BEXSERO Injectable Suspension in Pre-filled Syringe

Introduction

Package Leaflet: Information for the User

Bexseroinjection suspension in pre-filled syringe

Meningococcal group B vaccine (rDNA, component, adsorbed)

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• This vaccine has been prescribed for you or your child only.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information:

1. What is Bexsero and what is it used for
2. What you need to know before you or your child receive Bexsero
3. How to use Bexsero
4. Possible side effects
5. Storage of Bexsero
6. Contents of the pack and further information

1. What is BEXSERO and what is it used for

Bexsero is a meningococcal group B vaccine.

Bexsero contains four different components from the surface of the bacterium Neisseria meningitidisgroup B.

Bexsero is given to individuals from 2 months of age to help protect them against diseases caused by the bacteria Neisseria meningitidisgroup B. These bacteria can cause serious infections which can sometimes be life-threatening, such as meningitis (inflammation of the membrane covering the brain and spinal cord) and sepsis (blood infection).

The vaccine works by specifically stimulating the body's natural defence system. This gives protection against the disease.

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

Do not use Bexsero

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

Warnings andprecautions

Talk to 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 talk to your doctor or nurse first.
• If you or your child have haemophilia or other problems that may affect blood clotting, such as treatment with blood thinners. Talk to your doctor or nurse first.
• If you or your child are receiving treatment that blocks 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 will still be at higher risk of invasive disease caused by the bacterium Neisseria meningitidisgroup B.
• If your child was born prematurely (at or before 28 weeks of gestation), especially if they had breathing difficulties. Stopping breathing or irregular breathing for a short period 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 kanamycin. If this is the case, the level of kanamycin in the vaccine is low. If you or your child may be allergic to kanamycin, talk to your doctor or nurse first.

Fainting, feeling of loss of consciousness or other stress-related reactions can occur in response to any needle injection. Tell your doctor or nurse if you have had such a reaction before.

There are no data on the use of Bexsero in adults over 50 years of age. Data on the use of Bexsero in patients with chronic medical conditions or with weakened immune systems are limited. If you or your child have a weakened immune system (for example, due to immunosuppressive drugs, HIV infection or congenital defects of the body's natural defence system), the effectiveness of Bexsero may be reduced.

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

Using Bexsero with other medicines

Tell your doctor or nurse if you or your child are taking, have recently taken or might take any other medicines or have recently received any other vaccine.

Bexsero can be given at the same time as any of the following vaccine components: diphtheria, tetanus, pertussis, Haemophilus influenzaetype b, poliomyelitis, hepatitis B, pneumococcal, measles, mumps, rubella, varicella and meningococcal A, C, W, Y. For more information, talk to your doctor or nurse.

When given at the same time as other vaccines, Bexsero should be administered in separate injection sites.

Your doctor or nurse may ask you to give your child medicines to reduce fever at the time of Bexsero administration and afterwards. This will help reduce the side effects of Bexsero.

Pregnancy andbreast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving Bexsero. Your doctor may still recommend that you receive Bexsero if you are at risk of exposure to meningococcal infection.

Driving andusing machines

Bexsero 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 or use machines.

Bexsero contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to use BEXSERO

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 important that you follow the doctor's or nurse's instructions to complete the series of injections.

Infants from 2 months up to5months of age at the time of the first dose

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

• The first injection should not be given before 2 months of age.
• If three initial doses are given, the interval between injections should be at least 1 month.
• If two initial doses are given, the interval between injections should be at least 2 months.
• A booster dose will be given between 12 and 15 months of age, after an interval of at least 6 months from the last injection of the initial series. If there is a delay, the booster dose should not be given later than 24 months of age.

Infants from6to11months of age at the time of the first dose

Infants from 6 to 11 months of age should receive two injections of the vaccine followed by a booster dose.

• The interval between each injection should be at least 2 months.
• A booster dose will be given in the second year of life, after an interval of at least 2 months from the second injection.

Children from12months to23months of age at the time of the first dose

Children from 12 to 23 months of age should receive two injections of the vaccine, followed by a booster dose.

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

Children from2to10years of age at the time of the first dose

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

• The interval between each injection should be at least 1 month.
• Your child may receive a booster dose.

Adolescents andadults from 11 years of age at the time of the first dose

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

• The interval between each injection should be at least 1 month.
• You may receive a booster dose.

Adults over50years of age

There are no data on adults over 50 years of age. Ask your doctor if Bexsero administration would be beneficial for you.

If you have any further questions on Bexsero, ask your doctor or nurse.

4. Possible side effects

Like all vaccines, this vaccine can cause side effects, although not everybody gets them.

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

• Pain/tenderness on pressure at the injection site, redness of the skin at the injection site, swelling of the skin at the injection site, hardness of the skin at the injection site.

The following side effects may also occur after receiving this vaccine.

Infants andchildren (up to10years of age)

Very common(may affect more than 1 in 10 people): fever (≥ 38 °C), loss of appetite, pain/tenderness on pressure at the injection site (including intense pain at the injection site causing crying when the injected limb is moved), painful joints, skin rash (children from 12 to 23 months of age) (uncommon after booster dose), sleepiness, irritability, unusual crying, vomiting (uncommon after booster dose), diarrhoea, headache.

Common(may affect up to 1 in 10 people): skin rash (infants and children from 2 to 10 years of age)

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

Rare(may affect up to 1 in 1,000 people): Kawasaki disease, which may include symptoms such as fever lasting more than five days, associated with 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. Itchy rash, skin rash

Adolescents (from11years of age) andadults

Very common(may affect more than 1 in 10 people): pain at the injection site that prevents normal daily activity, pain in muscles and joints, nausea, feeling unwell, headache.

Side effects reported during post-marketing use are:

Swollen lymph nodes.

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

Fainting (sudden loss of consciousness), reduced response to stimuli or loss of consciousness and paleness or bluish discolouration of the skin in young children.

Feeling of loss of consciousness or fainting.

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

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

Injection site reactions 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). Rarely, shortly after vaccination, stiffness of the neck or excessive sensitivity to light (photophobia) indicative of meningeal irritation have been reported; these symptoms have been mild and transient.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via 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 BEXSERO

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 pre-filled syringe after EXP. The expiry date is the last day of the month shown.

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

Store in the original package to protect from light.

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

6. Container contents and additional information

Bexsero composition

A dose (0.5 ml) contains:

Active ingredients

1 produced in E. colicells using recombinant DNA technology.

2 adsorbed on aluminum hydroxide (0.5 mg Al3+).

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

Other components:

Sodium chloride, histidine, sucrose, and water for injectable preparations (see section 2 for more information on sodium).

Appearance of the product andcontainer contents

Bexsero is a white opalescent suspension.

Bexsero is available in a pre-filled syringe with or without separate needles; package sizes of 1 and 10.

Only some package sizes may be marketed.

Marketing authorization holder:

GSK Vaccines S.r.l.

Via Fiorentina 1, 53100 Siena, Italy.

Manufacturer:

GSK Vaccines S.r.l.

Bellaria-Rosia, 53018 Sovicille (Siena), Italy.

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

Date of last revision of thisleaflet:

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

This information is intended solely forhealthcare professionals:

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

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

The vaccine should be inspected visually for particles or discoloration before administration.

If foreign particles and/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 it is necessary to administer it simultaneously with other vaccines, it should be done in separate injection sites.

Ensure that the vaccine is injected intramuscularly only.

Instructions for the pre-filled syringe

Disposal of waste

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