Solution for injection in a pre-filled syringe 
Meningococcal group B vaccine (rDNA, component, adsorbed )

Read all of this leaflet carefully before you or your child start using this medicine. It contains information that is important to you or your child.

– Save this information, 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 also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What BEXSERO is and what it is used for 
2. What you need to know before you or your child use BEXSERO 
3. How to use BEXSERO 
4. Possible side effects 
5. How to store BEXSERO 
6. Packaging content and other information 

1. What BEXSERO is and what it is used for

Bexsero is a meningococcal group B vaccine.

Bexsero contains four different recombinant proteins and components from the surface of the bacterium Neisseria meningitides group B.

Bexsero is given to people from 2 months of age and helps to protect against diseases caused by the bacterium Neisseria meningitides group B. This bacterium can cause serious and sometimes life-threatening infections such as. meningitis ( inflammation of the membranes of the brain and spinal cord) and sepsis (blood poisoning).

The vaccine works by stimulating the body’s natural defense system in a specific way in the vaccinated person. This leads to protection against the disease.

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

DO NOT use Bexsero

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

Warnings and cautions

Talk to your doctor or nurse before using Bexsero

  • if you or your child have a severe infection with a high fever. In that case, the vaccination will be postponed. The presence of a minor infection , e.g. cold, should not cause the vaccination to be postponed but talk to a doctor or nurse first.
  • if you or your child have hemophilia or any other problem that could prevent the blood from coagulating properly, e.g. treatment with blood thinners ( anticoagulants ). Talk to a doctor or nurse first.
  • if you or your child are receiving treatment that inhibits the part of the immune system called complement activation, such as with eculizumab. Even if you or your child have been vaccinated with Bexsero, you or your child will have a continuing increased risk of developing a disease caused by Neisseria meningitides group B bacteria.
  • if your baby was born prematurely (before or during week 28 of pregnancy), especially if it had difficulty breathing. A respiratory arrest or irregular breathing for a short time may be more common in these children during the first three days after vaccination and they may need special monitoring.
  • if you or your child have an allergy to kanamycin ( antibiotics ). If present, the level of kanamycin in the vaccine is low. If you or your child are allergic to kanamycin, talk to a doctor or nurse first.

Fainting, fainting, or other stress-related reactions may occur as a reaction to needle sticking. Tell your doctor or nurse if you have experienced this type of reaction before.

Tell your doctor or nurse if you or your child are allergic to latex. The tip cover on the syringe may contain natural rubber latex. The risk of developing an allergic reaction very small, but your doctor or nurse needs to know about the allergy to decide if you or your child should be vaccinated with Bexsero.

There are no data on the use of Bexsero in people over 50 years of age. There are limited data on the use of Bexsero in patients with chronic medical conditions or with a weakened immune system. If you or your child has a weakened immune system (for example, due to the use of immunosuppressive medications, or HIV – infection, or hereditary defect in the body’s natural defense system), it is possible that the effect of Bexsero is reduced.

As with all vaccines, it is not certain that Bexsero provides complete protection for everyone who is vaccinated.

Other medicines and Bexsero

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

Bexsero can be given at the same time as other vaccines such as vaccines against diphtheria, tetanus, pertussis, Haemophilus influenzae type b, polio, hepatitis B, pneumococci, measles, mumps, rubella, chickenpox, and meningococcal infection serogroup A, C, W, Y. Talk to doctor or nurse for more information.

When co-administered with other vaccines, Bexsero must be given at a separate injection site.

Your doctor or nurse may ask you to give your child medicines that lower fever when Bexsero has been given. This helps reduce some of the side effects of Bexsero.

Pregnancy and breastfeeding

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 taking Bexsero. Your doctor may still recommend that you receive Bexsero if you are at risk of being exposed to meningococcal infection.

Driving and using machines

Bexsero has no or negligible effect 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 chloride

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘ sodium-free’. is largely “sodium-free”.

3. How to use BEXSERO

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

It is important to follow your doctor’s or nurse’s instructions so that you or your child can complete the entire injection series.

Infants aged 2 to 5 months at the time of the first dose one

Your child should receive the first batch of two or three injections of the vaccine, followed by a further injection (booster dose).

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

Infants aged 6 to 11 months at the time of the first dose one

Infants aged 6 to 11 months should receive two injections of the vaccine, followed by a further injection (booster dose).

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

Children aged 12 to 23 months at the time of the first dose one

Children aged 12 to 23 months should receive two injections of the vaccine, followed by another injection (booster dose).

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

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

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

  • The interval between each injection should be at least 1 month.

Your child may receive another injection (booster).

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

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 can get another injection (booster).

People over 50 years

There are no data for people over 50 years. Talk to your doctor if it may be helpful for you to get Bexsero.

If you have any further questions on the use of 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 most common side effects (may affect more than 1 in 10 people) that you or your child may experience (reported in all age groups):

  • pain/tenderness at the injection site, reddening of the skin at the injection site, swelling of the skin at the injection site, hardening of the skin at the injection site.

The following side effects may also occur after you or your child have been vaccinated.

Infants and children (up to 10 years)

Very common (may affect more than 1 in 10 people)

  • fever (≥38 ° C)
  • decreased appetite
  • injection site tenderness (including severe injection site tenderness which causes the baby to scream when touching the injected body part)
  • joint pain
  • skin rash (children, 12 to 23 months of age) (rare after booster dose)
  • somnolence
  • feeling of irritation
  • unusually screaming
  • vomiting (less common after booster dose)
  • diarrhea
  • headache.


Common
 (may affect up to 1 in 10 people)

  • skin rash (infants and children, 2 to 10 years of age).


