Prevenar 13 injectable suspension

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Prevenar 13 injectable suspension

13-valent adsorbed pneumococcal conjugate vaccine

Read all of this leaflet carefully before you or your child is vaccinated, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This vaccine has been prescribed for you or your child only, and must not be passed on to others.
• If you or your child experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Leaflet contents

1. What Prevenar 13 is and what it is used for
2. What you need to know before you or your child receives Prevenar 13
3. How Prevenar 13 is administered
4. Possible side effects
5. How to store Prevenar 13
6. Contents of the pack and other information

1. What Prevenar 13 is and what it is used for

Prevenar 13 is a pneumococcal vaccine given to:

• children from 6 weeks to 17 years of age: to help protect them against diseases such as: meningitis (inflammation around the brain), sepsis or bacteremia (bacteria in the bloodstream), pneumonia (lung infection), and ear infections,
• adults 18 years of age or older: to help prevent diseases such as: pneumonia (lung infection), sepsis or bacteremia (bacteria in the bloodstream), and meningitis (inflammation around the brain),

caused by 13 types of the bacterium Streptococcus pneumoniae.

Prevenar 13 provides protection against 13 types of the bacterium Streptococcus pneumoniae and replaces Prevenar, which provided protection against 7 types.

The vaccine works by helping the body produce its own antibodies, which protect you or your child against these diseases.

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

Do not administer Prevenar13

• if you or your child are allergic (hypersensitive) to the active substances or to any of the other components of this medicine (listed in section 6) or to any other vaccine containing diphtheria toxoid.
• if you or your child have a serious infection with high fever (above 38°C). If this applies to you or your child, vaccination should be postponed until you or your child feel better. A minor infection, such as a cold, should not be a problem. However, consult your doctor, pharmacist, or nurse before proceeding.

Warnings and precautions

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

• have had or have previously had any medical problems after receiving any dose of Prevenar or Prevenar 13, such as an allergic reaction or breathing difficulties.
• have bleeding disorders or bruise easily.
• have a weakened immune system (for example, due to HIV infection), as you or your child may not receive the full benefit from Prevenar 13.
• have experienced seizures, as it may be necessary to administer fever-reducing medication before administering Prevenar 13. If your child does not respond to the medication or has seizures after vaccination, contact your doctor immediately. See also section 4.

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

As with any vaccine, Prevenar 13 may not protect all individuals who receive it.

Prevenar 13 will only protect against ear infections in children caused by the types of Streptococcus pneumoniae included in the vaccine. It will not protect against other infectious agents that may cause ear infections.

Use of Prevenar13 with other medicines/vaccines

Your doctor may recommend giving your child paracetamol or other fever-reducing medicines before administering Prevenar 13. This will help reduce some of the adverse effects associated with Prevenar 13.

Tell your doctor, pharmacist, or nurse if you or your child are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription, or if you or your child have recently received another vaccine.

Pregnancy and breastfeeding

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

Driving and using machines

The effect of Prevenar 13 on the ability to drive and operate machinery is negligible or none. However, some of the effects mentioned in section 4, “Possible adverse effects,” may temporarily affect the ability to drive and operate machinery.

Prevenar13 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 have any known allergies.

Prevenar13 contains sodium

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

3. How Prevenar 13 is given

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

Infants from 6 weeks to 6 months of age

Your child should generally receive an initial series of three vaccine injections, followed by a booster dose.

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

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

Premature infants

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

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

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

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

Children 2 to 17 years of 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 injection series.

For children 1 to 5 years of age previously vaccinated with Prevenar, your doctor or nurse will advise how many doses of Prevenar 13 are needed.

Children and adolescents 6 to 17 years of age should receive one 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 miss a scheduled appointment, consult your doctor, pharmacist, or nurse.

Adults

Adults should receive a single injection.

Inform 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 increased risk of 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 hematopoietic stem cell transplantation may receive three injections, the first of which is administered between 3 and 6 months after transplantation, with subsequent doses given at least one month apart. A fourth dose (booster) is recommended 6 months after the third injection.

4. Possible adverse effects

Like all vaccines, Prevenar 13 may cause adverse effects, although not everyone experiences them.

The adverse effects observed with Prevenar13 in infants and children (from 6 weeks to 5 years of age) include the following:

Very common adverse effects (may occur in more than 1 in 10 doses of the vaccine) are:

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

Common adverse effects (may occur in up to 1 in 10 doses of the vaccine) are:

• Vomiting, diarrhea
• Fever above 39°C; tenderness or pain on palpation at the injection site interfering with limb movement, redness, swelling or hardening of 2.5 cm – 7 cm at the injection site (after the primary series of injections).
• Rash

Uncommon adverse effects (may occur in up to 1 in 100 doses of the vaccine) are:

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

Rare adverse effects (may occur in 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 adverse effects observed with Prevenar13 in children and adolescents (from 6 to 17 years of age) are the following:

Very common adverse effects (may occur in more than 1 in 10 doses of the vaccine) are:

• Decreased appetite.
• Irritability; pain, tenderness or pain on palpation, redness, swelling or hardening at the injection site; somnolence; restless sleep; tenderness or pain on palpation at the injection site interfering with limb movement.

Common adverse effects (may occur in up to 1 in 10 doses of the vaccine) are:

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

Children and adolescents with HIV infection, sickle cell anemia, or who had undergone a hematopoietic stem cell transplant experienced similar adverse effects; however, the frequencies of headaches, vomiting, diarrhea, fever, fatigue, joint pain, and muscle pain were very common.

In very premature infants (born at 28 weeks of gestation or earlier), prolonged periods of apnea (pauses in breathing) may occur for 2–3 days after vaccination.

The following adverse effects have been observed with Prevenar13 in adults:

Very common adverse effects (may occur in more than 1 in 10 doses of the vaccine) are:

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

Common adverse effects (may occur in up to 1 in 10 doses of the vaccine) are:

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

Uncommon adverse effects (may occur in up to 1 in 100 doses of the vaccine) are:

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

Adults with HIV infection experienced similar adverse effects; however, the frequencies of fever and vomiting were very common, and nausea was common.

Adults who had undergone a hematopoietic stem cell transplant experienced similar adverse effects; however, the frequencies of fever and vomiting were very common.

In post-marketing experience with Prevenar13, the following additional adverse effects have been observed:

• 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 (redness of the face or skin).
• Enlargement of lymph nodes (lymphadenopathy) near the injection site, for example, under the arm or in the groin.
• A rash with itchy red spots (erythema multiforme).

Reporting of adverse effects

If you or your child experience any adverse effects, talk to your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 stated on the packaging and label after EXP. The expiry date is the last day of the month indicated.

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

Do not freeze.

Prevenar 13 is stable at temperatures up to 25°C for up to four days. After this period, Prevenar 13 must be used or discarded. This information is intended as guidance for healthcare professionals in the event 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 and packaging you no longer need. This will help protect the environment.

6. Package contents and other information

Composition of Prevenar13

The active substances are polysaccharides conjugated to 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

One dose (0.5 ml) contains approximately 32 µg of CRM197 carrier protein adsorbed onto aluminium phosphate (0.125 mg of aluminium).

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

Appearance of Prevenar13 and contents of the pack

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

Pack sizes of 1, 10 and 50, with or without needles. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
Pfizer Limited
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Manufacturer:
Pfizer Manufacturing Belgium BVBA
Rijksweg 12
B-2800 Mechelen
Belgium

You can request further information about this medicinal product by contacting the local representative of the marketing authorization holder:

Date of latest review of this leaflet: 04/2025

Other sources of information

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

This information is intended for healthcare professionals only:

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

Visually inspect for particles and/or abnormal physical appearance; do not use if such conditions are observed.

Before expelling air from the syringe, shake well until a homogeneous white suspension is obtained.

Administer the entire dose.

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

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

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

Prevenar 13 may be administered simultaneously in adults aged 50 years or older with inactivated trivalent or quadrivalent influenza vaccine.

Disposal of unused medicine and of all materials that have come into contact with it must be carried out in accordance with local regulations.