Menveo uses, dose and side effects

Menveo is a vaccine for active immunization of children (from 2 years of age), adolescents, and adults who are at risk of being exposed to a bacterium called Neisseria meningitides serogroup A, C, W-135 and Y, to prevent invasive disease. The vaccine works by allowing your body to make its protection ( antibodies ) against these bacteria.

The bacterium Neisseria meningitides group A, C, W-135, and Y can cause serious and sometimes life-threatening infections such as meningitis and sepsis.

Menveo cannot cause bacterial meningitis. This vaccine contains a protein (called CRM 197 ) from the bacterium that causes diphtheria. Menveo does not protect against diphtheria. This means that you (or your child) should take other vaccines to protect against diphtheria when needed or when your doctor recommends it.

What you need to know before you or your child receive Menveo

Do not use Menveo if you or your child

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

Warnings and cautions

Talk to your doctor or nurse before you or your child receive Menveo about you or your child

has a weakened immune system. There is not much information about the effect of Menveo when it is given to people with impaired immunity due to immunosuppressive medication, HIV infection or other possible causes. It is possible that Menveo’s effect will be worse for such people
have haemophilia or other problems that can prevent your blood from coagulating properly, for example if you are taking blood thinners (anticoagulants).
receive treatment that inhibits the part of the immune system called complement activation, for example with ekulizumab. Even if you have been vaccinated with Menveo, you will have a persistent increased risk of invasive disease caused by Neisseria meningitidis group A, C, W-135 and Y bacteria.

Fainting, fainting, or other stress-related reactions may occur as a reaction to needle sticking. Tell your doctor or nurse if you have ever experienced this type of reaction.

This vaccine only protects against meningococcal bacteria groups A, C, W-135, and Y. It does not protect against other types of meningococcal bacteria than groups A, C, W-135, and Y or other causes of meningitis or sepsis.

As with all vaccines, 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 being exposed to group A meningococcal bacteria, you may want to consider a booster dose to maintain protection. Your doctor will advise if and when you should receive a booster dose.

Other medicines and Menveo

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 vaccinations, but other injected vaccines should preferably be given in the other arm than the one in which Menveo is injected.

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

The effect of Menveo can be reduced if given to people taking medicines that reduce the immune system.

Separate injection sites must be selected if more than one vaccine is to be administered 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 taking this medicine. Your doctor or nurse may still recommend Menveo if there is an increased risk of infection with meningococcal bacteria groups A, C, W-135, and Y.

Driving and using machines

No studies have been performed on the ability to drive or use machines.

Dizziness has in very rare cases been reported after vaccination. This may temporarily affect the ability to drive or use machines.

Menveo contains

This medicine contains less than 1 mmol sodium (23 mg) per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.

This medicine contains less than 1 mmol potassium (39 mg) per dose, ie essentially ‘potassium’. is next to “potassium-free”.

How to use Menveo

Menveo will be given to you or your child by a doctor or nurse.

The vaccine is normally given in the upper arm muscle (deltoid muscle) for children (from 2 years), adolescents, and adults. Your doctor or nurse will make sure that the vaccine is not given into a blood vessel and that an injection is given into a muscle and not into the skin.

For children (from 2 years), adolescents, and adults: a single (0.5 ml) injection is given.

The safety and efficacy of Menveo in children under 2 years of age have not yet been established.

There is limited data for people between 56 and 65 years and there is no data for people older than 65 years.

Tell your doctor if you have previously received an injection of Menveo or any other meningococcal vaccine. Your doctor will then tell you if you need another injection of Menveo.

For more information on the reconstitution of the vaccine, please read the section for healthcare professionals at the end of this leaflet.

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

Possible side effects

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

The most common adverse reactions reported in clinical trials usually lasted only one or two days and were not normally severe.

The adverse reactions reported in children (2 to 10 years of age) during clinical trials are reported below.

Very common (may affect more than 1 in 10 people): drowsiness, headache, irritability, general malaise, injection site pain, injection site redness (50 mm or less), injection site hardness (50 mm or less).

Common (may affect less than 1 in 10 people): changes in eating habits, nausea, vomiting, diarrhea, rash, muscle aches, joint pain, chills, fever 38 ° C or higher, redness at the injection site (greater than 50 mm), hardness at the injection site ( larger than 50 mm).

Uncommon (may affect less than 1 in 100 people): itching at the injection site.

The most common adverse reactions reported in adolescents (from 11 years of age) and adults during clinical trials are reported below.

Very common: headache, nausea, injection site pain, injection site redness (50 mm or less), injection site hardness (50 mm or less), muscle aches, general malaise.

Common: rash, redness at the injection site (greater than 50 mm), hardness at the injection site (greater than 50 mm), joint pain, fever 38 ° C or higher, chills.

Uncommon: dizziness, itching at the injection site.

Side effects that have been reported after the product became available for sale are:

Rare: enlarged lymph nodes

Not known frequency: allergic reactions which may include severe swelling of the lips, mouth, and throat (which may cause difficulty in swallowing), difficulty in breathing followed by wheezing or coughing, rash and swelling of hands, feet, and ankles, unconsciousness, very low blood pressure, seizures (convulsions) including febrile seizures, balance problems, fainting, skin infection at the injection site, swelling at the injection site, including extensive swelling in the limb where the injection was given.

If a serious allergic reaction occurs, inform your doctor immediately or go to / take your child to the nearest emergency room as emergency care may be needed.

How to store 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 expiration date is the last day of the specified month.

Store in a refrigerator (2 ° C – 8 ° C). Do not freeze. Store the vials in the outer carton.

Sensitive to light.

After reconstitution, the product should be used immediately. However, chemical and physical in-use stability was demonstrated 8 hours after reconstitution at a temperature below 25 ° C.

Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will be responsible for disposing of this medicine. These measures will help to protect the environment.

Contents of the pack and other information

Content declaration

One dose (0.5 ml of the reconstituted vaccine) contains:

The active substances are

(Originally in the powder)
Meningococcal group A oligosaccharide conjugated to Corynebacterium diphtheriae CRM ₁₉₇protein	10 micrograms between 16.7 and 33.3 micrograms
(Originally in the liquid)
Meningococcal group C oligosaccharide conjugated to Corynebacterium diphtheriae CRM ₁₉₇protein	5 micrograms between 7.1 and 12.5 micrograms
Meningococcal group W-135 oligosaccharide conjugated to Corynebacterium diphtheriae CRM ₁₉₇protein	5 micrograms between 3.3 and 8.3 micrograms
Meningococcal group Y oligosaccharide conjugated to Corynebacterium diphtheriae CRM ₁₉₇protein	5 micrograms between 5.6 and 10.0 micrograms

The other ingredients are

In the powder: potassium dihydrogen phosphate and sucrose.

In the liquid: sodium chloride, sodium dihydrogen phosphate monohydrate, sodium hydrogen phosphate dihydrate, and water for injections (see also the end of section 2).

What the medicine looks like and contents of the pack

Menveo is a powder and solvent for solution for injection

Each dose of Menveo is delivered in the form of:

1 Vial containing MenA lyophilized conjugate component as a white or off-white powder
1 Vial containing MenCWY liquid conjugate component as clear solution
Each pack contains one dose (2 vials), five doses (10 vials) or ten doses (20 vials).

Not all pack sizes may be marketed.

The contents of the two components ( vial and vial ) are mixed before vaccination to give a dose of 0.5 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder:

GSK Vaccines Srl,

Via Fiorentina 1, 53100 Siena,

Italy

Manufacturer: