 2 years of age)
• Pain, redness, or swelling at the injection site
• Loss of appetite (in infants and children from 6 weeks to 2 years of age)
• Induration at the injection site (in infants and children from 6 weeks to 2 years of age)
• Muscle pain (in children and adolescents from 2 to 18 years of age)
• Fatigue (in children and adolescents from 2 to 18 years of age)
• Headache (in children and adolescents from 2 to 18 years of age)

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

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

• Fever (temperature of 38°C or higher in children and adolescents from 2 to 18 years of age)

• Vomiting (in infants and children from 6 weeks to 2 years of age)
• Rash (in infants and children from 6 weeks to 2 years of age)
• Irritability (in children and adolescents from 2 to 18 years of age)
• Somnolence (in children and adolescents from 2 to 18 years of age)
• Loss of appetite (in children and adolescents from 2 to 18 years of age)
• Bruising at the injection site
• Nausea (in children and adolescents from 2 to 18 years of age)

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

• Vomiting (in children and adolescents from 2 to 18 years of age)

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

• Rash (in children and adolescents from 2 to 18 years of age)

The following side effects have been observed after use of Vaxneuvance in adults:

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

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

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

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

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

• Fever (in adults 50 years of age or older)
• Heat at the injection site
• Bruising at the injection site
• Dizziness (in adults 50 years of age or older)
• Nausea (in adults 50 years of age or older)
• Vomiting
• Chills (in adults 50 years of age or older)
• Rash

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

• Allergic reactions such as hives, swelling of the tongue, redness, and feeling of compression in the throat

These side effects are generally mild and short-lived.

Reporting of side effects

If you or your child experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through 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. Storage of 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 on the label of the syringe after CAD or EXP. The expiry date is the last day of the month shown.

Store in a 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 stored out of the refrigerator, stability data indicate that the vaccine is stable at temperatures up to 25°C for 48 hours.

6. Container Contents and Additional Information

Vaxneuvance Composition

The active ingredients are:

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

Each bacterial polysaccharide is conjugated to a carrier protein (CRM197). The bacterial polysaccharides and the carrier protein are not live and do not cause disease.

Each 0.5 mL dose contains approximately 30 micrograms of carrier protein, adsorbed on aluminum phosphate (125 micrograms of aluminum [Al3+]). Aluminum phosphate is included in the vaccine as an adjuvant. Adjuvants are included to enhance immune responses to vaccines.

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

Vaxneuvance Appearance and Container Contents

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

Vaxneuvance is also available in multipacks containing 5 packs, each with 10 prefilled syringes without needles.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Merck Sharp & Dohme B.V.

Waarderweg 39

2031 BN Haarlem

Netherlands

For further information on this medicinal product, please contact the local representative of the marketing authorization holder:

Date of Last Revision of this Leaflet:{MM/YYYY}.

Other Sources of Information

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

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This information is intended for healthcare professionals only:

Vaxneuvance should not be injected intravascularly.

• Immediately before use, hold the prefilled syringe horizontally and shake vigorously to obtain an opalescent suspension. Do not use the vaccine if it cannot be resuspended.
• Visually inspect the suspension for particles and discoloration before administration. Discard the vaccine if particles are present and/or if it appears discolored.
• Attach the needle with a Luer Lock connection by twisting in a clockwise direction until the needle is securely attached to the syringe.
• Inject immediately by the 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 intradermal administration.

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

Vaxneuvance can be administered concomitantly with other routine childhood vaccines.

Vaxneuvance can be administered concomitantly with the tetravalent seasonal influenza vaccine (fractionated, inactivated) in adults.

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

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

Keep the prefilled 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.

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

Disposal of unused medicinal products and all materials that have come into contact with them should be done in accordance with local regulations.