Prospect: information for the user

Bexseropre-filled syringe suspension

Meningococcal group B vaccine (ADNr, component, adsorbed)

Read this prospect carefully before you oryour child receive this medication, because it contains important information for you oryour child.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor ornurse.
• This vaccine has been prescribed only foryou oryour child.
• If you experience any adverse effects, consult your doctor ornurse, even if they are not listed in this prospect. See section4.

1.What is Bexsero andwhat is it used for

2.What you need to know before you oryour child receive Bexsero

3.How to use Bexsero

4.Possible adverse effects

5.Storage of Bexsero

6.Contents of the package andadditional information

Bexsero is ameningococcal vaccine group B.

Bexsero contains four different components of the surface of the bacteriaNeisseria meningitidisgroup B.

Bexsero is administered toindividuals from2months of age to help themprotect themselves againstdiseases caused by the bacteriaNeisseria meningitidisgroup B. These bacteria can cause serious infections that, at times, can be fatal, such as meningitis (inflammation of the membrane that covers the brain andthe spinal cord) andsepsis (generalized infection of the blood).

The vaccine works by specifically stimulating the natural defense system of the body of the vaccinated person. This produces a protection againstthe disease.

Do not use Bexsero

• If you or your child are allergic to the active ingredients or any of the other components of this vaccine (listed in section 6).

Warnings and precautions

Consult your doctor or nurse before you or your child receive Bexsero:

• If you or your child have a severe infection with high fever. In this case, vaccination will be postponed. The presence of a minor infection, such as a cold, is not a reason to postpone vaccination, but consult your doctor or nurse first.
• If you or your child have hemophilia or other conditions that may affect blood clotting, such as anticoagulant treatment. Consult your doctor or nurse first.
• If you or your child are receiving treatment that blocks the part of the immune system known as complement activation, such as eculizumab. Even if you or your child have been vaccinated with Bexsero, you or your child still have a higher risk of invasive disease caused by the bacterium Neisseria meningitidis group B.
• If your child was born prematurely (at 28 weeks of gestation or earlier), especially if they had breathing difficulties. Stopping breathing or breathing irregularly for a short period of time may be more common in the first three days after vaccination in these babies and may require special monitoring.
• If you or your child are allergic to the antibiotic kanamicin. If you or your child have an allergy to kanamicin, consult your doctor or nurse first.

You may experience dizziness, feeling of loss of consciousness, or other reactions associated with stress as a response to any injection with a needle. Inform your doctor or nurse if you have had a reaction of this type in the past.

There are no data on the use of Bexsero in adults over 50 years of age. The data on the use of Bexsero in patients with chronic medical conditions or a weakened immune system are limited. If you or your child have a weakened immune system (for example, due to immunosuppressive drugs, HIV infection, or congenital defects in the body's natural defense system), it is possible that the efficacy of Bexsero will be reduced.

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

Use of Bexsero with other medicines

Inform your doctor or nurse if you or your child are taking, have taken recently, or may need to take any other medicine or have received any other vaccine recently.

Bexsero can be administered at the same time as any of the following vaccine components: diphtheria, tetanus, pertussis, Haemophilus influenzae type b, poliomyelitis, hepatitis B, pneumococcus, measles, mumps, rubella, varicella, and meningococci A, C, W, Y. For more information, consult your doctor or nurse.

When administered simultaneously with other vaccines, Bexsero must be administered in separate injection sites.

Your doctor or nurse may ask you to administer medication to your child that reduces fever at the time of administering Bexsero and afterwards. This will help reduce the adverse effects of Bexsero.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor before Bexsero is administered. Your doctor may still recommend administering Bexsero if you have a risk of exposure to meningococcal infection.

Driving and use of machines

The influence of Bexsero on the ability to drive and use machines is negligible or insignificant. However, some of the effects mentioned in section 4 “Possible adverse effects” may temporarily affect the ability to drive or use machines.

Bexsero contains sodium chloride

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially “sodium-free”.

Bexsero (0.5 ml) will be administered to you or your child by a doctor or nurse. It will be injected into a muscle, usually in the thigh in infants or in the upper arm in children, adolescents, and adults.

It is essential to follow the doctor's or nurse's instructions to complete the series of injections.

Infants from 2 months to 5 months of age at the time of the first dose

Your child must receive an initial series of two or three injections of the vaccine followed by an additional injection (booster dose).

• The first injection must not be administered before 2 months of age.
• If three initial doses are administered, the interval between injections must be at least 1 month.
• If two initial doses are administered, the interval between injections must be at least 2 months.
• A booster dose will be administered between 12 and 15 months of age after an interval of at least 6 months since the last injection of the initial series. In case of delay in administration, the booster dose must not be administered later than 24 months of age.

Infants from 6 to 11 months of age at the time of the first dose

Infants from 6 to 11 months of age must receive two injections of the vaccine followed by an additional injection (booster dose).

• The interval between each injection must be at least 2 months.
• A booster dose will be administered in the second year of life after an interval of at least 2 months since the second injection.

Children from 12 months to 23 months of age at the time of the first dose

Children from 12 to 23 months of age must receive two injections of the vaccine, followed by an additional injection (booster dose).

