Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - bexsero

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Generated Narrative: MedicinalProductDefinition mp69c2bef02c7fe63e8cfc997db1e3d8f8

identifier: http://ema.europa.eu/identifier/EU/1/12/812/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Bexsero suspension for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-69c2bef02c7fe63e8cfc997db1e3d8f8

identifier: http://ema.europa.eu/identifier/EU/1/12/812/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - bexsero

Attesters

What is in 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

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.

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 and precautions

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.

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.

Other medicines and Bexsero

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.

Pregnancy and breast-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 Bexsero is given. Your doctor may still recommend that you receive Bexsero if you are at risk of exposure to meningococcal infection.

Driving and using machines

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.

Bexsero contains sodium chloride

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.

Infants 2 months to 5 months of age at the time of first dose

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 at the time of first dose

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 at the time of first dose

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 at the time of first dose

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 and adults from 11 years of age at the time of 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 an additional injection (booster).

Adults above 50 years of age

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.

Infants and children (up to 10 years of age)

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

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

Uncommon (these may affect up to 1 in 100 people): high fever ( 40 C), seizures (including febrile seizures), dry skin, paleness (rare after booster).

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

Adolescents (from 11 years of age) and adults

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

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 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 and the pre-filled syringe label 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.

What Bexsero contains

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

1 produced in E. coli cells by recombinant DNA technology 2 adsorbed on aluminium hydroxide (0.5 mg Al3+) 3 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).

What Bexsero looks like and contents of the pack

Bexsero is a white opalescent suspension. Bexsero is available in 1-dose pre-filled syringe with or without separate needles, pack sizes of 1 and 10. 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien GlaxoSmithKline Pharmaceuticals SA/NV T l/Tel: + 32 10 85 52 Lietuva GSK Vaccines S.r.l. Tel: +370 80000
GSK Vaccines S.r.l. . +359 80018Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals SA/NV T l/Tel: + 32 10 85 52 esk republika GlaxoSmithKline s.r.o. Tel: + 420 2 22 00 11 cz.info@gsk.com

Magyarorsz g GSK Vaccines S.r.l. Tel.: +36 80088Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 dk-info@gsk.com

Malta GSK Vaccines S.r.l. Tel: +356 80065Deutschland GlaxoSmithKline GmbH & Co. KG Tel: +49 (0)89 36044 8de.impfservice@gsk.com
Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081Eesti GSK Vaccines S.r.l. Tel: +372 8002Norge GlaxoSmithKline AS Tlf: + 47 22 70 20
GlaxoSmithKline A.E.B.E T : + 30 210 68 82 sterreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 at.info@gsk.com

Espa a GlaxoSmithKline, S.A. Tel: + 34 900 202 es-ci@gsk.com

Polska GSK Services Sp. z o.o. Tel.: + 48 (22) 576 9France Laboratoire GlaxoSmithKline T l: + 33 (0) 1 39 17 84 diam@gsk.com
Portugal GlaxoSmithKline - Produtos Farmac uticos, Lda. Tel: + 351 21 412 95 FI.PT@gsk.com

Hrvatska GSK Vaccines S.r.l. Tel.: +385 800787Rom nia GSK Vaccines S.r.l. Tel: +40 800672Ireland GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 495 5Slovenija GSK Vaccines S.r.l. Tel: +386 80688 sland Vistor hf.
S mi: +354 535 7Slovensk republika GSK Vaccines S.r.l. Tel.: +421 800500Italia GlaxoSmithKline S.p.A. Tel: +39 (0)45 7741 Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 10 30 30
GSK Vaccines S.r.l. : +357 80070Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 info.produkt@gsk.com

Latvija GSK Vaccines S.r.l. Tel: +371 80205United Kingdom (Northern Ireland) GSK Vaccines S.r.l. Tel: +44(0)800 221customercontactuk@gsk.com

This leaflet was last revised in {MM/YYYY}

Detailed information on this medicine is available on the European Medicines Agency web site: