MENVEO INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Menveo injectable solution

Meningococcal conjugate vaccine against serogroups A, C, W-135 and Y

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 further questions, ask your doctor, pharmacist or nurse.
• This vaccine has been prescribed for you or your child only. Do not pass it on to others.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is Menveo and what is it 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. Storage of Menveo
6. Contents of the pack and other information

1. What is Menveo and what is it used for

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

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

Menveo cannot cause meningococcal meningitis. This vaccine contains a protein (called CRM197) from the bacterium that causes diphtheria. Menveo does not protect against diphtheria. You (or your child) will need to receive other vaccines to protect against diphtheria when the time comes or if your doctor advises it.

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

Do not give Menveo to you or your child if:

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

Warnings and precautions

Tell 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 weakened immune systems due to immunosuppressive therapy, HIV infection or other possible causes. The effectiveness of Menveo may be reduced in these individuals.
• have haemophilia or any other condition that prevents your blood from clotting properly. This is the case for people undergoing treatment with anticoagulants.
• are receiving treatment that blocks part of the immune system known as complement activation, such as eculizumab. Even if you have been vaccinated with Menveo, you are still at higher risk of invasive disease caused by Neisseria meningitidis serogroups A, C, W-135 and Y.

Fainting, feeling of loss of consciousness or other stress-related reactions can occur in response to any needle injection. Tell your doctor or nurse if you have had such a reaction in the past.

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 that are not 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 those vaccinated.

If you or your child received a dose of Menveo more than a year ago and are still at particular risk of exposure to meningococcal bacteria of serogroups A, a booster dose may be considered to maintain protection. Your doctor will advise whether you should receive a booster dose and when to do so.

Using Menveo with other medicines

Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.

Menveo can be given at the same time as other vaccines, but it is preferable to administer the injection of other vaccines in the opposite arm to the one used for the Menveo injection.

These vaccines include: tetanus, reduced-dose 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 reduction in the effect of Menveo if it is given to people taking medicines that suppress the immune system.

It is necessary to inject in different locations if more than one vaccine is given at the same time.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice 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

No studies on the effects on the ability to drive and use machines have been performed. A few cases of dizziness have been reported after vaccination. This may temporarily affect the ability to drive or use machines.

Menveo contains sodium

This medicine contains less than 23 mg (1 mmol) of sodium per dose, i.e. it is essentially 'sodium-free'.

3. How to use Menveo

Your doctor or nurse will give you or your child Menveo.

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 make sure that the vaccine is not given into a blood vessel and that it is injected into the muscle and not into 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 in children under 2 years of age have not been established. Data available for subjects aged 56-65 are limited and there are no data for people over 65 years of age.

Tell your doctor if you or your child have previously received an injection of Menveo or another meningococcal vaccine. Your doctor will decide if you need another injection of Menveo.

If you have any further questions on 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 common side effects reported during clinical trials lasted only one to two days and were not usually serious.

In children (2 to 10 years of age), the side effects reported during clinical trials are listed below.

Very common (may affect more than 1 in 10 people): sleepiness, headache, irritability, feeling unwell, pain at the injection site, redness at the injection site (≤ 50 mm), swelling at the injection site (≤ 50 mm)

Common (may affect up to 1 in 10 people): changes in eating habits, nausea, vomiting, diarrhea, skin rash, muscle pain, joint pain, chills, fever ≥ 38°C, redness at the injection site (> 50 mm) and swelling at the injection site (> 50 mm)

Uncommon (may affect up to 1 in 100 people): itching at the injection site

In adolescents (from 11 years of age) and adults, the most common side effects reported during clinical trials are listed below.

Very common: headache, nausea, pain at the injection site, redness at the injection site (≤ 50 mm), swelling at the injection site (≤ 50 mm), muscle pain, feeling unwell

Common: skin rash, redness at the injection site (> 50 mm), swelling at the injection site (> 50 mm), joint pain, fever ≥ 38°C, chills

Uncommon: dizziness, itching at the injection site

Side effects reported during commercial use include:

Rare: swollen lymph nodes.

Frequency not known: allergic reactions, which can include severe swelling of the lips, mouth and throat (which can cause difficulty swallowing), difficulty breathing with wheezing (noisy breathing) or coughing, skin rash and swelling of the hands, feet and ankles, loss of consciousness, very low blood pressure; seizures (convulsions), including those associated with fever; balance disturbance; fainting; skin infection at the injection site; swelling at the injection site, including extensive swelling of the injected limb.

If you experience a severe allergic reaction, seek medical attention immediately or take your child to the nearest emergency room, as you may need urgent medical attention.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse, even if it is possible that they are not listed in this leaflet. 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. Storage of Menveo

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 carton after EXP. The expiry date refers to the last day of the month shown.

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

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

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

6. Contents of the pack and other information

What is in Menveo

One dose (0.5 ml) contains:

• Meningococcal group A oligosaccharide 10 micrograms

Conjugated with Corynebacterium diphtheriae CRM197 protein 16.7 to 33.3 micrograms

• Meningococcal group C oligosaccharide 5 micrograms

Conjugated with Corynebacterium diphtheriae CRM197 protein 7.1 to 12.5 micrograms

• Meningococcal group W-135 oligosaccharide 5 micrograms

Conjugated with Corynebacterium diphtheriae CRM197 protein 3.3 to 8.3 micrograms

• Meningococcal group Y oligosaccharide 5 micrograms

Conjugated with Corynebacterium diphtheriae CRM197 protein 5.6 to 10.0 micrograms

The other ingredients are: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate and water for injections.

See section 2 "Menveo contains sodium".

Appearance and packaging

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 safety cap.

One dose (1 vial) or 10 doses (10 vials) per pack. Each vial contains a single dose of 0.5 ml.

Not all 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.

For further information on this medicine, contact the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

Other sources of information

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

The leaflet for this medicine is available in all languages of the European Union/European Economic Area on the European Medicines Agency website.

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This information is intended only for healthcare professionals:

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

Inspect the vaccine visually before administration.

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

Use a suitable syringe and needle to withdraw the entire contents of the vial.

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

Disposal of unused medicine and all materials that have come into contact with it should be done according to local regulations.

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