Prevenar 13 suspension inyectable

Prospect: information for the user

Prevent13 injectable suspension

Conjugated pneumococcal polysaccharide vaccine (13-valent, adsorbed)

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nursing staff.
• This vaccine has been prescribed only for you or your child, and must not be given to other people.
• If you or your child experience adverse effects, consult your doctor, pharmacist, or nursing staff, even if they do not appear in this prospect. See section 4.

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

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

3. How Prevenar 13 is administered

4. Possible adverse effects

5. Storage of Prevenar 13

6. Contents of the package and additional information

Prevenar13 is a pneumococcal conjugate vaccine administered to:

• children from 6weeks to 17years 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 bacteriaStreptococcus pneumoniae.

Prevenar13 provides protection against 13 types of the bacteriaStreptococcus pneumoniaeand replaces Prevenar, which provided protection against 7types.

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

You should not administer Prevenar13

• if you or your child isallergic (hypersensitive) to the active ingredients or to any of the other components of this medication (listed in section6) or to any other vaccine that contains diphtheria toxoid.
• if you or your child has a severe infection with high temperature (above 38°C). If this happens to you or your child, the 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 with your doctor, pharmacist, or nurse beforehand.

Warnings and precautions

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

• has or has had in the past any medical problem after administration of any dose of Prevenar or Prevenar13, such as an allergic reaction or breathing problems.
• has bleeding problems or easily gets bruises.
• has a weakened immune system (for example, due to HIV infection) may not get the full benefit of Prevenar13.
• has had seizures, as it may be necessary to take medications to lower fever before administering Prevenar13. If your child does not respond to the medication or has seizures after vaccination, consult your doctor immediately. See also section 4.

Consult your doctor, pharmacist, or nurse before vaccination if your child was very premature (born at 28weeks or less of gestation), as the breathing interval may be longer than normal for 2 or 3 days after vaccination. See also section 4.

As with any vaccine, Prevenar13 will not protect all vaccinated individuals.

Prevenar13 will only protect against ear infections in children caused by the types ofStreptococcus pneumoniaefor which the vaccine has been developed. It will not protect against other infectious agents that may cause ear infections.

Use of Prevenar13 with other medications/vaccines

Your doctor may instruct you to give your child paracetamol or other medications that lower fever before administering Prevenar13. This will help reduce some of the adverse effects of Prevenar13.

Inform your doctor, pharmacist, or nurse if you or your child is using, has used recently, or may need to use other medications, even those obtained without a prescription, or has received another vaccine recently.

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 operating machinery

The influence of Prevenar13 on the ability to drive and operate machinery is negligible or insignificant. However, some of the effects mentioned in section4 “Possible adverse effects” may temporarily affect the ability to drive and operate machinery.

Prevenar13 contains sodium

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

The doctor or nursing staff will administer the recommended dose (0.5ml) of the vaccine into a muscle of your arm or your child's arm or leg.

Infants from 6weeks to 6months 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 administered from 6weeks of age.
• All injections must be administered separated by a minimum of one month.
• A fourth injection (booster) will be administered between 11 and 15months of age.
• You will be informed when to return with your child for the next injection.

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

Preterm infants

Your child will receive an initial series of three injections. The first injection can be administered 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 7months of age who have not been vaccinated

Infants from7 to 11monthsof age must receive two injections. The injections will be administered separated by a minimum of one month. A third injection will be administered in the second year of life.

Children from12 to 23monthsof age must receive two injections. The injections will be administered separated by a minimum of two months.

Children from2 to 17yearsof age must receive a single injection.

Infants, children, and adolescents previously vaccinated with Prevenar

Infants and children who have previously received Prevenar may receive Prevenar13 to complete the series of injections.

In the case of children from1 to 5yearsof age who have been previously vaccinated with Prevenar, your doctor or nursing staff will recommend how many injections ofPrevenar13are needed.

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

It is essential to follow the instructions of your doctor, pharmacist, or nursing staff so that your child completes the series of injections.

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

Adults

Adults must receive a single injection.

Inform your doctor, pharmacist, or nursing staff if you have previously received a pneumococcal vaccine.

If you have any other questions about the use of Prevenar13, ask your doctor, pharmacist, or nursing staff.

Special populations

People who may be at a higher risk of having pneumococcal infection (for example, those with sickle cell anemia or HIV infection), including those who have been previously vaccinated with one or more doses of the 23-valent pneumococcal polysaccharide vaccine, may receive at least one dose of Prevenar13.