Uncommon (may affect up to 1 in 100 people)

  • high fever (≥40 ° C)
  • seizures (including febrile seizures)
  • dry skin
  • pallor (rare after booster dose).


Rare (may affect up to 1 in 1,000 people)

  • Kawasaki disease may include symptoms such as fever lasting more than five days associated with a skin rash on the torso, sometimes followed by flaking of the skin on the hands and fingers, swollen glands on the neck, red eyes, lips, throat, and tongue
  • itchy rash, skin rash.


Adolescents (from 11 years) and adults

Very common (may affect more than 1 in 10 people)

  • injection site pain leading to an inability to perform normal daily activities
  • pain in muscles and joints
  • nausea
  • general malaise
  • headache.


The following side effects have been reported during post-marketing use:

Allergic reactions may include severely swollen lips, mouth, throat (which may make it difficult to swallow), difficulty breathing with wheezing or coughing, rash, unconsciousness, and very low blood pressure.

Collapse (sudden muscle weakness), less susceptible than normal or impaired consciousness, and pallor or bluish discoloration of the skin in young children.

Fainting or fainting.

Skin rash (adolescents from 11 years and adults).

Fever (adolescents from 11 years and adults).

Injection site reactions such as extensive swelling of the vaccinated body part, blisters on or around the injection site, and hard lump at the injection site (which may last for more than one month). 
Neck stiffness or unpleasant photosensitivity ( photophobia ) indicating irritation of the meninges has been reported sporadically shortly after vaccination; the symptoms have been of a mild and transient nature.

Reporting of side effects

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 to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information. 

5. How to store BEXSERO

Keep this vaccine out of the reach and sight of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.

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

Store in the original package. Sensitive to 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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

One dose (0.5 ml) contains:

Active substances:

Recombinant Neisseria meningitidis group B NHBA fusion protein 1,2,3 50 micrograms
Recombinant Neisseria meningitides 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 meningitides group B strain NZ98 / 254 measured in the amount of total protein-containing PorA P1.4 2 25 micrograms

1 produced in E. coli with recombinant DNA technology

adsorbed on aluminum hydroxide (0.5 mg Al³ + )

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

Other ingredients:

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

What the medicine looks like and the contents of the pack

Bexsero is an injection, suspension, in a prefilled syringe (type I glass) with a plunger stopper (bromobutyl rubber, type I) with a tip protector (rubber, type I or type II), with or without needles.

Pack size 1 or 10 syringes.

Suspension one is a white opalescent liquid.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

GSK Vaccines Srl

Via Fiorentina 1

53100 Siena

Italy

Manufacturer:

GSK Vaccines Srl

Bellaria ‑ Rosia

53018 Sovicille (Siena)

Italy

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienGlaxoSmithKline Pharmaceuticals sa / nvTel: + 32 10 85 52 00 LithuaniaGlaxoSmithKline Lithuania UABTel: +370 5 264 90 00info.lt@gsk.com
BulgariaThe GlaxoSmithKlein ЕООДTel. + 359 2 953 10 34 Luxembourg / LuxemburgGlaxoSmithKline Pharmaceuticals sa / nvTel: + 32 10 85 52 00
Czech RepublicGlaxoSmithKline sroTel: + 420 2 22 00 11 11cz.info@gsk.com HungaryGlaxoSmithKline Kft.Tel .: + 36‑1‑2255300
DenmarkGlaxoSmithKline Pharma A / STel: + 45 36 35 91 00dk‑info@gsk.com MaltaGlaxoSmithKline (Malta) LtdTel: + 356 21 238131
GermanyGlaxoSmithKline GmbH & Co. KGTel: +49 (0) 89 36044 8701de.impfservice@gsk.com The NetherlandsGlaxoSmithKline BVTel: + 31 (0) 33 2081100
EestiGlaxoSmithKline Eesti OÜTel: +372 667 6900estonia@gsk.com NorwayGlaxoSmithKline ASTel: + 47 22 70 20 00
GreeceGlaxoSmithKline Aονοπρόσωπη AEBETηλ: + 30 210 68 82 100 AustriaGlaxoSmithKline Pharma GmbH.Tel: + 43 (0) 1 970750at.info@gsk.com
SpainGlaxoSmithKline, SATel: + 34 900 202 700es‑ci@gsk.com PolandGSK Services Sp. z ooTel .: + 48 (22) 576 9000
FranceGlaxoSmithKline LaboratoryTel: + 33 (0) 1 39 17 84 44diam@gsk.com PortugalGlaxoSmithKline – Pharmaceutical Products, Lda.Tel: + 351 21 412 95 00FI.PT@gsk.com
CroatiaGlaxoSmithKline dooTel .: + 385 (0) 1 6051999 RomaniaGlaxoSmithKline (GSK) SRLTel: +40 (0) 21 3028 208
IrelandGlaxoSmithKline (Ireland) LtdTel: + 353 (0) 1 495 5000 SloveniaGlaxoSmithKline dooTel .: + 386 (0) 1 280 25 00medical.x.si@gsk.com
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicGlaxoSmithKline Slovakia sroTel: + 421 (0) 2 48 26 11 11recepcia.sk@gsk.com
ItalyGlaxoSmithKline SpATel: +39 (0) 45 9218 111 Finland / FinlandGlaxoSmithKline OyPuh / Tel: + 358 10 30 30 30
ΚύπροςGlaxoSmithKline (Cyprus) Ltd:Ηλ: + 357 22 39 70 00gskcyprus@gsk.com
LatviaGlaxoSmithKline Latvia SIATel: + 371 67312687lv‑epasts@gsk.com United KingdomGlaxoSmithKline UKTel: + 44 (0) 800 221 441customercontactuk@gsk.com

Muhammad Nadeem

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