Bexsero
meningococcal group B Vaccine (rDNA, component, adsorbed)
Meningococcal group B Vaccine (rDNA, component, adsorbed)
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 get any side effects talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What Bexsero is and what it is used for
What you need to know before you or your child receive Bexsero
How to use Bexsero
Possible side effects
How to store Bexsero
Contents of the pack and other information
Bexsero is a Meningococcal group B Vaccine.
Bexsero contains four different components from the surface of the bacteria Neisseria meningitidis
group B.
Bexsero is given to individuals from 2 months of age and older to help protect against disease caused by the Neisseria meningitidis group B bacteria. These bacteria can cause serious, and sometimes
life-threatening, infections such as meningitis (inflammation of the covering of the brain and spinal cord) and sepsis (blood poisoning).
The vaccine works by specifically stimulating the body’s natural defense system of the vaccinated person. This results in protection against the disease.
if you or your child are allergic to the active substances or any of the other ingredients of this vaccine (listed in section 6).
Talk to your doctor or nurse before you or your child receive Bexsero:
if you or your child have a severe infection with a high temperature. If this is the case, then vaccination will be postponed. The presence of a minor infection, such as a cold, should not require postponement of the vaccination, but talk to your doctor or nurse first.
if you or your child have haemophilia or any other problem that may stop your blood from clotting properly, such as treatment with blood thinners (anticoagulants). Talk to your doctor or
nurse first.
if you or your child receive 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 remain at increased risk of disease caused by the Neisseria meningitidis group B bacteria.
if your child was born prematurely (before or at 28 weeks of pregnancy), particularly if they had breathing difficulties. Stopping breathing or irregular breathing for a short time may be more
common in the first three days following vaccination in these babies and they may need special
monitoring.
if you or your child have an allergy to the antibiotic kanamycin. If present, the kanamycin level in the vaccine is low. If you or your child may have an allergy to kanamycin, talk to your doctor or nurse first.
Fainting, feeling faint or other stress-related reactions can occur as a response to any needle injection. Tell your doctor or nurse if you have experienced this kind of reaction previously.
Tell your doctor or nurse if you know that you or your child is allergic to latex. The tip cap of the syringe may contain natural rubber latex. The risk for developing an allergic reaction is very small, but your doctor or nurse needs to be aware of your allergy when deciding if you or your child should receive Bexsero.
There are no data on the use of Bexsero in adults above 50 years of age. There are limited data on the use of Bexsero in patients with chronic medical conditions or with weakened immunity. If you or your child have weakened immunity (for example, due to the use of immunosuppressive medications, or HIV infection, or hereditary defects of the body’s natural defence system), it is possible that the effectiveness of Bexsero is reduced.
As with any vaccine, Bexsero may not fully protect all of those who are vaccinated.
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, whooping cough (pertussis), Haemophilus influenzae type b, polio, hepatitis B, pneumococcus, measles, mumps, rubella, chickenpox, and meningococcus A, C, W, Y. Talk to your doctor or nurse for further information.
When given at the same time with other vaccines Bexsero must be given at separate injection sites. Your doctor or nurse may ask you to give your child medicines that lower fever at the time and after
Bexsero has been given. This will help to reduce some of the side effects of Bexsero.
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 Bexsero is given. Your doctor may still recommend that you receive Bexsero if you are at risk of exposure to meningococcal infection.
Bexsero has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4 “Possible side effects” may temporarily affect the ability to drive or use machines.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free’.
Bexsero (0.5 ml) will be given to you or your child by a doctor or nurse. It will be injected into a muscle, usually the thigh for infants or the upper arm for children, adolescents and adults.
It is important to follow the instructions from the doctor or nurse so that you or your child completes the course of injections.
Your child should receive an initial course of two or three injections of the vaccine followed by an additional injection (booster).
The first injection should be given no earlier than 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 will be given between 12 months and 15 months of age after an interval of at least 6 months from the last injection of the initial course. In case of delay, the booster should not be
given later than 24 months of age.
Infants 6 months to 11 months of age should receive two injections of the vaccine followed by an additional injection (booster).
The interval between each injection should be at least 2 months.
A booster will be given in the second year of life after an interval of at least 2 months from the second injection.
Children 12 months to 23 months of age should receive two injections of the vaccine followed by an additional injection (booster).
The interval between each injection should be at least 2 months.
A booster will be given after an interval of 12 to 23 months from the second injection.
Children 2 years 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 an additional injection (booster).
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 an additional injection (booster).
There are no data in adults above 50 years of age. Ask your doctor for advice whether it is beneficial for you to receive Bexsero.
If you have any further questions on Bexsero, ask your doctor or nurse.
