solution for injection, suspension in pre-filled syringe
meningococcal group B vaccine ( recombinant, adsorbed )
What Trumenba is and what it is used for
Trumenba is a vaccine given to people from the age of 10 and is intended to prevent invasive meningococcal disease, caused by Neisseria meningitides serogroup B. This type of bacteria 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 contains 2 important components from the surface of the bacterium.
The vaccine works by helping the body form antibodies (the body’s natural defense system) that protect you or your child against this disease.
What you need to know before you or your child is given Trumenba
Trumenba should not be given
- if you or your child is allergic to the active substance or any other ingredient in this medicine (listed in section 6).
Warnings and precautions
Talk to a doctor, pharmacist o,r nurse before vaccination with Trumenba. Tell the doctor, pharmacist o,r nurse 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 lead to postponing the vaccination but talk to the doctor first.
- have a bleeding disorder or bruise easily.
- have a weakened immune system which may impair the effect of Trumenba for you or your child.
- have had any problems after a dose of Trumenba, such as an allergic reaction or difficulty breathing.
Fainting, feeling faint, or other stress-related reactions may occur as a reaction to a needle stick. Tell your doctor, pharmacist, or nurse if you have experienced this type of reaction before.
Other medicines and Trumenba
Tell the doctor, pharmacist o,r nurse if you or your child are taking, or have recently taken o,r might take any other medicines, or have recently received any other vaccine.
Trumenba can be given simultaneously with the following vaccine components: tetanus, diphtheria, whooping cough (pertussis), poliovirus, papillomavirus a, and meningococcal serogroups A, C, W, Y.
the administration of Trumenba with vaccines other than those mentioned above has not been studied.
If you receive more than one vaccination at the same time, different injection sites must be used.
If you take medicines that affect your immune system (for example radiation treatment, corticosteroids o,r any type of chemotherapy against cancer) the effect of Trumenba may be reduced.
Pregnancy, breastfeeding a, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor before giving Trumenba. The doctor may still recommend that you receive Trumenba if you are at risk of meningococcal disease.
Driving ability and use of machinery
Trumenba has no or negligible effect on the ability to drive and use machines.
However, some of the effects mentioned in section 4 “Potential side effects” may temporarily affect you. If this happens, wait until the effect wears off before driving or using machinery.
Trumenba contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose,i.e. it is almost “sodium-free”.
How Trumenba is given
Trumenba is given to you or your child by a doctor, pharmacist o,r nurse. It is injected into the muscle of the upper arm.
It is important to follow the doctor’s, pharmacist’s o,r nurse’s instructions so that you or your child complete the entire series of injections.
Persons 10 years and older
- You or your child will receive two injections of the vaccine. The second injection is given six months after the first injection .or
- You or your child will receive two injections given at least one month apart and a third injection given at least four months after the second injection . You or your child may receive a refill dose.
Possible side effects
Like all vaccines, this vaccine can cause side effects, but not all users will get them.
When Trumenba is given to you or your child, the following side effects may occur:
Very common (may affect more than 1 in 10 users)
- Redness, swelling, and pain at the injection site
- Headache
- Diarrhea
- Nausea
- Muscle pain
- Joint pain
- Overindulge
- Fatigue
Common (may affect up to 1 in 10 users)
- Vomiting
- Fever ≥ 38 °C
Has been reported (occurring in an unknown number of users)
- Allergic reactions
How to store Trumenba
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label and one carton after “EXP”. The expiration date is the last day of the specified month.
Store in a refrigerator (2 °C‑8 °C).
The syringes should be stored lying down in a refrigerator to minimize the time for redispersion.
Do not freeze.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
| One dose (0.5 ml) contains:Active substances: | |
| Neisseria memeningitideserogroup B fHbp, subfamily A 1,2,3 | 60 micrograms |
| Neisseria memeningitideserogroup B fHbp, subfamily B 1,2,3 | 60 micrograms |
| 1 Recombinant lipid-modified fHbp (factor H-binding protein )2 Produced in Escherichia coli cells by recombinant DNA technology3 Adsorbed on aluminum phosphate (0.25 milligrams of aluminum per dose ) |
Other ingredients:
Sodium chloride (see section 2 Trumenba contains sodium ), histidine, water for injections, and polysorbate 80 (E433).
Appearance and package sizes of the medicine
Trumenba is a white suspension for injection in a pre-filled syringe.
Pack size 1, 5 o,r 10 pre-filled syringes, with or without needles.
Not all pack sizes may be marketed.
| Marketing Authorisation Holder:Pf izer Europe MA EEIGBoulevard de la Plaine 171050 BrusselsBelgium | Manufacturer responsible for batch release: Pf izer Manufacturing Belgium NVRijksweg 12B-2870 PuursBelgium |
Contact the representative of the Marketing Authorization Holder if you would like to know more about this medicine:
| België/Belgique/Belgien Luxembourg/LuxemburgPfizer SA/NVTel/Tel: + 32 (0)2 554 62 11 | LithuaniaPfizer Luxembourg SARL branches in LithuaniaPhone: +370 52 51 4000 |
| BulgariaPfizer Luxembourg САРЛ, КлонBulgariaPhone: +359 2 970 4333 | MagyarországPfizer KftPhone: +36 1 488 3700 |
| Czech RepublicPfizer, coil. s roiPhone+ 420 283 004 111 | MaltaVivian Corporation Ltd.Phone: + 35621 344610 |
| DenmarkPfizer ApSPhone: + 45 44 201 100 | The NetherlandsPfizer BVPhone: +31 (0)10 406 43 01 |
| DeutschlandPfizer Pharma GmbHPhone: + 49 (0)30 550055-51000 | NorwayPfizer ASiPhone+47 67 52 61 00 |
| EstoniaPfizer Luxembourg SARL Eesti by branches +372 666 7500 | AustriaPfizer Corporation Austria Ges.mbHPhone: + 43 (0)1 521 15-0 |
| GreecePfizer Hellas AETel.: +30 210 6785 800 | PolishPfizer Polska Sp. z o. oTel.: +48 22 335 61 00 |
| SpainPfizer, SLcellphone+34914909900 | PortugalLaboratórios Pfizer, Lda.Phone: (+351) 21 423 55 00 |
| FrancePfizerPhone +33 1 58 07 34 40 | RomaniaPfizer Romania SRLPhone: +40 (0) 21 207 28 00 |
| HrvatskaPfizer Croatia dooPhone: + 385 1 3908 777 | SlovenijaPfizer Luxembourg SARLTel.: + 386 (0)1 52 11 400 |
| IrelandPfizer Healthcare IrelandPhone: 1800 633 363 (toll free)+44 (0)1304 616161 | Slovenian RepublicPfizer Luxembourg SARL,organizačná zložkaPhone: + 421 2 3355 5500 |
| IcelandIcepharma hfSimi: + 354 540 8000 | Finland/FinlandPfizer OyPhone/Tel: +358 (0)9 430 040 |
| ItalyPfizer Italia srsulfone+39 06 33 18 21 | SwedenPfizer ABPhone: +46 (0)8 550 520 00 |
| CyprusPfizer Ελλάς Α.Ε. (Cyprus Branch)Phone: +357 22 817690 | United Kingdom (Northern Ireland)Pfizer LimitedPhone: +44 (0) 1304 616161 |
| LatviaPfizer Luxembourg SARL branch in LatviaTel.: + 371 670 35 775 |