Trumenba – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Trumenba, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you or your child receives this vaccine because it contains important information for you or your child
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This vaccine has been prescribed for you or your child only.
- If you get any side effects, talk to your doctor, pharmacist or nurse . This includes any possible side effects not listed in this leaflet. See sec tion 4.
ℹ️ 1. What Trumenba is and what it is used for
Trumenba is a vaccine to prevent invasive meningococcal disease, caused by Neisseria meningitidis serogroup B, for use in people 10 years and older. This is a type of bacteria that can cause s erious and sometimes life threatening infections such as meningitis (inflammation of the covering of the brain and spinal cord) and sepsis (blood poisoning).
The vaccine contains 2important components from the surface of the bacteria.
The vaccine works by helping the body to make antibodies (the body’s natural defences) which protect you or your child against this disease.
⚠️ 2. What you need to know before you or your child receives Trumenba
Trumenba should not be given
- if you or your child are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6) .
Warnings and precautions
Talk to your doctor, pharmacist or nurse before vaccination with Trumenba. Tell your doctor, pharmacist or nurse if you or your child: have a severe infection with a high fever . If this is the case, then vaccination will be postponed. The presence of a minor infection, such as a cold, should not require postponement ofthevaccination, but talk to your doctor first. have a bleeding problem or bruise easily . have a weakened immune system which may prevent you or your child from getting the full benefit from Trumenba. have had any problems after any dose of Trumenba such as an allergic reaction or problems with breathing.
Fainting, feeling faint, or other stress -related reactions can occur as a response to any needle injection.
Tell your doctor, pharmacist or nurse if you have experienced this kind of reaction previ ously.
27Other medicines and Trumenba Tell your doctor, pharmacist or nurse if you or your child are using, have recently used or might use any other medicines or have recently received any other vaccine.
Trumenba can be given at the same time as any of the following vaccine components: tetanus , diphtheria ,whooping cough (p ertussis ),poliovirus ,papillomavirus , and m eningococcal serogroups A, C, W, Y.
Administration of Trumenba with vaccines other than those mentioned above, has not been studied.
If you receive more than 1 vaccination at the same time it is important that different injection sites are used.
If you take medicines that affect your immune system (such as radiation therapy , corticosteroids , or some types of cancer chemotherapies ), you ma y not get the full benefit of Trumenba.
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 Trumenba is given. Your doctor may still recommend that you receive Trumenba if you are at risk of meningococcal disease.
Driving and using machines
Trumenba has no or little influence on the ability to drive and use machines.
However, some of the side effects mentioned under section 4 ‘Possible side effects’ may temporarily affect you. If this occurs, wait until the effects wear off before driving or using machines.
Trumenba contains polysorbate 80
This vaccine contains 0.018 mg of polysorbate 80 per dose. Polysorbates may cause allergic reactions.
Tell your doctor if you or your child has any known allergies.
Trumenba contains sodium
This vaccine contains less than 1 mmol sodium (23mg)per dose, that is to say essentially ‘sodium -free’.
💊 3. How Trumenba is given
Trumenba will be given to you or your child by a doctor , pharmacist or nurse. It will be injected into the upper arm muscle.
It is important to follow the instructions from the doctor , pharmacist or nurse so that you or your child completes the course of injections.
Individuals 10 years and older -You or your child will receive 2 injections of the vaccine, the second injection is given 6 months after the first injection ; or -You or your child will receive 2 injections of the vaccine given at least 1 month apart and a third injection at least 4 months after the second injection. -You or your child may be given a booster.
❗ 4. Possible side effects
Like all vaccines, this vaccin ecan cause side effects, although not everybody gets them.
28When Trumenba is given to your or your child, the following side effects may occur:
Very common (may affect more than 1 in 10 people)
-Redness, swelling and pain at injection site -Headache -Diarrhoea -Nausea -Muscle pain -Joint pain -Chills -Fatigue
Common (may affect up to 1 in 10 people )
-Vomiting -Fever ≥38°C
Not known (frequency cannot be estimated from the available data)
-Allergic reactions
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.
🌡️ 5. How to store Trumenba
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C-8°C).
