Menveo: detailed information

Package leaflet: Information for the user

Menveo powder and solution for injectable solution

Meningococcal conjugate vaccine group A, C, W-135 and Y
Please read this leaflet carefully before this medicine is administered to you or your child 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 side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Menveo is and what it is used for
What you need to know before receiving Menveo
How to use Menveo
Possible side effects
How to store Menveo
Contents of the pack and other information

1. What Menveo is and what it is used for

Menveo is a vaccine used for active immunisation of children (from 2 years of age),
adolescents and adults at risk of exposure to serogroups A, C, W-135 and Y of a bacterium called
Neisseria meningitidis to prevent the onset of invasive diseases. The vaccine works by triggering
the body's protective response (antibodies) against these bacteria.
Bacteria of Neisseria meningitidis belonging to groups A, C, W-135 and Y can cause
serious and sometimes life-threatening infections such as meningitis and sepsis (blood poisoning).
Menveo cannot cause bacterial meningitis. The vaccine contains a protein (called CRM )
derived from the bacterium that causes diphtheria. Menveo does not protect against diphtheria. This means
that you (or the child) will need to receive other vaccinations to be protected against diphtheria when
these are necessary or recommended by a doctor.

2. What you should know before receiving Menveo

Do not use Menveo if the person to be vaccinated

has had an allergic reaction to the active substances or to any component of this vaccine (listed in section 6)
has had an allergic reaction to diphtheria toxoid (a substance used in several other vaccines)
has an illness with high fever. However, a mild febrile illness and/or an upper respiratory tract infection (e.g. a cold) alone are not sufficient reasons to delay vaccination.

Warnings and precautions:
Tell the doctor or nurse before Menveo is administered if you or your child:

has a weakened immune system. There is limited data on the effectiveness of Menveo when given to individuals whose immune system is weakened due to immunosuppressive drugs, HIV infection, or other possible causes. In these individuals, the effectiveness of Menveo may be reduced.
has haemophilia or any other condition that may impair proper blood clotting, such as patients receiving anticoagulant therapy.
is receiving treatment that blocks the part of the immune system known as complement activation, such as eculizumab. Even after vaccination with Menveo, there remains an increased risk of disease caused by Neisseria meningitidis bacteria of 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. Speak to the doctor or nurse if you have previously experienced such reactions.
This vaccine protects only against bacteria of meningococcal groups A, C, W-135 and Y. It cannot protect against other types of meningococcal bacteria different from groups A, C, W-135 and Y, or against other agents causing meningitis and sepsis (blood poisoning).
As with other vaccines, Menveo may not protect 100% of individuals who receive the vaccine.
A booster dose may be considered to maintain protection if the vaccinated person received a dose of Menveo more than one year ago and remains at particular risk of exposure to group A meningococcal bacteria. Your doctor will advise you whether and when to receive a booster dose.
Other medicines and Menveo
Inform the doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Menveo can be administered at the same time as other vaccines, but any other vaccines should preferably be injected into a different arm from the injection site of Menveo.
These include the following vaccines: tetanus and diphtheria, acellular pertussis vaccine with reduced antigen content (Tdap), human papillomavirus (HPV) vaccine, yellow fever vaccine, typhoid fever vaccine (Vi polysaccharide), Japanese encephalitis vaccine, rabies vaccine, hepatitis A and B vaccine, and group B meningococcal vaccine (Bexsero).
The effect of Menveo may be reduced if administered to individuals taking medicines that suppress the immune system.
If multiple vaccines are administered simultaneously, separate injection sites must be used.
Pregnancy, breastfeeding and fertility
Inform the doctor before taking this medicine if you are pregnant, breastfeeding, suspect you may be pregnant, or are planning a pregnancy. The doctor or nurse may still recommend administration of Menveo if the risk of infection with meningococcal bacteria of groups A, C, W-135 and Y is high.
Driving and using machines
No studies on the ability to drive vehicles and use machines have been conducted. Very rare cases of dizziness have been reported following vaccination. The ability to drive vehicles and use machines may be temporarily impaired.
Menveo contains
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’.
This medicine contains less than 1 mmol (39 mg) of potassium per dose, i.e. essentially ‘potassium-free’.

