TRUMENBA INJECTABLE SUSPENSION IN PRE-FILLED SYRINGE
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Introduction
Package Leaflet: Information for the Patient
Trumenba injectable suspension in a pre-filled syringe
vaccine against meningococcal group B
(recombinant, adsorbed)
Read all of this leaflet carefully before you or your child receive 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 experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
Contents of the package leaflet
- What is Trumenba and what is it used for
- What you need to know before you or your child receive Trumenba
- How Trumenba is administered
- Possible side effects
- Storage of Trumenba
- Contents of the pack and further information
1. What is Trumenba and what is it used for
Trumenba is a vaccine to prevent invasive meningococcal disease, caused by Neisseria meningitidisserogroup B, for use in individuals 10 years of age and older. This type of bacteria can cause serious and sometimes life-threatening infections, such as meningitis (inflammation of the lining of the brain and spinal cord) and sepsis (blood infection).
The vaccine contains 2 important components of the surface of the bacteria.
The vaccine works by helping the body to produce antibodies (the body's natural defenses) that protect you or your child against this disease.
2. What you need to know before you or your child receive Trumenba
Trumenba must not be administered
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before vaccination with Trumenba. Inform your doctor, pharmacist, or nurse if you or your child:
- Have a severe infection with high fever. In this case, vaccination will be postponed. The presence of a minor infection, such as a cold, is not a reason to postpone vaccination, but talk to your doctor first.
- Have bleeding problems or bruise easily.
- Have a weakened immune system that may prevent you or your child from getting the full benefit of Trumenba.
- Have had any problems after a dose of Trumenba, such as an allergic reaction or difficulty breathing.
Fainting, feeling weak, or other reactions related to stress, such as a response to any injection with a needle, may occur. Inform your doctor, pharmacist, or nurse if you have had this type of reaction before.
Other medicines and Trumenba
Tell your doctor, pharmacist, or nurse if you or your child are using, have recently used, or might use any other medicine, or if you have recently been given another vaccine.
Trumenba can be administered at the same time as any of the following vaccine components: tetanus, diphtheria, and pertussis, poliovirus, and human papillomavirus, and meningococcal serogroups A, C, W, and Y.
The administration of Trumenba with vaccines other than those listed above has not been studied.
If you receive more than one vaccine at the same time, it is important to use different injection sites.
If you are taking medicines that affect your immune system (such as radiation therapy, corticosteroids, or some types of chemotherapy for cancer), you may not get the full benefit of Trumenba.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before you receive Trumenba. Your doctor may still recommend that you receive Trumenba if you are at risk of exposure to meningococcal infection.
Driving and using machines
Trumenba has no or negligible influence on the ability to drive and use machines.
However, some of the side effects mentioned in section 4 "Possible side effects" may temporarily affect you. If this happens, wait until the effects have disappeared 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. Inform your doctor if you or your child have any known allergy.
Trumenba contains sodium
This vaccine contains less than 1 mmol of sodium (23 mg) per dose; i.e., it is essentially "sodium-free".
3. How Trumenba is administered
Trumenba will be administered to you or your child by a doctor, pharmacist, or nurse. It will be injected into a muscle in the upper arm.
It is important that you follow the doctor's, pharmacist's, or nurse's instructions so that you or your child complete the series of injections.
Individuals 10 years of age and older
- You or your child will receive 2 injections of the vaccine, with the second injection given 6 months after the first;
or
- You or your child will receive 2 injections of the vaccine with an interval of at least 1 month, and a third injection at least 4 months after the second.
- You or your child may receive a booster dose.
4. Possible side effects
Like all vaccines, this vaccine can cause side effects, although not everybody gets them.
When Trumenba is administered to you or your child, the following side effects may occur:
Very common(may affect more than 1 in 10 people)
- Redness, swelling, and pain at the injection site
- Headache
- Diarrhea
- Nausea
- Muscle pain
- Joint pain
- Chills
- Fatigue
Common(may affect up to 1 in 10 people)
- Vomiting
- Fever ≥ 38°C
Frequency not known(cannot be estimated from the available data)
- Allergic reactions
Reporting of side effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through 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. Storage of 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 is the last day of the month shown.
Store in a refrigerator (between 2°C and 8°C).
The syringes should be stored in the refrigerator horizontally to minimize the time of re-dispersion.
Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the pack and further information
Composition of Trumenba
One dose (0.5 ml) contains:
Active substances:
fHbp from the A subfamily of Neisseria meningitidisserogroup B 60 micrograms
fHbp from the B subfamily of Neisseria meningitidisserogroup B 60 micrograms
1 recombinant lipidated fHbp (factor H binding protein)
2 produced in Escherichia colicells using recombinant DNA technology
3 adsorbed on aluminum phosphate (0.25 milligrams of aluminum per dose)
Other components:
Sodium chloride (see section 2 "Trumenba contains sodium"), histidine, water for injections, aluminum phosphate, and polysorbate 80 (E433, see section 2 "Trumenba contains polysorbate 80").
Appearance and pack of Trumenba
Trumenba is a white injectable suspension 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 authorization holder and manufacturer
Marketing authorization holder: Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Brussels Belgium | Manufacturer responsible for batch release: Pfizer Manufacturing Belgium NV Rijksweg 12 2870 Puurs-Sint-Amands Belgium |
You can request more information about this medicine from the local representative of the marketing authorization holder:
Belgium/Belgique/Belgien Luxembourg/Luxemburg Pfizer S.A./N.V. Tel: +32 (0)2 554 62 11 | Lithuania Pfizer Luxembourg SARL, Lithuanian branch Tel: +370 52 51 4000 |
Bulgaria Pfizer Bulgaria EOOD Tel: +359 2 970 4333 | Hungary Pfizer Kft Tel: +36 1 488 3700 |
Czech Republic Pfizer, spol. s r.o. Tel: +420 283 004 111 | Malta Vivian Corporation Ltd. Tel: +356 21 344 610 |
Denmark Pfizer ApS Tel: +45 44 201 100 | Netherlands Pfizer BV Tel: +31 (0)800 63 34 636 |
Germany Pfizer Pharma GmbH Tel: +49 (0)30 550055-51000 | Norway Pfizer AS Tel: +47 67 52 61 00 |
Estonia Pfizer Luxembourg SARL, Estonian branch Tel: +372 666 7500 | Austria Pfizer Corporation Austria Ges.m.b.H. Tel: +43 (0)1 521 15-0 |
Greece Pfizer Hellas A.E. Tel: +30 210 6785 800 | Poland Pfizer Polska Sp. z o.o. Tel: +48 22 335 61 00 |
Spain Pfizer, S.L. Tel: +34 91 490 99 00 | Portugal Laboratórios Pfizer, Lda. Tel: (+351) 21 423 55 00 |
France Pfizer Tel: +33 1 58 07 34 40 | Romania Pfizer Romania S.R.L. Tel: +40 (0)21 207 28 00 |
Croatia Pfizer Croatia d.o.o. Tel: +385 1 3908 777 | Slovenia Pfizer Luxembourg SARL, Slovenian branch Tel: +386 (0)1 52 11 400 |
Ireland Pfizer Healthcare Ireland Unlimited Company Tel: 1800 633 363 (toll free) +44 (0)1304 616161 | Slovakia Pfizer Luxembourg SARL, Slovak branch Tel: +421 2 3355 5500 |
Iceland Icepharma hf Tel: +354 540 8000 | Finland Pfizer Oy Tel: +358 (0)9 430 040 |
Italy Pfizer s.r.l. Tel: +39 06 33 18 21 | Sweden Pfizer AB Tel: +46 (0)8 550 520 00 |
Cyprus Pfizer Hellas A.E. (Cyprus branch) Tel: +357 22 817 690 | |
Latvia Pfizer Luxembourg SARL, Latvian branch Tel: +371 670 35 775 |
Date of last revision of this leaflet: 04/2025.
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.
The leaflet can be found on the European Medicines Agency website in all languages of the European Union/European Economic Area.
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This information is intended for healthcare professionals only:
During storage, a white deposit and a clear supernatant may be observed.
Inspect the vaccine visually for particulate matter and discoloration prior to administration. If any foreign particles and/or change in physical appearance are observed, do not administer the vaccine.
Shake well before 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 other vaccines in the same syringe.
When administered at the same time as other vaccines, Trumenba should be administered in a separate injection site.
Disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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