PREVENAR 13 INJECTABLE SUSPENSION

2. What you need to know before you or your child receives Prevenar 13

Prevenar 13 must not be administered

• if you or your child isallergic (hypersensitive) to the active substances or to any of the other components of this medicine (listed in section 6) or to any other vaccine that contains diphtheria toxoid.
• if you or your child has a severe infection with a high temperature (over 38°C). If this happens to you or your child, vaccination should be postponed until you or your child is feeling better. A minor infection, such as a cold, should not be a problem. However, consult your doctor, pharmacist, or nurse beforehand.

Warnings and precautions

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

• has or has had any medical problems after receiving any dose of Prevenar or Prevenar 13, such as an allergic reaction or breathing problems.
• has bleeding problems or bruises easily.
• has a weakened immune system (e.g., due to HIV infection) may not get the full benefit from Prevenar 13.
• has had seizures, as it may be necessary to take medication to reduce fever before administering Prevenar 13. If your child does not respond to the medication or has seizures after vaccination, consult your doctor immediately. See also section 4.

Talk to your doctor, pharmacist, or nurse before vaccination if your child was very premature (born at 28 weeks of gestation or less), as the interval between breaths may be longer than normal during the 2-3 days following vaccination. See also section 4.

As with any vaccine, Prevenar 13 will not protect all vaccinated individuals.

Prevenar 13 will only protect against ear infections in children caused by the types of Streptococcus pneumoniaefor which the vaccine has been developed. It will not protect against other infectious agents that may cause ear infections.

Use of Prevenar 13 with other medicines/vaccines

Your doctor may recommend that you give your child paracetamol or other medicines that reduce fever before administering Prevenar 13. This will help reduce some of the side effects of Prevenar 13.

Tell your doctor, pharmacist, or nurse if you or your child is using, has recently used, or might use other medicines, including those bought without a prescription, or has recently received another vaccine.

Pregnancy and breastfeeding

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

Driving and using machines

Prevenar 13 has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned in section 4 "Possible side effects" may temporarily affect the ability to drive and use machines.

Prevenar 13 contains polysorbate 80

This vaccine contains 0.1 mg of polysorbate 80 per dose. Polysorbates may cause allergic reactions. Inform your doctor if you or your child has any known allergy.

Prevenar 13 contains sodium

This medicine contains less than 1 mmol of sodium (23 milligrams) per dose, i.e., it is essentially "sodium-free".

3. How Prevenar 13 is administered

The doctor or nurse will inject the recommended dose (0.5 ml) of the vaccine into a muscle in your arm or your child's arm or leg.

Infants from 6 weeks to 6 months of age

Generally, your child should receive an initial series of three injections of the vaccine, followed by a booster dose.

• The first injection can be given from 6 weeks of age.
• All injections should be given at least one month apart.
• A fourth injection (booster) will be given between 11 and 15 months of age.
• You will be told when to return with your child for the next injection.

According to the official recommendations in your country, the healthcare professional may follow an alternative schedule. Please ask your doctor, pharmacist, or nurse for more information.

Premature infants

Your child will receive an initial series of three injections. The first injection can be given from 6 weeks of age, with at least one month between doses. Between 11 and 15 months, your child will receive a fourth injection (booster).

Infants, children, and adolescents over 7 months of age who have not been vaccinated

Infants from 7 to 11 monthsof age should receive two injections. The injections will be given at least one month apart. A third injection will be given in the second year of life.

Children from 12 to 23 monthsof age should receive two injections. The injections will be given at least two months apart.

Children from 2 to 17 yearsof age should receive a single injection.

Infants, children, and adolescents previously vaccinated with Prevenar

Infants and children who have previously received Prevenar may receive Prevenar 13 to complete the series of injections.

In the case of children from 1 to 5 yearsof age previously vaccinated with Prevenar, your doctor or nurse will recommend how many injections of Prevenar 13 are needed.

Children and adolescents from 6 to 17 years of age should receive a single injection.

It is important to follow the instructions of your doctor, pharmacist, or nurse so that your child completes the series of injections.

If you forget to return at the scheduled time, consult your doctor, pharmacist, or nurse.

Adults

Adults should receive a single injection.

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

If you have any further questions about the use of Prevenar 13, ask your doctor, pharmacist, or nurse.

Special populations

Individuals who may be at higher risk of having a pneumococcal infection (e.g., those with sickle cell anemia or HIV infection), including those previously vaccinated with one or more doses of the 23-valent pneumococcal polysaccharide vaccine, may receive at least one dose of Prevenar 13.

Individuals who have undergone a stem cell transplant may receive three injections, the first of which is given between 3 and 6 months after the transplant, and the subsequent injections are given with a minimum interval of one month between doses. A fourth dose (booster) is recommended 6 months after the third injection.

4. Possible side effects

Like all vaccines, Prevenar 13 can cause side effects, although not everybody gets them.

The side effects observed with Prevenar 13 in infants and children (from 6 weeks to 5 years of age) include:

The most common side effects(which may affect more than 1 in 10 doses of the vaccine) are:

• Loss of appetite.
• Fever; irritability; pain, tenderness, or redness at the injection site, swelling, or hardening at the injection site; drowsiness; restless sleep.
• Redness, hardening, or swelling of 2.5 cm - 7 cm at the injection site (after the booster dose and in older children [between 2 and 5 years of age]).

Common side effects(which may affect up to 1 in 10 doses of the vaccine) are:

• Vomiting, diarrhea.
• Fever over 39°C; tenderness or pain at the injection site that interferes with movement of the limb, redness, swelling, or hardening of 2.5 cm - 7 cm at the injection site (after the initial series of injections).
• Rash.

Uncommon side effects(which may affect up to 1 in 100 doses of the vaccine) are:

• Seizures (including those caused by a high temperature).
• Hives (urticaria or urticaria-like rash).
• Redness, swelling, or hardening of more than 7 cm at the injection site; crying.

Rare side effects(which may affect up to 1 in 1,000 doses of the vaccine) are:

• Collapse or shock-like state (hypotonic hyporesponsive episode).
• Allergic reaction (hypersensitivity), including swelling of the face and/or lips, difficulty breathing.

The side effects observed with Prevenar 13 in children and adolescents (from 6 to 17 years of age) are:

The most common side effects(which may affect more than 1 in 10 doses of the vaccine) are:

• Loss of appetite.
• Irritability; pain, tenderness, or redness at the injection site, swelling, or hardening at the injection site; drowsiness; restless sleep; tenderness or pain at the injection site that interferes with movement of the limb.

Common side effects(which may affect up to 1 in 10 doses of the vaccine) are:

• Headache.
• Vomiting, diarrhea.
• Rash; hives (urticaria or urticaria-like rash).
• Fever.

Children and adolescents with HIV infection, sickle cell anemia, or who have undergone a stem cell transplant had similar side effects; however, the frequencies were very common in the case of headache, vomiting, diarrhea, fever, fatigue, joint pain, and muscle pain.

In very premature babies (born at 28 weeks of gestation or less), longer-than-normal intervals between breaths may occur during the 2-3 days following vaccination.

The following side effects have been observed with Prevenar 13 in adults:

The most common side effects(which may affect more than 1 in 10 doses of the vaccine) are:

• Loss of appetite; headache; diarrhea; vomiting (in individuals between 18 and 49 years of age).
• Chills; fatigue; skin rash; pain, redness, swelling, hardening, or tenderness at the injection site that interferes with arm movement (severe pain/tenderness at the injection site in individuals between 18 and 39 years of age and significant limitation of arm movement very common in individuals between 18 and 39 years of age).
• Worsening or new joint pain; worsening or new muscle pain.
• Fever (in individuals between 18 and 29 years of age).

Common side effects(which may affect up to 1 in 10 doses of the vaccine) are:

• Vomiting (in individuals 50 years of age or older); fever (in individuals 30 years of age or older).

Uncommon side effects(which may affect up to 1 in 100 doses of the vaccine) are:

• Nausea.
• Allergic reaction (hypersensitivity), including swelling of the face and/or lips, difficulty breathing.
• Enlarged lymph nodes (lymphadenopathy) near the injection site, e.g., under the arm.

Adults with HIV infection had similar side effects; however, the frequencies were very common in the case of fever and vomiting, and common in the case of nausea.

Adults who have undergone a stem cell transplant had similar side effects; however, the frequencies were very common in the case of fever and vomiting.

The following additional side effects have been observed with Prevenar 13 in the post-marketing experience:

• Severe allergic reaction, including shock (cardiovascular collapse); angioedema (swelling of the lips, face, or throat).
• Hives (urticaria), redness, and irritation of the skin (dermatitis), and itching (pruritus) at the injection site; flushing.
• Enlarged lymph nodes (lymphadenopathy) near the injection site, e.g., under the arm or in the groin.
• A rash with red spots that itch (erythema multiforme).

Reporting of side effects

If you or your child experiences 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 to the Spanish Medicines Agency: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Prevenar 13

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

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date is the last day of the month stated.

Store in a refrigerator (between 2°C and 8°C).

Do not freeze.

Prevenar 13 is stable at temperatures up to 25°C for four days. After this time, Prevenar 13 should be used or discarded. This information is intended to serve as a guide for healthcare professionals in case of a break in the cold chain.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container contents and additional information

Prevenar composition13

The active ingredients are polysaccharide conjugates with CRM197 composed of:

• 2.2 µg of polysaccharides from serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F
• 4.4 µg of polysaccharide from serotype 6B

1 dose (0.5 ml) contains approximately 32 µg of carrier protein CRM197 adsorbed on aluminum phosphate (0.125 mg of aluminum).

The other components are sodium chloride, succinic acid, polysorbate 80, and water for injectable preparations.

Appearance of Prevenar13 and container contents

The vaccine is a white injectable suspension in a single-dose pre-filled syringe (0.5 ml).

Presentation of 1, 10, and 50, with or without a needle. Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

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

Date of last revision of this leaflet: 04/2025

Other sources of information

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

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This information is intended solely for healthcare professionals:

During storage, a white sediment and a clear supernatant may be observed. This does not constitute a sign of deterioration.

Inspect visually for particles and/or abnormal physical appearance; do not use in such cases.

Before expelling air from the syringe, shake well to obtain a homogeneous white suspension.

Administer the entire dose.

Prevenar 13 is for intramuscular administration only. Do not administer intravascularly.

Prevenar 13 should not be mixed with any other vaccine in the same syringe.

Prevenar 13 may be administered at the same time as other infant vaccines; in such cases, different injection sites should be used.

Prevenar 13 may be administered to adults 50 years of age or older at the same time as the trivalent or tetravalent inactivated influenza vaccine.

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