3. How to use Menveo

Menveo will be administered to you or the child by a doctor or nurse.
The vaccine is normally injected into the muscle of the upper arm (deltoid) in children (from 2 years of age), adolescents, and adults. The doctor or nurse will take care not to inject the vaccine into a blood vessel and will ensure that it is injected into the muscle and not into the skin.
For children (from 2 years of age), adolescents, and adults: a single injection (0.5 mL) will be given.
The safety and efficacy of Menveo in children under 2 years of age have not yet been established. Data in subjects aged between 56 and 65 years are limited, and there are no data available for subjects over 65 years of age.
Inform your doctor if you have previously received an injection of Menveo or of another meningococcal vaccine. Your doctor will advise you whether you need another dose of Menveo.
For information on vaccine reconstitution, see the section for healthcare professionals at the end of this leaflet.
If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The most commonly reported side effects during clinical studies generally lasted only from one to two days and were generally not severe.
In children (aged between 2 and 10 years), the side effects reported during clinical studies are listed below.
Very common (may affect more than 1 in 10 people): drowsiness, headache, irritability, feeling unwell, injection site pain, injection site redness (≤50 mm), injection site swelling (≤50 mm)
Common (may affect up to 1 in 10 people): change in eating habits, nausea, vomiting, diarrhoea, rash, muscle pain, joint pain, chills, fever ≥38°C, injection site redness (>50 mm), and injection site swelling (>50 mm)
Uncommon (may affect up to 1 in 100 people): injection site itching

In adolescents (from 11 years of age) and adults, the most commonly reported side effects during clinical studies are listed below.
Very common: headache, nausea, injection site pain, injection site redness (≤50 mm), injection site swelling (≤50 mm), muscle pain, feeling unwell
Common: rash, injection site redness (>50 mm), injection site swelling (>50 mm), joint pain, fever ≥38°C, chills
Uncommon: dizziness, injection site itching

Side effects reported after the marketing of Menveo include:
Rare: swollen lymph nodes
Not known: allergic reactions which may include severe swelling of the lips, mouth, or throat (which may cause difficulty swallowing), difficulty breathing with wheezing or coughing, rash, swelling of the hands, feet and ankles, loss of consciousness, very low blood pressure; seizures (convulsions), including fever-related seizures; balance disorders; fainting; skin infection at the injection site; swelling at the injection site, including extensive swelling of the limb where the injection was given.

If a severe allergic reaction occurs, contact your doctor immediately or go/take your child to the Emergency Department, as urgent medical care may be required.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. 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. How to store Menveo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton after the word "Exp". The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the vials in the outer carton to protect the medicine from light.
The product should be used immediately after reconstitution. However, chemical and physical stability has been demonstrated for 8 hours after reconstitution at a temperature below 25°C.
Medicines must not be disposed of via wastewater or household waste. Your doctor or nurse will dispose of the medicine appropriately. This will help protect the environment.

6. Package contents and other information

What Menveo contains
One dose (0.5 mL of reconstituted vaccine) contains:
The active substances are:
(originally contained in the powder)

meningococcal group A oligosaccharide 10 micrograms conjugated to Corynebacterium diphtheriae CRM protein 16.7 to 33.3 micrograms

(originally contained in the solution)

meningococcal group C oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM protein 7.1 to 12.5 micrograms
meningococcal group W-135 oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM protein 3.3 to 8.3 micrograms
meningococcal group Y oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM protein 5.6 to 10.0 micrograms

The other components (excipients) are:
In the powder: monopotassium phosphate and sucrose.
In the solution: sodium chloride, monosodium hydrogen phosphate monohydrate, disodium hydrogen phosphate dihydrate,
and water for injections (see also the end of section 2).

