MENVEO POWDER AND SOLUTION FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Menveo Powder and Solution for Solution for Injection

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.

• 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. Do not pass it on to others.
• If you experience 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 further 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 severe infections that can be life-threatening, such as meningitis or septicemia (blood poisoning).

Menveo cannot cause bacterial meningitis. This vaccine contains a protein (called CRM197) from the bacteria that cause diphtheria. Menveo does not protect against diphtheria. Therefore, 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

Menveo must not be given to you or your child if:

• You or your child have 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 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 or upper respiratory tract infection (such as a cold) 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 medication, HIV infection, or other possible causes. The effectiveness of Menveo may be reduced in these individuals.
• Have hemophilia or any other condition that prevents 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 injection with a needle. Tell your doctor or nurse if you have had such a reaction in the past.

This vaccine only protects against meningococcal bacteria from serogroups A, C, W-135, and Y. It does not protect against other types of meningococcal bacteria or 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 a year ago and are still at particular risk of exposure to meningococcal bacteria from serogroups A, C, W-135, and Y, a booster dose may be considered to maintain protection. Your doctor will advise whether you should receive a booster dose and when.

Using Menveo with other medicines

Tell your doctor or nurse if you are using, have recently used, or might use 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 Menveo.

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 administer the injections 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 being given this medicine. Your doctor or nurse may still recommend that you are given Menveo if you are at high risk of infection with meningococcal bacteria from 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

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

This medicine contains less than 39 mg (1 mmol) of potassium per dose; it is therefore considered to be 'potassium-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 been given an injection of Menveo or another meningococcal vaccine. Your doctor will decide whether you need another injection of Menveo.

For more information on reconstitution of the vaccine, see the section for healthcare professionals or doctors at the end of this leaflet.

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 (2-10 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 post-marketing 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 (noises when breathing) or coughing, rash and swelling of the hands, feet, and ankles, loss of consciousness, very low blood pressure; seizures (convulsions), including those associated with fever; balance problems; 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, tell your doctor immediately or go 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. This includes any possible side effects 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 is 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.

After reconstitution, the product should be used immediately. However, the chemical and physical stability after reconstitution has been demonstrated for 8 hours below 25°C.

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. Package Contents and Additional Information

Menveo Composition

A dose (0.5 ml of reconstituted vaccine) contains:

The active ingredients are:

(Original powder content)

• Meningococcal group A oligosaccharide 10 micrograms

Conjugated with CRM197 protein from Corynebacterium diphtheriae16.7 to 33.3 micrograms

(Original liquid solution content)

• Meningococcal group C oligosaccharide 5 micrograms

Conjugated with CRM197 protein from Corynebacterium diphtheriae7.1 to 12.5 micrograms

• Meningococcal group W-135 oligosaccharide 5 micrograms

Conjugated with CRM197 protein from Corynebacterium diphtheriae3.3 to 8.3 micrograms

• Meningococcal group Y oligosaccharide 5 micrograms

Conjugated with CRM197 protein from Corynebacterium diphtheriae5.6 to 10.0 micrograms

The other components (excipients) are:

In the powder: potassium dihydrogen phosphate and sucrose.

In the injectable solution: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium phosphate dihydrate, and water for injectable preparations (see also the end of Section 2).

Product Appearance and Package Contents

Menveo consists of a powder and an injectable solution.

Each dose of Menveo is supplied with:

• 1 vial containing the conjugated MenA component in the form of a white to off-white powder.
• 1 vial containing the conjugated MenCWY component in the form of a clear solution.
• Package size of one dose (2 vials), five doses (10 vials), or ten doses (20 vials). Only certain package sizes may be marketed.

Both contents (from the vial and the other vial) must be mixed before vaccination via1dose of0.5ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of Last Revision of this Leaflet:

Other Sources of Information

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

This leaflet can be found in all languages of the European Union/European Economic Area on the European Medicines Agency website.

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This information is intended solely for healthcare professionals:

Vaccine Reconstitution

Menveo must be prepared for administration by reconstituting the powder with the solution.

The contents of the two different vials (MenA powder and MenCWY solution) must be mixed before vaccination, resulting in 1 dose of 0.5 ml.

Withdraw the entire contents of the vial with the solution using a syringe and a suitable needle (21G, 40 mm in length or 21G, 1 ½ inches in length) and inject it into the vial with the powder to reconstitute the MenA conjugate component.

Invert and shake the vial vigorously, then withdraw 0.5 ml of the reconstituted product.

Note that it is normal for a small amount of liquid to remain in the vial after withdrawal of the dose. Before injection, replace the needle with one suitable for administration. Ensure that there are no air bubbles in the syringe before injecting the vaccine.

After reconstitution, the vaccine is a clear, colorless to slightly yellow solution without visible foreign particles. If any foreign particles or a change in physical appearance are observed, the vaccine must be discarded.

Menveo is administered as an intramuscular injection, preferably in the deltoid muscle.

Any unused vaccine or waste material should be disposed of in accordance with local regulations.