People who have undergone a bone marrow transplant may receive three injections, the first of which is administered between 3 and 6months after the transplant and the subsequent doses with a minimum interval of one month between doses. It is recommended to administer a fourth dose (booster) 6months after the third injection.

Like all vaccines, Prevenar 13 may cause side effects, although not everyone will experience them.

Side effects observed with Prevenar 13 in infants and children (6 weeks to 5 years of age) include the following:

The most common side effects(those that may occur in more than 1 in 10 doses of the vaccine) are:

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

The common side effects(those that may occur in up to 1 in 10 doses administered of the vaccine) are:

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

The less common side effects(those that may occur in up to 1 in 100 doses of the vaccine) are:

• Convulsions (or seizures), including those caused by high fever.
• Hives (urticaria or rash similar to urticaria).
• Redness, swelling, or hardness of more than 7 cm at the injection site; crying.

The rare side effects(those that may occur in up to 1 in 1,000 doses of the vaccine) are:

• Collapse or a state similar to shock (hypotonic episode with hyporesponsiveness).
• Allergic reaction (hypersensitivity), including swelling of the face and/or lips, difficulty breathing.

Side effects observed with Prevenar 13 in children and adolescents (6 to 17 years of age) are as follows:

The most common side effects(those that may occur in more than 1 in 10 doses of the vaccine) are:

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

The common side effects(those that may occur in up to 1 in 10 doses of the vaccine) are:

• Headaches.
• Vomiting, diarrhea.
• Rash; hives (urticaria or rash similar to urticaria).
• Fever.

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

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

Following side effects have been observed with Prevenar 13 in adults:

The most common side effects(those that may occur in more than 1 in 10 doses of the vaccine) are:

• Decreased appetite; headaches; diarrhea; vomiting (in people aged 18 to 49 years).
• Chills; fatigue; skin rash; pain, redness, swelling, hardness, or tenderness at the injection site that interferes with arm movement (intense pain or tenderness at the injection site in people aged 18 to 39 years and significant limitation of arm movement very common in people aged 18 to 39 years).
• Worsening or new joint pain; worsening or new muscle pain.
• Fever (in people aged 18 to 29 years).

The common side effects(those that may occur in up to 1 in 10 doses of the vaccine) are:

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

The less common side effects(those that 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 presented similar side effects; however, the frequencies were very common for fever and vomiting, and common for nausea.

Adults who had undergone a bone marrow transplant presented similar side effects; however, the frequencies were very common for fever and vomiting.

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

• Severe allergic reaction, including cardiovascular collapse; angioedema (swelling of the lips, face, or throat).
• Rash, redness, and irritation of the skin (dermatitis) and itching (pruritus) at the injection site; flushing (flush).
• Enlargement of lymph nodes (lymphadenopathy) near the injection site, for example, 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 experience side effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this leaflet.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and on the label after EXP. The expiration date is the last day of the month indicated.

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

Do not freeze.

Prevenar13 is stable at temperatures up to 25°C for four days. After this time, Prevenar13 must be used or discarded. This information is intended to serve as a guide for healthcare professionals in the event of a cold chain break.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Prevenar Composition13

The active principles are conjugated polysaccharides with CRM197composed of:

• 2,2µg of polysaccharides of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F
• 4,4µg of polysaccharide of serotype6B

1dose (0.5ml) contains approximately 32µg of CRM197carrier protein adsorbed on aluminium phosphate (0.125mg of aluminium).

The other components are sodium chloride, succinic acid, polisorbate80 and water for injection.

Appearance of Prevenar13 and packaging content

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

Presentations of 1, 10and 50, with or without needle. Some packaging sizes may only be marketed.

Marketing Authorization Holder and Responsible Manufacturer

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

Spain

Pfizer, S.L.

Phone: +34 914909900

Last review date of this leaflet: 03/2024.

Other sources of information

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

-----------------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:

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

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

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

Administer the entire dose.

Prevenar13 is only for intramuscular administration. Do not administer by intravascular route.

Prevenar13 should not be mixed with any other vaccine in the same syringe.

Prevenar13 may be administered at the same time as other infant vaccines; in this case, different vaccination sites should be used.

Prevenar13 may be administered to adults aged 50 years or older at the same time as the trivalent or tetravalent inactivated influenza vaccine.

The disposal of unused medicinal product and of all materials that have been in contact with it, shall be in accordance with local requirements.