MENVEO SOLUTION FOR INJECTION

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Menveo injectable solution

Meningococcal (groups A, C, W-135 and Y) conjugate vaccine

Read all of this leaflet carefully before you or your child are given this medicine because it contains important information for you.

• 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 adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Menveo is and what it is used for

Menveo is a vaccine used for the active immunization of children (from 2 years of age), adolescents, and adults who are at risk of exposure to a bacterium called Neisseria meningitidis of serogroups A, C, W-135, and Y, in order to prevent invasive diseases. The vaccine works by stimulating your body to produce its own protection (antibodies) against these bacteria.

Bacteria from the A, C, W-135, and Y serogroups of Neisseria meningitidis can cause serious infections that may even be life-threatening, such as meningitis or septicemia (blood poisoning).

Menveo cannot cause bacterial meningitis. This vaccine contains a protein (called CRM197) from the bacterium that causes diphtheria. Menveo does not protect against diphtheria. Therefore, you (or your child) should receive other vaccines that protect against diphtheria when the time comes or as advised by your doctor.

2. What you need to know before you or your child are given Menveo

Do not administer Menveo to yourself or your child if

• you have ever had an allergic reaction to the active substances or to any of the other components of this vaccine (listed in section 6)
• you have ever had an allergic reaction to diphtheria toxoid (a substance used in several vaccines)
• you have an illness with high fever. However, a mild infection with low-grade fever or of the upper respiratory tract (for example, a cold) is not in itself a reason to delay vaccination.

Warnings and precautions

Talk to your doctor or nurse before you or your child are given Menveo if you (or your child):

• Have a weakened immune system. There is limited information on the effectiveness of Menveo in people with a weakened immune system due to immunosuppressive medications, HIV infection, or other possible causes. It is possible that the effectiveness of Menveo may be reduced in such individuals.
• Have hemophilia or any other condition that impairs your blood's ability to clot properly. This includes people receiving treatment with anticoagulants.
• Are receiving treatment that blocks the part of the immune system known as complement activation, such as eculizumab. Even if you have been vaccinated with Menveo, you still have an increased risk of invasive disease caused by the bacterium Neisseria meningitidis groups A, C, W-135, and Y.

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

This vaccine only protects against meningococcal bacteria of serogroups A, C, W-135, and Y. It does not protect against other types of meningococcal bacteria not belonging to serogroups A, C, W-135, and Y, or against other causes of meningitis or septicemia (blood poisoning).

As with any vaccine, it is possible that Menveo may not protect 100% of vaccinated individuals.

If you or your child received a dose of Menveo more than one year ago and remain at particular risk of exposure to meningococcal bacteria of serogroups A, C, W-135, and Y, a booster dose may be considered to maintain protection. Your doctor will advise you whether you should receive a booster dose and when.

Use of Menveo with other medicines

Inform your doctor or nurse if you are using, have recently used, or might need to use any other medicines.

Menveo may be given at the same time as other vaccines, but it is preferable that other vaccines are injected into the arm opposite to the one used for Menveo injection.

These vaccines include: tetanus, reduced diphtheria, and acellular pertussis (Tdpa), human papillomavirus (HPV), yellow fever, typhoid fever (Vi polysaccharide), Japanese encephalitis, rabies, hepatitis A and B, and meningococcal group B (Bexsero).

There may be a reduced effect of Menveo if it is administered to people taking medicines that suppress the immune system.

Separate injection sites must be used if more than one vaccine is administered at the same time.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before receiving this medicine. Your doctor or nurse may still recommend that you receive Menveo if you are at high risk of infection with meningococcal bacteria of serogroups A, C, W-135, and Y.

Driving and using machines

It is unlikely that Menveo will affect your ability to drive, ride a bicycle, or use machinery. However, if you do not feel well, do not drive, ride a bicycle, or use any machinery.

Menveo contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per dose; this is essentially "sodium-free".

3. How to use Menveo

Your doctor or nurse will administer Menveo to you or your child.

The vaccine is usually injected into the muscle of the upper arm (deltoid) in children (from 2 years of age), adolescents, and adults. Your doctor or nurse will take care to ensure that the vaccine is not administered into a blood vessel and that it is injected into the muscle, not the skin.

A single injection (0.5 ml) of the vaccine will be given to children (from 2 years of age), adolescents, and adults.

The safety and efficacy of Menveo have not yet been established in children under 2 years of age. Data available for subjects aged 56–65 years are limited, and no data are available for individuals over 65 years of age.