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 get (reported in all age groups) are:
pain/tenderness 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.
fever (≥ 38 °C)
loss of appetite
tenderness at the injection site (including severe injection site tenderness resulting in crying when injected limb is moved)
painful joints
skin rash (children aged 12 to 23 months) (uncommon after booster)
sleepiness
feeling irritable
unusual crying
vomiting (uncommon after booster)
diarrhoea
headache
skin rash (infants and children 2 to 10 years of age)
high fever (≥ 40 °C)
seizures (including febrile seizures)
dry skin
paleness (rare after booster)
Kawasaki disease which may include symptoms such as fever that lasts for more than five days, associated with a skin rash on the trunk of the body, and sometimes followed by a peeling of the
skin on the hands and fingers, swollen glands in the neck, red eyes, lips, throat and tongue
Itchy rash, skin rash
pain at the injection site resulting in inability to perform normal daily activity
painful muscles and joints
nausea
generally feeling unwell
headache
Side effects that have been reported during marketed use include: Enlarged lymph nodes.
Allergic reactions that may include severe swelling of the lips, mouth, throat (which may cause difficulty in swallowing), difficulty breathing with wheezing or coughing, rash, loss of consciousness
and very low blood pressure.
Collapse (sudden onset of muscle floppiness), less responsive than usual or lack of awareness, and paleness or bluish skin discoloration in young children.
Feeling faint or fainting.
Skin rash (adolescents from 11 years of age and adults). Fever (adolescents from 11 years of age and adults).
Injection site reactions like extensive swelling of the vaccinated limb, blisters at or around the injection site and hard lump at the injection site (which may persist for more than one month).
Neck stiffness or uncomfortable sensitivity to light (photophobia), indicating meningeal irritation, has
been sporadically reported shortly after vaccination; these symptoms have been of mild and transient nature.
If you get 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.
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 after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2 °C – 8 °C). Do not freeze.
Store in the original package in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your doctor or nurse how to throw away medicines you no longer use. These measures will help protect the environment.
One dose (0.5 ml) contains: Active substances:
Recombinant Neisseria meningitidis group B NHBA fusion protein 1, 2, 3 50 micrograms
Recombinant Neisseria meningitidis group B NadA protein 1, 2, 3 50 micrograms
Recombinant Neisseria meningitidis group B fHbp fusion protein 1, 2, 3 50 micrograms
Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254 measured as amount of total protein containing the PorA P1.4 2
25 micrograms
produced in E. coli cells by recombinant DNA technology
adsorbed on aluminium hydroxide (0.5 mg Al3+)
NHBA (Neisserial Heparin Binding Antigen), NadA (Neisseria adhesin A), fHbp (factor H binding protein)
Other ingredients:
Sodium chloride, histidine, sucrose and water for injections (see section 2 for further information on sodium and latex).
Bexsero is a suspension for injection in pre-filled syringe (Type I glass) with a plunger stopper (Type I bromobutyl rubber) and with a protective tip cap (Type I or Type II rubber) with or without needles.
Pack sizes of 1 or 10 syringes.
The suspension is white opalescent liquid.
Not all pack sizes may be marketed. Marketing Authorisation Holder: GSK Vaccines S.r.l.
Via Fiorentina 1
53100 Siena Italy.
GSK Vaccines S.r.l. Bellaria-Rosia
53018 Sovicille (Siena)
Italy.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
GSK Vaccines S.r.l. Tel: +370 80000334
GSK Vaccines S.r.l. Тел. +359 80018205
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
GSK Vaccines S.r.l. Tel: +356 80065004
GlaxoSmithKline GmbH & Co. KG Tel: +49 (0)89 36044 8701
GSK Vaccines S.r.l. Tel: +372 8002640
GlaxoSmithKline Μονοπρόσωπη A.E.B.E Tηλ: + 30 210 68 82 100
GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0
GSK Services Sp. z o.o. Tel.: + 48 (22) 576 9000
Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44
GlaxoSmithKline - Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
GSK Vaccines S.r.l. Tel.: +385 800787089
GSK Vaccines S.r.l. Tel: +40 800672524
GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 495 5000
GSK Vaccines S.r.l. Tel: +386 80688869
Vistor hf.
Sími: +354 535 7000
GlaxoSmithKline S.p.A. Tel: +39 (0)45 7741 111
GSK Vaccines S.r.l. Τηλ: +357 80070017
GSK Vaccines S.r.l. Tel: +371 80205045
Tel: +44(0)800 221441
This leaflet was last revised in {MM/YYYY}
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Upon storage a fine off-white deposit may be observed in the pre-filled syringe containing the suspension.
Before use, the pre-filled syringe should be well shaken in order to form a homogeneous suspension. The vaccine should be visually inspected for particulate matter and discoloration prior to
administration. In the event of any foreign particulate matter and/or variation of physical aspect being
observed, do not administer the vaccine. If two needles of different lengths are provided in the pack, choose the appropriate needle to ensure an intramuscular administration.
Do not freeze.
Bexsero must not be mixed with other vaccines in the same syringe.
Should concomitant administration of other vaccines be necessary, vaccines must be administered at separate injection sites.
Care must be taken to ensure that the vaccine is injected intramuscularly only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.