Syringes should be stored in the refrigerator horizontally to minimize the re -dispersion time.
Do not freeze.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
📦 6. Contents of the pack and other information
What Trumenba contains
One dose (0.5 ml) contains:
Active substances:
Neisseria meningitidis serogroup B fHbp subfamily A1,2,360micrograms Neisseria meningitidis serogroup B fHbp subfamily B1,2,360micrograms 1Recombinant lipidated fHbp (factor H binding protein) 292Produced in Escherichia coli cells by recombinant DNA technology 3Adsorbed on aluminium phosphate (0.25 milligram aluminium per dose) Other ingredients :
Sodium chloride (see section 2 Trumenba contains sodium ), histidine, water for injections, and polysorbate 80 (E433 , see section 2 Trumenba contains polysorbate 80 ).
What Trumenba looks like and contents of the pack
Trumenba is a white suspension for injection, provided in a pre -filled syringe.
Pack sizes of 1, 5, and 10 pre -filled syringes with or without needles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles BelgiumManufacturer responsible for batch release:
Pfizer Manufacturing Belgium NV Rijksweg 12 2870 Puurs -Sint-Amands Belgium For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Luxembourg/Luxemburg Pfizer S.A./N.V.
Tél/Tel: + 32 (0)2 554 62 11Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel: +370 52 51 4000 България Пфайзер Люксембург САРЛ, Клон България Teл.: +359 2 970 4333Magyarország Pfizer Kft Tel: +36 1 488 3700 Česká republika Pfizer ,spol. sr.o.
Tel: + 420 283 004 111Malta Vivian Corporation Ltd.
Tel: + 35621 344610 Danmark Pfizer ApS Tlf.: + 45 44 201 100Nederland Pfizer BV Tel: +31 (0) 800 63 34 636 Deutschland Pfizer Pharma GmbH Tel: + 49 (0)30 550055 -51000Norge Pfizer AS Tlf: +47 67 52 6100 Eesti Pfizer Luxembourg SARL Eesti fili aal Tel.: +372 6 66 7500Österreich Pfizer Corporation Austria Ges.m.b.H Tel: + 43 (0)1 521 15 -0 30Ελλάδα Pfizer Ελλάς A.E.
Τηλ.: +30 210 6785 800Polska Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00 España Pfizer, S.L.
Tel+34914909900Portugal Laboratórios Pfizer, Lda.
Tel: (+351) 21 423 55 00 France Pfizer Tél +33 1 58 07 34 40România Pfizer Romania S.R.L Tel: +40 (0) 21 207 28 00 Hrvatska Pfizer Croatia d.o.o.
Tel: + 385 1 3908 777Slovenija Pfizer Luxembourg SARL Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana Tel.: + 386 (0)1 52 11 400 Ireland Pfizer Healthcare Ireland Unlimited Company Tel: 1800 633 363 (toll free) +44 (0)1304 616161Slovenská republika Pfizer Luxembourg SARL, organiza čná zložka Tel: + 421 2 3355 5500 Ísland Icepharma hf Simi: + 354 540 8000Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 040 Italia Pfizer s.r.1 Tel: +39 06 33 18 21Sverige Pfizer AB Tel: +46 (0)8 550 520 00 Κύπρος Pfizer Ελλάς Α.Ε. (Cyprus Branch) Tηλ: +357 22 817690 Latvija Pfizer Luxembourg SARL filiāle Latvijā Tel.: + 371 670 35 775
This leaflet was last revised in
Other sources of information Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu .
This leaflet is available in all EU/EEA languages on the European Medicines Agency website. —————————————————————————————————————————
🩺 Information intended for healthcare professionals only
31During storage, a white deposit and clear supernatant may be observed.
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.
Shake well prior to use to obtain a homogeneous white suspension.
Trumenba is for intramuscular use only. Do not administer intravascularly or subcutaneously.
Trumenba must not be mixed with any other vaccines in the same syringe.
When given at the same time with other vaccines Trumenba must be given at separate injection sites.
Any unused vaccine or waste material should be disposed of in accordance with local requirements.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Trumenba (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/17/1187).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.