Trumenba suspension inyectable en jeringa precargada

Patient Information Leaflet

Trumenba Pre-filled Suspension for Injection

Meningococcal Group B Vaccine

(Recombinant, Adsorbed)

Please read this leaflet carefully before you or your child receives this vaccine, as it contains important information for you or your child.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This vaccine has been prescribed for you or your child only.
• If you experience any side effects, consult your doctor, pharmacist or nurse,even if they are not listed in this leaflet. See section4.

Trumenba is a vaccine to prevent invasive meningococcal disease, caused byNeisseria meningitidisserogroup B, for use in individuals 10 years of age and older. This type of bacteria can cause severe and sometimes fatal infections, such as meningitis (inflammation of the brain and spinal cord covering) and sepsis (blood infection).

The vaccine contains 2 important components of the bacterial surface.

The vaccine works by helping the body to produce antibodies (natural defenses of the body) that protect you or your child from this disease.

Do not administer Trumenba

-if you or your child is allergic to the active ingredient or to any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor, pharmacist, or nurse before vaccination with Trumenba. Inform your doctor, pharmacist, or nurse if you or your child:

• has 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 speak with your doctor first.
• has bleeding problems or easily gets bruises.
• has a weakened immune system that may prevent you or your child from obtaining a full benefit from Trumenba.
• has had any problems after a dose of Trumenba, such as an allergic reaction or difficulty breathing.

Fainting, feeling weak, or other reactions associated with stress may occur as a response to any injection with a needle. Inform your doctor, pharmacist, or nurse if you have had this type of reaction previously.

Other medications and Trumenba

Inform your doctor, pharmacist, or nurse if you or your child are using, have used recently, or may need to use any other medication or if you have recently received another vaccine.

Trumenba can be administered at the same time as any of the following vaccine components: tetanus, diphtheria, and pertussis (whooping cough), poliovirus, and human papillomavirus, and meningococcal serogroups A, C, W, and Y.

Trumenba has not been studied with vaccines other than those listed above.

If you receive more than one vaccine at the same time, it is essential to use different injection sites.

If you are taking medications that affect your immune system (such as radiation therapy, corticosteroids, or certain types of chemotherapy for cancer), you may not obtain a full benefit from Trumenba.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor before Trumenba is administered. Your doctor may recommend continued administration of Trumenba if you are at risk of exposure to meningococcal infection.

Driving and operating machinery

The influence of Trumenba on the ability to drive and operate machinery is negligible or insignificant.

However, some of the adverse effects mentioned in section 4 “Possible adverse effects” may temporarily affect you. If this occurs, wait until the effects have disappeared before driving or operating machinery.

Trumenba contains sodium

This medication contains less than1mmol of sodium(23 mg) per dose; this is essentially “sodium-free”.

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 essential 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 administered 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.

Like all vaccines, this vaccine may produce adverse effects, although not all people may experience them.

When administering Trumenba to you or your child, the following adverse effects may occur:

VeryFrequent(may affect more than 1 in 10people)

• Redness, swelling, and pain at the injection site
• Headache
• Diarrhea
• Nausea
• Muscle pain
• Joint pain
• Chills
• Fatigue

Frequent(may affect up to 1 in 10 people)

• Vomiting
• Fever ≥ 38°C

Unknown Frequency(cannot be estimated from available data)

• Allergic reactions

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it ispossible adverse effects that do not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the label and on the packaging after EXP. The expiration date is the last day of the month indicated.

Store in refrigerator (between 2°C and 8°C).

Syringes should be stored in the refrigerator horizontally to minimize re-dispersion time.

Do not freeze.

Do not dispose of medications through drains or trash. Ask your pharmacist how to dispose of empty containers and unused medications. This will help protect the environment.

Composition of Trumenba

A dose (0.5 ml) contains:

Active ingredients:

fHbp from subfamily A ofNeisseria meningitidisserogroup B 1,2,360micrograms

fHbp from subfamily B ofNeisseria meningitidisserogroup B 1,2,360micrograms

1recombinant lipidated fHbp (factor H binding protein)

2produced inEscherichia colicells using recombinant DNA technology

3adsorbed on aluminium phosphate (0.25 milligrams of aluminium per dose)

Other components:

Sodium chloride (see section 2 “Trumenba contains sodium”), histidine, water for injection, aluminium phosphate and polisorbate 80 (E433).

Appearance of Trumenba and contents of the pack

Trumenba is a white injectable suspension, in pre-filled syringe.

Available pack sizes: 1, 5 and 10 pre-filled syringes, with or without needles.

Only some pack sizes may be marketed.

Marketing authorisation holder and responsible person for manufacturing

For further information about this medicinal product, please consult the representative of the marketing authorisation holder in your country:

Last update of this leaflet:09/2024.

Other sources of information

Further information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/.

This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.

<---------------------------------------------------------------------------------------------------------------->

This information is intended for healthcare professionals only:

During storage, a white deposit and a transparent supernatant may be observed.

Inspect the vaccine visually for any particulate matter and discoloration before administration. If any particulate matter or variation in physical appearance is observed, do not administer the vaccine.

Shake well before use to obtain a white homogeneous suspension.

Trumenba is for intramuscular use only. Do not administer by intravascular or subcutaneous route.

Trumenba must not be mixed with other vaccines in the same syringe.

When administered with other vaccines, Trumenba should be administered in a separate injection site.

The disposal of unused medicinal product and any waste materials derived from the use of this product should be in accordance with local requirements.