Bexsero

Package leaflet: Information for the user

Bexsero injectable suspension in prefilled syringe

Meningococcal group B vaccine (rDNA, component, adsorbed)
Please read all of this leaflet carefully before you or your child is given 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 questions, ask your doctor or nurse.
• This vaccine has been prescribed only for you or your child.
• If you notice any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What BEXSERO is and what it is used for

Bexsero is a vaccine against group B meningococcus.
Bexsero contains four different components from the surface of Neisseria meningitidis group B bacteria.
Bexsero is given to individuals aged 2 months and older to help protect them against disease caused by Neisseria meningitidis group B bacteria. These bacteria can cause serious, sometimes life-threatening infections, such as meningitis (inflammation of the membranes covering the brain and spinal cord) and sepsis (blood infection).
The vaccine works by specifically stimulating the natural defence system of the vaccinated person's body, thereby protecting them against the disease.

2. What you should know before you or your child receive BEXSERO

DO NOT use Bexsero

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

Warnings and precautions
Talk to your doctor or nurse before you or your child receive Bexsero:

• if you or your child have a serious infection with high fever. In this case, vaccination will be postponed. A mild infection, such as a cold, should not delay vaccination, but inform your doctor or nurse beforehand.
• if you or your child have haemophilia or other conditions that may prevent blood from clotting properly, such as treatment with medicines that reduce blood clotting (anticoagulants). Inform your doctor or nurse beforehand.
• 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, there remains an increased risk of disease caused by Neisseria meningitidis group B bacteria.
• if the child was born prematurely (before or at 28 weeks of gestation), especially if they experienced breathing difficulties. In these newborns, breathing interruptions or irregular breathing for a short period may be more common during the first three days after vaccination and may require special monitoring.
• if you or your child are allergic to the antibiotic kanamycin. The level of kanamycin, if present in the vaccine, is low. Consult your doctor or nurse beforehand if you or your child may be allergic to kanamycin.

Fainting, feeling faint, or other stress-related reactions may occur in response to any needle injection. Talk to your doctor or nurse if you have previously experienced such reactions.
There are no data available on the use of Bexsero in adults over 50 years of age. Data on the use of Bexsero in individuals with chronic medical conditions or with a weakened immune system are limited. The effectiveness of Bexsero may be reduced if you or your child have a weakened immune system (for example, due to the use of immunosuppressive medicines, HIV infection, or inherited defects in the body's natural defence system).
Like all vaccines, Bexsero may not protect every vaccinated individual completely.
Other medicines and Bexsero
Inform your doctor or nurse if you or your child are taking, have recently taken, or might take any other medicines, or if you or your child have recently received any other vaccination.
Bexsero can be administered simultaneously with each of the components of the following vaccines: diphtheria, tetanus, pertussis, Haemophilus influenzae type b, poliomyelitis, hepatitis B, pneumococcus, measles, mumps, rubella, varicella, and meningococcus A, C, W, Y. For further information, consult your doctor or nurse.
If administered at the same time as other vaccines, Bexsero must be given at a different injection site.
Your doctor or nurse may recommend giving your child medicines to reduce fever when Bexsero is administered or immediately afterwards. This helps reduce some of the undesirable effects of Bexsero.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before receiving Bexsero vaccination.
If you are at risk of exposure to meningococcal infection, your doctor may still recommend vaccination with Bexsero.
Driving and using machines
Bexsero does not affect or affects negligibly the ability to drive or 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 chloride
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e., essentially “sodium-free”.

3. How to use BEXSERO

Bexsero (0.5 mL) will be administered to you or to the child by a doctor or nurse. It will be injected into a muscle, usually into the thigh for children up to 2 years of age, or into the upper arm for older children, adolescents, and adults.
It is important to follow the doctor's or nurse's instructions to complete the vaccination course for you or for the child.

Infants aged 2 to 5 months at the time of the first dose
The child should receive a primary course of two or three vaccine injections, followed by an additional (booster) injection.

