BEXSERO 0.5ML Injectable suspension in pre-filled syringe

Зміст інструкції

1. Bexsero injectable suspension in pre-filled syringe
   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. How to store BEXSERO
   6. Package contents and other information

Bexsero injectable suspension in pre-filled syringe

Vaccine against Meningococcus group B (recombinant DNA, component, adsorbed)

Read 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 questions, ask your doctor or nurse.
• This vaccine has been prescribed only for you or your child.
• If any side effects occur, including those not listed in this leaflet, ask 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 receive 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 is BEXSERO and what is it used for

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

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

DO NOT use Bexsero

• if you or your child is allergic to the active ingredients 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 has a serious infection with a high temperature. In this case, vaccination will be postponed. The presence of a mild infection, such as a cold, should not lead to postponement of vaccination, but inform your doctor or nurse beforehand.
• if you or your child has 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 is receiving treatment that blocks part of the immune system known as complement activation, such as eculizumab. Even if you or your child has been vaccinated with Bexsero, you remain at higher risk of illness caused by bacteria of Neisseria meningitidisgroup B.
• if the child was born prematurely (before or at 28 weeks of pregnancy), especially if they have had breathing difficulties. In these newborns, in the first three days after vaccination, interruptions of breathing or irregular breathing for a short period may be more common and may require special monitoring.
• if you or your child has an allergy to the antibiotic kanamycin. The level of kanamycin, if present in the vaccine, is low. Talk to your doctor or nurse before if you or your child may be allergic to kanamycin.

Fainting, feeling faint, or other stress-related reactions may occur in response to any injection. Talk to your doctor or nurse if you have had these types of reactions previously.
There are no data available on the use of Bexsero in adults over 50 years of age. Data on the use of
Bexsero in subjects with chronic medical conditions or with a weakened immune system are
limited. It is possible that the effectiveness of Bexsero may be reduced if you or your child has a
weakened immune system (due, for example, to the use of immunosuppressant medicines or the presence
of HIV infection or hereditary defects of the body's natural defense system).
Like all vaccines, Bexsero may not fully protect all vaccinated individuals.

Other medicines and Bexsero
Tell your doctor or nurse if you, or your child, are taking, have recently taken
or may take any other medicine or have recently had any other
vaccination.
Bexsero can be given at the same time as any of the components of the following
vaccines: diphtheria, tetanus, pertussis, Haemophilus influenzaetype b, poliomyelitis, hepatitis B,
pneumococcus, measles, mumps, rubella, varicella and meningococcal A, C, W, Y. For more
information, consult your doctor or nurse.
If given at the same time as other vaccines, Bexsero should be given in
a different injection site.
Your doctor or nurse may ask you to give the child medicine to lower the fever
when Bexsero is given or shortly after. This helps to reduce some side
effects of Bexsero.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding
with breast milk, ask your doctor for advice before being vaccinated with Bexsero.
If you are at risk of exposure to meningococcal infection, your doctor may still recommend
that you be vaccinated with Bexsero.

Driving and using machines
Bexsero does not or negligibly alters the ability to drive vehicles or use machines.
However, some of the effects mentioned in section 4 “Possible side effects” may
temporarily affect the ability to drive vehicles 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 the doctor or nurse. It will be injected into
a muscle, usually in the thigh in children up to 2 years of age or in the upper arm
in older children, adolescents and adults.
It is important to follow the doctor's or nurse's instructions for completing the cycle of
injections for you, or for the child.

Children aged between 2 and 5 months at the time of the first dose
The child must receive an initial cycle of two or three injections of the vaccine followed by an additional (booster) injection.

• The first injection must be administered no earlier than 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 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 cycle. If delayed, the booster dose must be administered within 24 months of age.

Children aged between 6 and 11 months at the time of the first dose
Children aged between 6 and 11 months must receive two injections of the vaccine followed by an
additional (booster) injection.

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

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

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

Children aged between 2 and 10 years at the time of the first dose
Children aged between 2 and 10 years must receive two injections of the vaccine.

• The interval between each administration must be at least 1 month. Your child may be given a further (booster) injection.

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

• The interval between each administration must be at least 1 month. You may be given a further (booster) injection.

Adults over 50 years of age
There are no data available regarding adults over 50 years of age. Ask your doctor for
advice on the benefits of vaccination in your specific case.
If you have any further need for information on Bexsero, ask your doctor or nurse.

4. Possible side effects

Like all vaccines, this vaccine can cause side effects, although not everyone will experience them.
When Bexsero is administered to you or your child, very common side effects (may affect more than 1 in 10 people) that may occur are (reported in all age groups):
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 that causes crying when the limb where the injection was given is moved), joint pain, rash (children aged between 12 and 23 months) (uncommon after the booster vaccination), drowsiness, irritability, unusual crying, vomiting (uncommon after the booster dose), diarrhea, headache.

Common(may affect up to 1 in 10 people): rash (children from 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, paleness (rarely after the booster dose).