• The interval between each injection must be at least 2 months.
• A booster dose will be administered after an interval of 12 to 23 months since the second injection.

Children from 2 to 10 years of age at the time of the first dose

Children from 2 to 10 years of age must receive two injections of the vaccine.

• The interval between each injection must be at least 1 month.
• Your child may receive an additional injection (booster).

Adolescents and adults from 11 years of age at the time of the first dose

Adolescents (from 11 years of age) and adults must receive two injections of the vaccine.

• The interval between each injection must be at least 1 month.
• You may receive an additional injection (booster).

Adults over 50 years

There are no data on adults over 50 years. Ask your doctor if it would be beneficial for you to receive Bexsero.

If you have any other questions about Bexsero, ask your doctor or nurse.

Like all vaccines, this vaccine can cause side effects, although not everyone will experience them.

When Bexsero is administered to you or your child, the very common side effects (which can affect more than 1 in 10 people) that you or your child may experience are (observed in all age groups):

• Pain or sharp pain at the injection site, redness of the skin at the injection site, swelling of the skin at the injection site, hardening of the skin at the injection site.

After receiving this vaccine, the following side effects may also occur.

Infants and children (up to 10 years of age)

Very common (can affect more than 1 in 10 people): fever (≥ 38°C), loss of appetite, acute pain at the injection site (including intense pain at the injection site that causes crying when moving the limb in which the injection was administered), joint pain, skin rash (children aged 12 to 23 months) (rare after the booster dose), drowsiness, irritability, unusual crying, vomiting (rare after the booster dose), diarrhea, headache.

Common (can affect up to 1 in 10 people): skin rash (infants and children aged 2 to 10 years)

Rare (can affect up to 1 in 100 people): high fever (≥ 40°C), convulsions (including febrile convulsions), dry skin, paleness (rare after the booster dose)

Very rare (can affect up to 1 in 1,000 people): Kawasaki disease, which may include symptoms such as fever lasting more than five days, associated with a skin rash on the trunk, and sometimes followed by peeling of the skin on hands and fingers, swollen lymph nodes in the neck, and redness of the eyes, lips, throat, and tongue. Itching rash, skin rash

Adolescents (from 11 years of age) and adults

Very common (can affect more than 1 in 10 people): pain at the injection site that prevents normal daily activity, muscle and joint pain, nausea, general malaise, headache.

The side effects reported during commercial use are:

Enlarged lymph nodes.

Allergic reactions, which may include intense swelling of the lips, mouth, and throat (which may cause difficulty swallowing), difficulty breathing with wheezing (whistling when breathing) or coughing, rash, loss of consciousness, and very low blood pressure.

Collapsing (sudden flaccidity of muscles), or reduced response level or loss of consciousness and paleness or bluish discoloration of the skin in young children.

Sensation of loss of consciousness or dizziness.

Skin rash (adolescents from 11 years of age and adults).

Fever (adolescents from 11 years of age and adults).

Reactions at the injection site such as extensive swelling of the vaccinated limb, blisters at the injection site or in the surrounding area, and hard lump at the injection site (which may last more than a month). Sporadically, rigidity of the neck or excessive sensitivity to light (photophobia) indicative of meningeal irritation have been reported, these symptoms have been of a mild and transient nature.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through the national 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 pre-filled syringe label after CAD. The expiration date is the last day of the month indicated.

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

Store in the original packaging to protect it from light.

Medicines should not be disposed of through drains or in the trash. Ask your doctor or nurse how to dispose of the containers and medicines that you no longer need. By doing so, you will help protect the environment.

Composition of Bexsero

A dose (0.5ml) contains:

Active principles

Produced inE. colicells using recombinant DNA technology.

Adsorbed on aluminum hydroxide (0.5mg Al3+).

3contains NHBA (Neisseria heparin-binding antigen), NadA (Neisseria adhesin A), and fHbp (factor H-binding protein)

The other components:

Sodium chloride, histidine, sucrose, andwater for injection (see section2for more information on sodium).

Appearance of the product andcontents of the package

Bexsero is awhite opalescent suspension.

Bexsero is available in pre-filled syringe of 1 dose with orwithout separate needles; package sizesof1and10.

Only some package sizes may be marketed.

Marketing authorization holder:

GSK Vaccines S.r.l.

Via Fiorentina1
53100Siena
Italy.

Responsible for manufacturing:

GSK Vaccines S.r.l.

Bellaria‑Rosia
53018Sovicille (Siena)
Italy.

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

Last update of thisleaflet:

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

This information is intended solelyforhealthcare professionals:

During storage, a fine white deposit may be observed in the suspension of thepre-filled syringe.

Shake the vaccine well before use to form a homogeneous suspension.

The vaccine should be visually inspected for particles ordiscoloration before administration.

If particles or alteration of the physical appearance are observed, do not administer the vaccine. If the package contains two needles of different lengths, choose the most suitable one to ensure that the vaccine can be administered intramuscularly.

Do not freeze.

Bexsero should not be mixed with other vaccines in the same syringe.

If simultaneous administration with other vaccines is necessary, it should be done in separate injection sites.

Ensure that the vaccine is injected only intramuscularly.

Instructions for the pre-filled syringe

Disposal of residues

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