• The first injection should be given no earlier than 2 months of age.
• If three primary doses are administered, the interval between injections should be at least 1 month.
• If two primary doses are administered, the interval between injections should be at least 2 months.
• A booster dose should be given between 12 and 15 months of age, at least 6 months after the last injection of the primary course. If delayed, the booster dose should be administered by 24 months of age.

Infants aged 6 to 11 months at the time of the first dose
Children aged 6 to 11 months should receive two vaccine injections, followed by an additional (booster) injection.

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

Children aged 12 to 23 months at the time of the first dose
Children aged 12 to 23 months should receive two vaccine injections, followed by an additional (booster) injection.

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

Children aged 2 to 10 years at the time of the first dose
Children aged 2 to 10 years should receive two vaccine injections.

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

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

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

Adults over 50 years of age
Data are not available for adults over 50 years of age. Please consult your doctor for advice on the benefits of vaccination in your specific case.
If you have any further questions about Bexsero, please consult your doctor or nurse.

4. Possible side effects

Like all vaccines, this vaccine may cause side effects, although not everyone experiences them.
When Bexsero is administered to you or your child, the following very common side effects (occurring in all age groups) may occur:
Pain/tenderness at the injection site, redness, swelling and hardening of the skin at the injection site.
After receiving the vaccine, the following side effects may also occur.

Children up to 10 years of age
Very common (may affect more than 1 in 10 people): fever (temperature equal to or greater than 38 °C), loss of appetite, tenderness at the injection site (including severe tenderness causing crying when the injected limb is moved), joint pain, rash (children aged 12 to 23 months) (uncommon after booster vaccination), sleepiness, irritability, unusual crying, vomiting (uncommon after booster dose), diarrhoea, headache.
Common (may affect up to 1 in 10 people): rash (children aged 2 to 10 years).
Uncommon (may affect up to 1 in 100 people): high fever (temperature equal to or greater than 40 °C), convulsions (including febrile convulsions), dry skin, pallor (rarely 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 5 days, associated with rash on the trunk and sometimes followed by skin peeling on the hands and fingers, swollen glands in the neck, redness of the eyes, lips, throat and tongue. Itchy rash, rash.

Adolescents (aged 11 years and older) and adults
Very common (may affect more than 1 in 10 people): pain at the injection site causing inability to perform normal daily activities, painful muscles and joints, nausea, general feeling of being unwell, headache.

Side effects reported after marketing of the medicinal product include:
Swollen lymph nodes.
Allergic reactions which may include severe swelling of lips, mouth, throat (with possible difficulty swallowing), difficulty breathing with wheezing or coughing, rash, loss of consciousness and very low blood pressure.
Collapse (sudden floppiness), reduced responsiveness compared to usual or loss of consciousness, pallor or bluish discolouration of the skin in young children.
Feeling faint or fainting.
Rash (adolescents aged 11 years and older and adults).
Fever (adolescents aged 11 years and older and adults).
Reactions at the injection site such as extensive swelling of the vaccinated limb, blisters at or around the injection site and hardening of the injection site (which may persist for more than one month).
Neck stiffness or sensitivity to light (photophobia), indicating irritation of the meninges, have been reported occasionally shortly after vaccination; these symptoms were mild and transient.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to store BEXSERO

Keep this vaccine out of the sight and reach of children.
Do not use this vaccine after the expiry date stated on the carton and on the label of the pre-filled syringe following Exp. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Keep in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your doctor or nurse how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Bexsero contains
One dose (0.5 mL) contains:
Active substances:
Recombinant fusion protein NHBA from Neisseria meningitidis group B 50 micrograms
Recombinant protein NadA from Neisseria meningitidis group B 50 micrograms
Recombinant fusion protein fHbp from Neisseria meningitidis group B 50 micrograms
Outer membrane vesicles (OMV) from Neisseria meningitidis group B 25 micrograms
strain NZ98/254, measured as total protein content containing PorA P1.4
produced in E. coli cells using recombinant DNA technology
adsorbed onto aluminium hydroxide (0.5 mg Al)
NHBA (Neisserial Heparin Binding Antigen), NadA (Neisseria adhesin A),
fHbp (factor H binding protein)
Other components:
Sodium chloride, histidine, sucrose and water for injections (for further information on
sodium, see section 2).

Description of the appearance of Bexsero and package contents
Bexsero is a white, opalescent suspension.
Bexsero is available in pre-filled syringes of 1 dose, with or without separate needles, in packs of 1 and 10 syringes.
Not all pack sizes may be marketed.

Marketing Authorisation 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 further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals SA/NV GSK Vaccines S.r.l.
Tél/Tel: + 32 10 85 52 00 Tel: +370 80000334

България Luxembourg/Luxemburg
GSK Vaccines S.r.l. GlaxoSmithKline Pharmaceuticals SA/NV
Тел. +359 80018205 Tél/Tel: + 32 10 85 52 00

Česká republika Magyarország
GlaxoSmithKline s.r.o. GSK Vaccines S.r.l.
Tel: + 420 2 22 00 11 11 Tel.: +36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GSK Vaccines S.r.l.
Tlf: + 45 36 35 91 00 Tel: +356 80065004
[email protected]

Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel: +49 (0)89 36044 8701 Tel: + 31 (0)33 2081100
[email protected]

Eesti Norge
GSK Vaccines S.r.l. GlaxoSmithKline AS
Tel: +372 8002640 Tlf: + 47 22 70 20 00

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E GlaxoSmithKline Pharma GmbH
Tηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (22) 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline GlaxoSmithKline - Produtos Farmacêuticos,
Tél: + 33 (0) 1 39 17 84 44 Lda.
[email protected] Tel: + 351 21 412 95 00
[email protected]

Hrvatska România
GSK Vaccines S.r.l. GSK Vaccines S.r.l.
Tel.: +385 800787089 Tel: +40 800672524

Ireland Slovenija
GlaxoSmithKline (Ireland) Ltd GSK Vaccines S.r.l.
Tel: + 353 (0)1 495 5000 Tel.: +386 80688869

Ísland Slovenská republika
Vistor hf. GSK Vaccines S.r.l.
Sími: +354 535 7000 Tel: +421 800500589

Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: +39 (0)45 7741111 Puh/Tel: + 358 10 30 30 30

Κύπρος Sverige
GSK Vaccines S.r.l. GlaxoSmithKline AB
Τηλ: +357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija United Kingdom (Northern Ireland)
GSK Vaccines S.r.l. GSK Vaccines S.r.l.
Tel: +371 80205045 Tel: +44 (0)800 221 441
[email protected]

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

The following information is intended exclusively for healthcare professionals:

During storage, formation of a fine whitish deposit may be observed in the prefilled syringes containing the suspension.
Before use, shake the prefilled syringe thoroughly to form a homogeneous suspension.
Before administration, the vaccine should be inspected visually for the presence of foreign particulate matter or discoloration. Do not administer the vaccine if foreign particulate matter and/or physical changes in appearance are observed. If two needles of different lengths are provided in the package, select the needle appropriate to ensure intramuscular administration.
Do not freeze.
Bexsero must not be mixed with other vaccines in the same syringe.
If co-administration with other vaccines is necessary, the vaccines must be administered at different injection sites.
Take care to ensure that the vaccine is injected exclusively by the intramuscular route.

Instructions for the prefilled syringe

Hold the syringe by the barrel, not by the plunger.
Unscrew the syringe cap by turning it counterclockwise.

To attach the needle to the syringe, gently connect the needle hub to the Luer Lock adapter and rotate one-quarter turn clockwise until a click is felt, indicating secure attachment.
Do not pull the plunger out of the syringe barrel. If this occurs, do not administer the vaccine.

Disposal
Any unused medicinal product and waste material derived from it must be disposed of in accordance with local regulations.