Rare(may affect up to 1 in 1,000): Kawasaki disease, which may include symptoms such as fever lasting more than 5 days, associated with a rash on the trunk and sometimes followed by peeling of the skin on the hands and fingers, swelling of the 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, sore muscles and joints, nausea, general feeling of being unwell, headache.
Side effects reported after the medicinal product has been marketed include:
Swollen lymph nodes.
Allergic reactions that 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 muscle weakness), decreased responsiveness compared to usual or loss of consciousness, paleness or bluish discoloration of the skin in young children.
Feeling faint or fainting.
Rash (adolescents from 11 years and adults)
Fever (adolescents from 11 years 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 a month).
Stiff neck or sensitivity to light (photophobia), which indicates irritation of the meninges, have been sporadically reported shortly after vaccination; these symptoms have been mild and transient.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please tell 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 medicine.

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 that is stated on the pack and on the label of the
pre-filled syringe after Exp. The expiry date refers to the last day of the month indicated.
Store in a refrigerator (2 ° C – 8 ° C). Do not freeze.
Store in the original package to protect the medicine from light.
Do not dispose of any medicine in 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 ingredients:
Recombinant fusion protein NHBA of Neisseria meningitidisgroup B 50 micrograms
Recombinant protein NadA of Neisseria meningitidisgroup B 50 micrograms
Recombinant fusion protein fHbp of Neisseria meningitidisgroup B 50 micrograms
Outer membrane vesicles (OMV) of Neisseria meningitidisgroup B
strain NZ98/254 measured as total protein amount containing PorA
P1.4
25 micrograms
produced on E. colicells using recombinant DNA technology
adsorbed on aluminum 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 paragraph 2).

Description of Bexsero and package contents
Bexsero is an opalescent white suspension.
Bexsero is available in pre-filled 1-dose syringes with or without separate needles, 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, contact the local representative of the Marketing
Authorisation Holder:

België/Belgique/Belgien
GlaxoSmithKline Pharmaceuticals SA/NV
Tél/Tel: + 32 10 85 52 00

Lietuva
GSK Vaccines S.r.l.
Tel: +370 80000334

България
GSK Vaccines S.r.l.
Тел. +359 80018205

Luxembourg/Luxemburg
GlaxoSmithKline Pharmaceuticals SA/NV
Tél/Tel: + 32 10 85 52 00

Česká republika
GlaxoSmithKline s.r.o.
Tel: + 420 2 22 00 11 11
[email protected]

Magyarország
GSK Vaccines S.r.l.
Tel.: +36 80088309

Danmark
GlaxoSmithKline Pharma A/S
Tlf: + 45 36 35 91 00
[email protected]

Malta
GSK Vaccines S.r.l.
Tel: +356 80065004

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

Nederland
GlaxoSmithKline BV
Tel: + 31 (0)33 2081100

Eesti
GSK Vaccines S.r.l.
Tel: +372 8002640

Norge
GlaxoSmithKline AS
Tlf: + 47 22 70 20 00

Ελλάδα
GlaxoSmithKline Μονοπρόσωπη A.E.B.E
Τηλ: + 30 210 68 82 100

Österreich
GlaxoSmithKline Pharma GmbH
Tel: + 43 (0)1 97075 0
[email protected]

España
GlaxoSmithKline, S.A.
Tel: + 34 900 202 700
[email protected]

Polska
GSK Services Sp. z o.o.
Tel.: + 48 (22) 576 9000

France
Laboratoire GlaxoSmithKline
Tél: + 33 (0) 1 39 17 84 44

Portugal
GlaxoSmithKline - Produtos Farmacêuticos,
Lda.
[email protected] Tel: + 351 21 412 95 00
[email protected]

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

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

Ireland
GlaxoSmithKline (Ireland) Ltd
Tel: + 353 (0)1 495 5000

Slovenija
GSK Vaccines S.r.l.
Tel.: +386 80688869

Ísland
Vistor hf.
Sími: +354 535 7000

Slovenská republika
GSK Vaccines S.r.l.
Tel: +421 800500589

Italia
GlaxoSmithKline S.p.A.
Tel: +39 (0)45 7741111

Suomi/Finland
GlaxoSmithKline Oy
Puh/Tel: + 358 10 30 30 30

Κύπρος
GSK Vaccines S.r.l.
Τηλ: +357 80070017

Sverige
GlaxoSmithKline AB
Tel: + 46 (0)8 638 93 00
[email protected]

Latvija
GSK Vaccines S.r.l.
Tel: +371 80205045

United Kingdom (Northern Ireland)
GSK Vaccines S.r.l.
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 for healthcare professionals only:
During storage, the formation of a fine whitish deposit may be observed in the pre-filled syringes
containing the suspension.
Shake the pre-filled syringe thoroughly before use to form a homogeneous suspension.
Before administration, the vaccine must be visually inspected for the presence of any foreign particulate
matter or changes in color. Do not administer the vaccine if foreign particulate matter and/or changes in
appearance are observed. If two needles of different lengths are provided in the package, choose the
needle suitable to ensure intramuscular administration.
Do not freeze.
Bexsero must not be mixed with other vaccines in the same syringe.
If co-administration of other vaccines is necessary, the vaccines must be administered at different injection
sites.
Take care to ensure that the vaccine is injected intramuscularly only.
Instructions for the pre-filled syringe

Hold the syringe by the body, not by the plunger.

Unscrew the syringe cap by rotating counterclockwise.

To attach the needle to the syringe, gently connect the
needle hub to the Luer Lock Adapter and rotate a
quarter turn clockwise until a click is felt.

Do not pull the syringe plunger out of the body. If this
happens, do not administer the vaccine.
Disposal
Unused medicinal product and waste materials must be disposed of in accordance with
local regulations.