Prospect: information for the user

Menveo powder and injectable solution

Conjugated vaccine against meningococcal serogroups A, C, W-135 and Y

Read this prospect carefully before you or your child is administered this medication,because it contains important information for you

• Keep this prospect, you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This vaccine has been prescribedonlyto you or your child.
• Ifyou experienceadverse effects, consult your doctor, pharmacist or nurse, evenifthey do not appearin this prospect. See section4.

1.What Menveo is and for what it is used

2.What you need to know before Menveo is administered to you or your child

3.How to use Menveo

4.Possible adverse effects

5.Storage of Menveo

6.Contents of the package and additional information

Menveo is a vaccine that is usedfor active immunization of children (from the age of2years old), adolescents and adults who are at risk of exposure to a bacterium calledNeisseria meningitidisof serogroups A, C, W-135and Y, in order to prevent invasive diseases.The vaccine works in such a way that it makes your body generate its own protection (antibodies) against these bacteria.

The bacteria of serogroups A, C, W-135and Y ofNeisseria meningitidiscan cause serious infections that, even, can put the patient's life at risk, 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 (oryour child) will need to receive other vaccines that will protect you from diphtheria when the time comes or if yourdoctor advises it.

Do not administer Menveo to you or your child if:

• You or your child have ever had an allergic reaction to the active ingredients or to 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 disease with high fever. However, a mild infection with high fever or upper respiratory tract infection (such as a cold) is not in itself a reason to delay vaccination.

Warnings and precautions

Consult your doctor or nurse before Menveo is administered to you or your child if you (or your child):

• Have a weakened immune system. There is little information about the effectiveness of Menveo in people whose immune system is weakened due to the use of immunosuppressive medications, HIV infection, or other possible causes. There is a possibility that the effectiveness of Menveo may be reduced in such individuals.
• Have hemophilia or any other condition that prevents your blood from clotting properly. This is the case for people who are under 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 a higher risk of invasive disease caused by the Neisseria meningitidis bacteria groups A, C, W-135, and Y.

You may experience dizziness, feeling of loss of consciousness, or other reactions associated with stress as a response to any injection with a needle. Inform your doctor or nurse if you have had such a reaction in the past.

This vaccine only has the ability to protect against meningococcal bacteria of serogroups A, C, W-135, and Y. It does not protect against other types of meningococcal bacteria that are not of 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 all 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 if you should receive a booster dose and when to do so.

Use of Menveo with other medications

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

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

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

There may be a reduction in the effect of Menveo in the case of administration to individuals taking medications that inhibit the immune system.

It is necessary to administer the injection in different locations in the case of administration of more than one vaccine at the same time.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before this medication is administered. It is possible that your doctor or nurse will still recommend the administration of Menveo if you are at high risk of infection with meningococcal bacteria of serogroups A, C, W-135, and Y.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery. A few cases of dizziness have been described after vaccination. This may temporarily affect the ability to drive or operate machinery.

Menveo contains

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

This medication contains less than 39 mg (1 mmol) of potassium per dose; it is essentially "potassium-free."

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

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

A single injection (0.5 ml) of the vaccine will be administered 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. Available data for subjects aged 56-65 years are limited, and there are no data for individuals over 65 years.

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

For more information about vaccine reconstitution, refer to the section dedicated to healthcare professionals or doctors located at the end of this leaflet.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Generally, the most common side effects that were described during clinical trials lasted only one to two days and were not normally severe.

In children (aged 2 to 10 years), the side effects reported during clinical trials are described below.

Very common (may affect more than 1 in 10): drowsiness, headache, irritability, general feeling of being unwell, pain at the injection site, redness at the injection site (≤ 50 mm), induration at the injection site (≤ 50 mm)

Common (may affect up to 1 in 10): 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 induration at the injection site (> 50 mm)

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

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

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

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

Rare: dizziness, itching at the injection site

The side effects reported during commercial use include:

Rare: swollen lymph nodes.

Unknown frequency: allergic reactions, which may include severe swelling of the lips, mouth, and throat (which may cause difficulty swallowing), difficulty breathing with wheezing (breathing sounds) or cough, skin rash and swelling of the hands, feet, and ankles, loss of consciousness, very low blood pressure; seizures, including those associated with fever; alteration of balance; fainting; skin infection at the injection site; swelling at the injection site, including extensive swelling of the injected limb.

If a severe allergic reaction occurs, inform your doctor immediately or go to the nearest emergency service with your child, as they may need urgent medical assistance.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the national notification system included in the Annex V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keepthis medicationout of sightand out of reachof children.

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

Store in the refrigerator (between2°C and8°C). Do not freeze. Store the vials in the original packaging to protect them from light.

After reconstitution, the product must be used immediately. However, chemical and physical stability after reconstitution has been demonstrated for8hours below25°C.

Medicines should not be disposed of through drains or in the trash. Your doctor or nurse will be responsible for disposing of this medication. This will help protect the environment.

Composition of Menveo

A dose (0.5ml of reconstituted vaccine) contains:

The active principles are:

(Original content of the powder)

• Meningococcal oligosaccharide group A10micrograms

Conjugated with CRM197protein fromCorynebacterium diphtheriae16.7to33.3micrograms

(Original content of the injectable solution)

• Meningococcal oligosaccharide group C5micrograms

Conjugated with CRM197protein fromCorynebacterium diphtheriae7.1to12.5micrograms

• Meningococcal oligosaccharide group W-1355micrograms

Conjugated with CRM197protein fromCorynebacterium diphtheriae3.3to8.3micrograms

• Meningococcal oligosaccharide group Y5micrograms

Conjugated with CRM197protein fromCorynebacterium diphtheriae5.6to10.0micrograms

The other components (excipients) are:

In the powder: potassium dihydrogen phosphate and sucrose.

In the injectable solution:cloride of sodium, sodium dihydrogen phosphate monohydrate, sodium hydrogen phosphate dihydrate and water for injection (see also the end of Section2).

Appearance of the product and contents of the package

Menveo consists of a powder and an injectable solution.

Each dose of Menveo is supplied with:

• 1Vial containing the conjugated lyophilized MenA component in the form of a white to off-white powder.
• 1Vial containing the conjugated liquid MenCWY component in the form of a transparent solution.
• Package size of one dose (2vials), five doses (10vials) or ten doses (20 vials).It may only be marketed in some package sizes.

The contents of the two different vials (MenA powder and MenCWY solution) must be mixed beforethe vaccination, resulting in1dose of0.5ml.

Marketing authorization holder and responsible for manufacturing

Marketing authorization holder:

GSK Vaccines S.r.l. –

Via Fiorentina1,53100– Siena,

Italy.

Responsible for manufacturing:

GSK Vaccines S.r.l.

Bellaria Rosia,53018Sovicille (Siena),

Italy.

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:

Other sources of information

The detailed 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.

‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑‑