Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - trumenba

Document Subject

Generated Narrative: MedicinalProductDefinition mpdda2c427548650874074bbc49aa90b54

identifier: http://ema.europa.eu/identifier/EU/1/17/1187/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Trumenba suspension for injection in pre-filled syringe

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-dda2c427548650874074bbc49aa90b54

identifier: http://ema.europa.eu/identifier/EU/1/17/1187/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - trumenba

Attesters

What is in 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 Trumenba is given
4. Possible side effects
5. How to store Trumenba
6. Contents of the pack and other information

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 serious 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 2 important 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.

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 of the vaccination, 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 previously.

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 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 (pertussis), poliovirus, papillomavirus, and meningococcal 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 may 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 sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially sodium-free .

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.

Like all vaccines, this vaccine can cause side effects, although not everybody gets them.

When 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.

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.

What Trumenba contains

One dose (0.5 ml) contains:

Active substances:

Neisseria meningitidis serogroup B fHbp subfamily A1,2,3
60 micrograms Neisseria meningitidis serogroup B fHbp subfamily B1,2,3
60 micrograms

1 Recombinant lipidated fHbp (factor H binding protein) 2 Produced in Escherichia coli cells by recombinant DNA technology 3 Adsorbed 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).

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 1050 Bruxelles Belgium

Manufacturer responsible for batch release: Pfizer Manufacturing Belgium NV Rijksweg 2870 Puurs-Sint-Amands
Belgium

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgi /Belgique/Belgien Luxembourg/Luxemburg Pfizer S.A./N.V. T l/Tel: + 32 (0)2 554 62 Lietuva Pfizer Luxembourg SARL filialas Lietuvoje Tel: +370 52 51 4
,

Te .: +359 2 970 4Magyarorsz g Pfizer Kft Tel: +36 1 488 3 esk republika Pfizer, spol. s r.o. Tel: + 420 283 004 Malta Vivian Corporation Ltd. Tel: + 35621 344Danmark Pfizer ApS Tlf: + 45 44 201 Nederland Pfizer BV Tel: +31 (0)800 63 34 Deutschland Pfizer Pharma GmbH Tel: + 49 (0)30 550055-51Norge Pfizer AS Tlf: +47 67 52 61 Eesti Pfizer Luxembourg SARL Eesti filiaal Tel.: +372 666 7 sterreich Pfizer Corporation Austria Ges.m.b.H Tel: + 43 (0)1 521 15-0

Pfizer A.E. .: +30 210 6785 Polska Pfizer Polska Sp. z o.o. Tel.: +48 22 335 61 Espa a Pfizer, S.L. Tel+34914909Portugal Laborat rios Pfizer, Lda. Tel: (+351) 21 423 55 France Pfizer T l +33 1 58 07 34 Rom nia Pfizer Romania S.R.L Tel: +40 (0) 21 207 28 Hrvatska Pfizer Croatia d.o.o. Tel: + 385 1 3908 Slovenija Pfizer Luxembourg SARL Pfizer, podru nica za svetovanje s podro ja farmacevtske dejavnosti,
Ljubljana Tel.: + 386 (0)1 52 11 Ireland Pfizer Healthcare Ireland Tel: 1800 633 363 (toll free) +44 (0)1304 616Slovensk republika Pfizer Luxembourg SARL, organiza n zlo ka Tel: + 421 2 3355 5 sland Icepharma hf Simi: + 354 540 8Suomi/Finland Pfizer Oy Puh/Tel: +358 (0)9 430 Italia Pfizer s.r.1 Tel: +39 06 33 18 Sverige Pfizer AB Tel: +46 (0)8 550 520
Pfizer . . (Cyprus Branch) T : +357 22 817United Kingdom (Northern Ireland) Pfizer Limited Tel: +44 (0) 1304 616Latvija Pfizer Luxembourg SARL fili le Latvij
Tel.: + 371 670 35 This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

The following information is intended for healthcare professionals only:

During 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.