Trumenba

Package leaflet: Information for the user

Trumenba injectable suspension in a pre-filled syringe

meningococcal group B vaccine
(recombinant, adsorbed)
Please read all of this leaflet carefully before you or your child receives this medicine because it contains important information for you or your child.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This vaccine has been prescribed only for you or your child.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Trumenba is and what it is used for
2. What you need to know before you or your child receives Trumenba
3. How to use Trumenba
4. Possible side effects
5. How to store Trumenba
6. Contents of the pack and other information

1. What Trumenba is and what it is used for

Trumenba is a vaccine for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B, used in individuals 10 years of age and older. This type of bacterium can cause serious infections, such as meningitis (inflammation of the membranes covering the brain and spinal cord) and sepsis (blood infection), which may sometimes be life-threatening.
The vaccine contains 2 important components from the surface of the bacteria.
The vaccine works by helping the body produce antibodies (the body's natural defenses) that protect you or your child against this disease.

2. What you should know before you or the child receive Trumenba

Do not use Trumenba

• if you or the child are allergic to the active substance or to 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. Inform the
doctor, pharmacist, or nurse if you or the child:

• have a severe infection with high fever. In this case, vaccination will be postponed. A mild infection, such as a cold, should not delay vaccination, but inform the doctor first.
• have a bleeding disorder or bruise easily.
• have a weakened immune system, which may prevent you or the child from getting the full benefit from Trumenba.
• experience problems after any dose of Trumenba, such as an allergic reaction or breathing difficulties.

Fainting, feeling faint, or other stress-related reactions may occur following any injection with a needle. Talk to your doctor, pharmacist, or nurse if you have previously experienced such reactions.

Other medicines and Trumenba
Inform your doctor, pharmacist, or nurse if you or the child are taking, have recently taken, or might take any other medicines, or if you have recently received any other vaccinations.
Trumenba may be administered simultaneously with any of the components of the following vaccines: tetanus, diphtheria, pertussis, poliovirus, papillomavirus, and meningococcal serogroups A, C, W, Y.
Administration of Trumenba together with vaccines other than those listed above has not been studied.
If more than one vaccine is administered at the same time, it is important to use different injection sites.
If you are taking medicines that affect the immune system (such as radiotherapy, corticosteroids, or certain types of anticancer chemotherapy), you may not get the full benefit from Trumenba.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor for advice before receiving Trumenba vaccination. If you are at risk of meningococcal disease, your doctor may still recommend that you receive Trumenba vaccination.

Driving and using machines
Trumenba does not alter or alters negligibly the ability to drive vehicles or use machinery.
However, some of the adverse reactions mentioned in section 4 “Possible side effects” may temporarily affect you. In such cases, wait until the effects have subsided before driving or using machinery.

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 known allergies.

Trumenba contains sodium
This vaccine contains less than 1 mmol (23 mg) of sodium per dose, i.e. it is essentially “sodium-free”.

3. How to use Trumenba

Trumenba will be administered to you or to the child by a doctor, pharmacist, or nurse. It will be injected into the muscle of the upper arm.
It is important to follow the instructions of the doctor, pharmacist, or nurse to complete the injection schedule for you or for the child.
Individuals aged 10 years and older

• You, or the child, will receive 2 injections of the vaccine, with the second injection given 6 months after the first injection; or
• You, or the child, will receive 2 injections of the vaccine administered at least 1 month apart, and a third injection at least 4 months after the second injection.
• You, or the child, may receive a booster dose.

4. Possible side effects

Like all vaccines, this vaccine may cause side effects, although not everybody gets them.
When Trumenba is administered to you or to the 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 of 38 °C

Not known (frequency cannot be estimated from the available data)

• Allergic reactions

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system listed in Annex 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 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 horizontally in the refrigerator to minimize re-dispersion time.
Do not freeze.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Trumenba contains
One dose (0.5 ml) contains:
Active substances:
fHbp from Neisseria meningitidis serogroup B subfamily A 60 micrograms
fHbp from Neisseria meningitidis serogroup B subfamily B 60 micrograms
recombinant lipidated fHbp (factor H binding protein)
Produced in Escherichia coli cells using recombinant DNA technology
Adsorbed on aluminium phosphate (0.25 milligrams of aluminium per dose)
Other components:
Sodium chloride (see section 2 Trumenba contains sodium), histidine, water for
injection, and polysorbate 80 (E433, see section 2 Trumenba contains polysorbate 80).

Description of the appearance of Trumenba and contents of the pack
Trumenba is a white injectable suspension supplied in a pre-filled syringe.
Pack sizes: 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 Brussels
Belgium

Responsible manufacturer for batch release:
Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien
Pfizer S.A./N.V.
Tél/Tel: +32 (0)2 554 62 11

България
Пфайзер Люксембург САРЛ, Клон България
Teл.: +359 2 970 4333

Česká republika
Pfizer, spol. s r.o.
Tel: +420 283 004 111

Danmark
Pfizer ApS
Tlf.: +45 44 201 100

Deutschland
Pfizer Pharma GmbH
Tel.: +49 (0)30 550055-51000

Eesti
Pfizer Luxembourg SARL Eesti filial
Tel: +372 666 7500

Ελλάδα
Pfizer Ελλάς A.E.
Τηλ.: +30 210 6785 800

España
Pfizer, S.L.
Tel: +34 914909900

France
Pfizer
Tél: +33 1 58 07 34 40

Hrvatska
Pfizer Croatia d.o.o.
Tel: +385 1 3908 777

Ísland
Icepharma hf
Simi: +354 540 8000

Ireland
Pfizer Healthcare Ireland Unlimited Company
Tel: 1800 633 363 (toll free)
Tel: +44 (0)1304 616161

Italia
Pfizer s.r.l.
Tel: +39 06 33 18 21

Κύπρος
Pfizer Ελλάς Α.Ε. (Cyprus Branch)
Tηλ: +357 22 817690

Latvija
Pfizer Luxembourg SARL filiāle Latvijā
Tel: +371 670 35 775

Lietuva
Pfizer Luxembourg SARL filialas Lietuvoje
Tel: +370 52 51 4000

Luxembourg/Luxemburg
Pfizer Luxembourg SARL
Tel: +32 (0)2 554 62 11

Magyarország
Pfizer Kft
Tel.: +36 1 488 3700

Malta
Vivian Corporation Ltd.
Tel: +356 21 344610

Nederland
Pfizer BV
Tel: +31 (0)800 63 34 636

Norge
Pfizer AS
Tlf: +47 67 526 100

Österreich
Pfizer Corporation Austria Ges.m.b.H
Tel: +43 (0)1 521 15-0

Polska
Pfizer Polska Sp. z o.o.
Tel.: +48 22 335 61 00

Portugal
Laboratórios Pfizer, Lda.
Tel: (+351) 21 423 55 00

România
Pfizer Romania S.R.L
Tel: +40 (0) 21 207 28 00

Slovenija
Pfizer Luxembourg SARL, Pfizer, podružnica za svetovanje s področja farmacevtske dejavnosti, Ljubljana
Tel.: +386 (0) 1 52 11 400

Slovenská republika
Pfizer Luxembourg SARL, organizačná zložka
Tel: +421 2 3355 5500

Suomi/Finland
Pfizer Oy
Puh/Tel: +358 (0)9 430 040

Sverige
Pfizer AB
Tel: +46 (0)8 550 520 00

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu/.
This leaflet is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.
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The following information is intended for healthcare professionals only:
During storage, formation of a white deposit and a clear supernatant may be observed.
Before administration, the vaccine should be visually inspected for the presence of foreign particulate matter and any change in colour. Do not administer the vaccine if foreign particulate matter and/or physical appearance changes are observed.
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.
If administered simultaneously with other vaccines, Trumenba must be given at a separate injection site.
Any unused vaccine and waste material derived from this medicinal product must be disposed of in accordance with local regulations.