Inform your doctor if you have previously received an injection of Menveo or another meningococcal vaccine. Your doctor will advise you whether you need another injection of Menveo.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the most frequently reported side effects during clinical trials lasted only one to two days and were usually not serious.

The following side effects may occur after receiving Menveo:

Very common (may affect more than 1 in 10 people): headache, muscle pain, irritability (in children aged 2 to 10 years), general feeling of being unwell, pain at injection site, redness at injection site (≤ 50 mm), swelling or hardening at injection site (≤ 50 mm)

Common (may affect up to 1 in 10 people): fever (≥ 38 °C), vomiting (in children aged 2 to 10 years), diarrhoea (in children aged 2 to 10 years), nausea, chills, changes in eating habits (in children aged 2 to 10 years), drowsiness (in children aged 2 to 10 years), redness at injection site (> 50 mm), swelling or hardening at injection site (> 50 mm)

Uncommon (may affect up to 1 in 100 people): allergic reactions, fainting, dizziness (in adolescents aged 11 years and adults), loss of balance, swollen lymph nodes, itching at injection site, swelling at injection site

Rare (may affect up to 1 in 1,000 people): seizures (fits), including those associated with fever, skin infection at injection site, swelling of the injected limb

Frequency not known (cannot be estimated from available data): severe allergic reactions, presenting with the following symptoms: swelling of the lips, mouth and throat (which may cause difficulty swallowing), difficulty breathing with wheezing (noises when breathing) or cough, rash and swelling of the hands, feet and ankles, loss of consciousness, very low blood pressure

If a severe allergic reaction occurs, contact your doctor immediately or go straight to the nearest emergency department/bring your child to the nearest emergency department, as urgent medical attention may be required.

Reporting of side effects

If you experience any type of side effect, talk to your doctor, pharmacist or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them 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. Storage of Menveo

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2°C and 8°C). Do not freeze. Keep vials in the original packaging to protect them from light.

Stability data indicate that the unopened vaccine is stable for up to 24 hours when stored at 25°C. After this period, the liquid Menveo must be used or discarded. This information is intended solely to guide healthcare professionals in the event of a temporary temperature excursion.

Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will dispose of this medicine appropriately. This helps protect the environment.

6. Contents of the pack and other information

Composition of Menveo

One dose (0.5 mL) contains:

• Meningococcal group A oligosaccharide 10 micrograms

Conjugated to CRM197 protein from Corynebacterium diphtheriae 16.7 to 33.3 micrograms

• Meningococcal group C oligosaccharide 5 micrograms

Conjugated to CRM197 protein from Corynebacterium diphtheriae 7.1 to 12.5 micrograms

• Meningococcal group W-135 oligosaccharide 5 micrograms

Conjugated to CRM197 protein from Corynebacterium diphtheriae 3.3 to 8.3 micrograms

• Meningococcal group Y oligosaccharide 5 micrograms

Conjugated to CRM197 protein from Corynebacterium diphtheriae 5.6 to 10.0 micrograms

The other components (excipients) are: sodium chloride, monosodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate dihydrate, and water for injections.

See section 2 “Menveo contains sodium”.

Appearance of the product and contents of the pack

Menveo is an injectable solution.

The solution is clear and colourless.

The solution is supplied in a vial (type I glass) with a bromobutyl rubber stopper coated with ethylene tetrafluoroethylene (ETFE) and a pink security cap.

One dose (1 vial) or 10 doses (10 vials) per pack. Each vial contains one 0.5 mL dose.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

GSK Vaccines S.r.l.

Via Fiorentina 1, 53100 – Siena,

Italy.

Manufacturer:

GSK Vaccines S.r.l.

Bellaria Rosia, 53018 Sovicille (Siena),

Italy.

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Date of the most recent review of this leaflet:

Other sources of information

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

This 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:

The vaccine is a ready-to-use injectable solution.

Visually inspect the vaccine before administration.

The vaccine is a clear, colourless, liquid solution, essentially free from visible particles. Do not administer the vaccine if any foreign particles and/or physical changes are observed.

Use an appropriate syringe and needle to withdraw the entire contents of the vial.

Before injection, replace the needle with one suitable for administration. Ensure that there are no air bubbles in the syringe before injecting the vaccine.

Disposal of unused medicine and of all materials that have come into contact with it should be carried out in accordance with local regulations.

Stability data indicate that the unopened vaccine is stable for up to 24 hours when stored at 25°C. After this period, Menveo liquid must be used or discarded. This information is intended to guide healthcare professionals only in the event of a temporary temperature excursion.