Description of the appearance of Menveo and package contents
Menveo is a lyophilized powder and an injectable solution.
Each dose of Menveo is supplied as:

1 vial containing the lyophilized conjugate component MenA as a white to off-white powder;
1 vial containing the liquid conjugate component MenCWY as a clear solution;
Pack sizes of 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) must be mixed before vaccination to obtain one 0.5 mL dose.

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 about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals SA / NV GSK Vaccines S.r.l.
Tél/Tel: + 32 10 85 52 00 Tel: +370 80000334

България Luxembourg/Luxemburg
GSK Vaccines S.r.l. GlaxoSmithKline Pharmaceuticals SA/NV
Тел. +359 80018205 Tél/Tel: + 32 10 85 52 00

Česká republika Magyarország
GlaxoSmithKline s.r.o. GSK Vaccines S.r.l.
Tel: + 420 2 22 00 11 11 Tel.: +36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GSK Vaccines S.r.l.
Tlf: + 45 36 35 91 00 Tel: +356 80065004
[email protected]

Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel: +49 (0)89 36044 8701 Tel: + 31 (0)33 2081100
[email protected]

Eesti Norge
GSK Vaccines S.r.l. GlaxoSmithKline AS
Tel: +372 8002640 Tlf: + 47 22 70 20 00

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E GlaxoSmithKline Pharma GmbH.
Tηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (22) 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline GlaxoSmithKline - Produtos Farmacêuticos,
Tél: + 33 (0) 1 39 17 84 44 Lda.
[email protected] Tel: + 351 21 412 95 00
[email protected]

Hrvatska România
GSK Vaccines S.r.l. GSK Vaccines S.r.l.
Tel.: +385 800787089 Tel: +40 800672524

Ireland Slovenija
GlaxoSmithKline (Ireland) Ltd GSK Vaccines S.r.l.
Tel: + 353 (0)1 495 5000 Tel: +386 80688869

Ísland Slovenská republika
Vistor hf. GSK Vaccines S.r.l.
Sími: +354 535 7000 Tel.: +421 800500589

Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: +39 (0)45 7741111 Puh/Tel: + 358 10 30 30 30

Κύπρος Sverige
GSK Vaccines S.r.l. GlaxoSmithKline AB
Τηλ: +357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija United Kingdom (Northern Ireland)
GSK Vaccines S.r.l. GSK Vaccines S.r.l.
Tel: +371 80205045 Tel: +44 (0)800 221 441
[email protected]

This leaflet was last reviewed on (MM/YYYY)

Other sources of information
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 European Medicines Agency website.

The following information is intended exclusively for healthcare professionals:

Reconstitution of the vaccine
Menveo must be prepared for administration by reconstituting the powder with the solution.
The contents of the two vials (MenA powder and MenCWY solution) must be mixed prior to
vaccination to obtain a 0.5 mL dose.
Using a syringe and a suitable needle (21G, 40 mm length or 21G, 1½ inch length), withdraw the
entire contents of the solution vial and inject it into the powder vial to reconstitute the conjugated
MenA component.
Invert the vial and shake 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 vaccine administration. Ensure that no air
bubbles are present in the syringe prior to injecting the vaccine.
After reconstitution, the vaccine is a clear, colourless to pale yellow solution, free from visible
foreign particles. If particulate matter or any change in physical appearance is observed, discard the
vaccine.
Menveo is administered by intramuscular injection, preferably into the deltoid muscle.
Any unused medicine and waste material derived from this medicine must be disposed of in
accordance with local regulations.

Package leaflet: information for the user

Menveo injectable solution

Meningococcal group A, C, W-135 and Y conjugate vaccine
Please read this leaflet carefully before you or your child are administered this medicine as 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 side effects, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

What Menveo is and what it is used for
What you need to know before receiving Menveo
How to use Menveo
Possible side effects
How to store Menveo
Package contents and other information

1. What Menveo is and what it is used for

Menveo is a vaccine used for active immunisation of children (from 2 years of age),
adolescents and adults at risk of exposure to serogroups A, C, W-135 and Y of a bacterium called
Neisseria meningitidis, to prevent the onset of invasive diseases. The vaccine works by triggering
the body's protective response (antibodies) against these bacteria.
Bacteria of Neisseria meningitidis belonging to groups A, C, W-135 and Y can cause serious
and sometimes life-threatening infections such as meningitis and sepsis (blood poisoning).
Menveo cannot cause bacterial meningitis. The vaccine contains a protein (called CRM ) derived
from the bacterium that causes diphtheria. Menveo does not protect against diphtheria. This means
that you (or the child) will need to receive other vaccinations to be protected against diphtheria when
such vaccinations are necessary or recommended by a doctor.

2. What you need to know before receiving Menveo

Do not use Menveo if the person to be vaccinated

has had an allergic reaction to the active substances or to any component of this vaccine (listed in section 6)
has had an allergic reaction to diphtheria toxoid (a substance used in many other vaccines)
has a disease with high fever. However, a mild febrile illness and/or an upper respiratory tract infection (e.g. a cold) alone are not sufficient reasons to delay vaccination.

Warnings and precautions
Tell the doctor or nurse before administration of Menveo if you or your child:

has a weakened immune system. There is limited data on the effectiveness of Menveo when administered to individuals with a weakened immune system due to the use of immunosuppressive medications, HIV infection, or other possible causes. In these individuals, the effectiveness of Menveo may be reduced.
has haemophilia or any other condition that may impair proper blood clotting, such as patients receiving anticoagulant therapy.
is receiving treatment that blocks the part of the immune system known as complement activation, such as eculizumab. Even after vaccination with Menveo, there remains an increased risk of disease caused by Neisseria meningitidis bacteria of groups A, C, W-135 and Y.

Fainting, feeling faint, or other stress-related reactions may occur in response to any needle injection. Please consult your doctor or nurse if you have previously experienced such reactions.
This vaccine only protects against meningococcal bacteria groups A, C, W-135 and Y. It cannot protect against other types of meningococcal bacteria different from groups A, C, W-135 and Y or against other causes of meningitis and sepsis (blood poisoning).
As with other vaccines, Menveo may not protect 100% of individuals who receive the vaccine.
A booster dose may be considered to maintain protection if the vaccinated person received a dose of Menveo more than one year ago and remains at particular risk of exposure to meningococcal group A bacteria. Your doctor will advise you whether and when to receive a booster dose.

Other medicines and Menveo
Tell the doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Menveo can be administered at the same time as other vaccines, but any additional vaccines should preferably be injected into a different arm from the Menveo injection site.
These include the following vaccines: tetanus and reduced diphtheria toxoid and reduced acellular pertussis (Tdap) vaccine, human papillomavirus (HPV) vaccine, yellow fever vaccine, typhoid fever vaccine (Vi polysaccharide), Japanese encephalitis vaccine, rabies vaccine, hepatitis A and B vaccines, and meningococcal group B vaccine (Bexsero).
The effect of Menveo may be reduced if administered to individuals taking medicines that suppress the immune system.
If multiple vaccines are administered simultaneously, separate injection sites must be used.

Pregnancy, breastfeeding and fertility
Inform the doctor before taking this medicine if you are pregnant, breastfeeding, suspect you may be pregnant, or are planning a pregnancy. The doctor or nurse may still recommend administration of Menveo if the risk of infection with meningococcal bacteria of groups A, C, W-135 and Y is high.

Driving and using machines
No studies have been conducted on the ability to drive vehicles or use machinery. Very rare cases of dizziness have been reported after vaccination. The ability to drive vehicles and use machinery may be temporarily impaired.

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

3. How to use Menveo

Menveo will be administered to you or your child by a doctor or nurse.
The vaccine is usually injected into the muscle of the upper arm (deltoid) in children (from 2 years of age), adolescents, and adults. The doctor or nurse will take care not to inject the vaccine into a blood vessel and will ensure that it is injected into the muscle and not under the skin.
For children (from 2 years of age), adolescents, and adults: a single injection (0.5 mL) will be given.
The safety and efficacy of Menveo in children under 2 years of age have not yet been established. Data in subjects aged between 56 and 65 years are limited, and there are no data available for subjects over 65 years of age.
Inform your doctor if you have previously received an injection of Menveo or of another meningococcal vaccine. Your doctor will advise you whether you need another dose of Menveo.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

In children (aged between 2 and 10 years), the side effects reported during clinical studies are listed below.
Very common (may affect more than 1 in 10 people): drowsiness, headache, irritability, feeling unwell, injection site pain, injection site redness (≤50 mm), injection site hardening (≤50 mm)
Common (may affect up to 1 in 10 people): change in eating habits, nausea, vomiting, diarrhoea, rash, muscle pain, joint pain, chills, fever ≥38°C, injection site redness (>50 mm), and injection site hardening (>50 mm)
Uncommon (may affect up to 1 in 100 people): injection site itching

In adolescents (from 11 years of age) and adults, the most commonly reported side effects during clinical studies are listed below.
Very common: headache, nausea, injection site pain, injection site redness (≤50 mm), injection site hardening (≤50 mm), muscle pain, feeling unwell
Common: rash, injection site redness (>50 mm), injection site hardening (>50 mm), joint pain, fever ≥38°C, chills
Uncommon: dizziness, injection site itching

Side effects reported after marketing authorization of Menveo include:
Rare: swollen lymph nodes
Not known: allergic reactions which may include severe swelling of the lips, mouth, throat (which may cause difficulty swallowing), difficulty breathing with wheezing or coughing, rash, swelling of the hands, feet and ankles, loss of consciousness, very low blood pressure; seizures (convulsions), including fever-related seizures; balance disorders; fainting; skin infection at the injection site; swelling at the injection site, including extensive swelling of the limb where the injection was given.

If a severe allergic reaction occurs, contact your doctor immediately or go/take your child to the Emergency Department, as urgent medical care may be required.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Menveo

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box after the word "Exp". The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze. Keep the vials in the outer cardboard box to protect the medicine from light.
Stability data indicate that the vaccine, prior to opening, remains stable for up to 24 hours at a temperature of 25°C. At the end of this time period, liquid Menveo must be used or discarded. This information is intended to guide healthcare professionals only in the case of a temporary temperature excursion.
Medicines should not be disposed of via wastewater or household waste. Your doctor or nurse will take care of the proper disposal of the medicine. This will help protect the environment.

6. Package contents and other information

What Menveo contains
One dose (0.5 mL) contains:

Meningococcal group A oligosaccharide 10 micrograms conjugated to Corynebacterium diphtheriae CRM protein 16.7 to 33.3 micrograms
Meningococcal group C oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM protein 7.1 to 12.5 micrograms
Meningococcal group W-135 oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM protein 3.3 to 8.3 micrograms
Meningococcal group Y oligosaccharide 5 micrograms conjugated to Corynebacterium diphtheriae CRM protein 5.6 to 10.0 micrograms

The other components (excipients) are: sodium chloride, monohydrate sodium dihydrogen phosphate,
disodium hydrogen phosphate dihydrate, and water for injections.
See section 2 “Menveo contains sodium”.

Description of Menveo 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 removable pink cap.
One dose (1 vial) or ten doses (10 vials) per pack. Each vial contains a 0.5 mL dose.
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:

België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals s.a./n.v. GSK Vaccines S.r.l.
Tél/Tel: + 32 (0) 10 85 52 00 Tel: +370 80000334

България Luxembourg/Luxemburg
GSK Vaccines S.r.l. GlaxoSmithKline Pharmaceuticals s.a./n.v.
Тел. +359 80018205 Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 52 00