Menveo powder and solution for solution for injectionMeningococcal Group A, C, W135 and Y conjugate vaccine

Menveo is a vaccine that is used for active immunization of adolescents (from 11 years of age) and adults at risk of exposure to Neisseria meningitidis serogroups A, C, W135 and Y, to prevent invasive disease . The vaccine works by causing your body to make its own protection (antibodies) against these bacteria.

Neisseria meningitidis group A, C, W135 and Y bacteria can cause serious and sometimes life-threatening infections such as meningitis and sepsis (blood poisoning).

Menveo cannot cause bacterial meningitis or diphtheria.

Do not use Menveo if you or your child has :

• ever had an allergic reaction to the active substances or any of the other ingredients of Menveo (see Section 6Further Information)
• ever had an allergic reaction to diphtheria toxoid (a substance used in a number of other vaccines)
• an illness with high fever. However, a mild fever or upper respiratory infection (for example cold) itself is not a reason to delay vaccination.

Take special care with Menveo if you (or your child) have:

• Haemophilia or any other problem that may stop your blood from clotting properly, such as persons receiving blood thinners (anticoagulants).

This vaccine can only protect against meningococcal group A, C, W135, and Y bacteria. It cannot protect against other types of meningococcal bacteria other than groups A, C, W135 and Y, or against other causes of meningitis and sepsis (blood poisoning).

Little is known about the effectiveness of Menveo when administered to individuals with weakened immunity due to use of immunosuppressive medications, or HIV infection, and other possible causes. It is possible that the effectiveness of Menveo could be reduced in such individuals.

As with any vaccine, Menveo may not fully protect 100% of those who get the vaccine.

Using other medicines

Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Menveo may be given at the same time as other vaccinations. These include:
Tetanus, Reduced Diphtheria and Acellular Pertussis Vaccine (Tdap), and Human Papillomavirus Vaccine (HPV).

Menveo?s effect could be diminished when administered to individuals who are taking medicines that suppress the immune system.

Other injected vaccines must be given into a different arm from the site of the Menveo injection.

Pregnancy and breast-feeding

If you are pregnant, likely to become pregnant or are breast-feeding, you must tell your doctor before Menveo is given. Your doctor or nurse may still recommend that you receive Menveo if you are at high risk of infection with meningococcal group A, C; W-135 and Y bacteria.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been performed. Dizziness has been very rarely reported following vaccination. This may temporarily affect the ability to drive or use machines.

Important information about some of the ingredients of Menveo

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ?sodium-free?.
This medicinal products contains less than 1 mmol potassium (39 mg) per dose, i.e. essentially ?potassium- free?"

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

The vaccine is usually given into the upper arm muscle (deltoid) for adolescents and adults. Your doctor or nurse will take care to ensure the vaccine is not given into a blood vessel and will make sure that it is injected into muscle and not into the skin.
For adolescents (from 11 years of age) and adults: a single dose (0.5 ml) of the vaccine is recommended.

There are limited data in individuals aged 56-65 and there are no data in subjects aged older than 65 years

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

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

The most common side effects reported during clinical trials usually lasted only one to two days and were not usually severe. The most common side effects that were reported during clinical trials are listed below.

Very common (affects more than 1 user in 10): headache, nausea, injection site pain, injection site redness(? 50 mm), injection site firmness or swelling (? 50 mm), injection site itching, malaise

Common (affects 1 to 10 users in 100): rash, injection site redness (> 50 mm), injection site firmness or swelling (> 50 mm), fever ? 38°C, chills

Uncommon (affects 1 to 10 users in 1,000): dizziness

Keep out of the reach and sight of children.

Do not use Menveo after the expiry date which is stated on the outer carton after 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 in order to protect from light.

After reconstitution, the product should be used immediately. However, chemical and physical stability after reconstitution was 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. These measures will help to protect the environment.

What Menveo contains

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

(Originally contained in the powder)

• Meningococcal group A oligosaccharide 10 microgramsConjugated to Corynebacterium diphtheriae CRM 197 protein 16.7 to 33.3 micrograms

(Originally contained in the solution)

• Meningococcal group C oligosaccharide 5 microgramsConjugated to Corynebacterium diphtheriae CRM 197 protein 7.1 to 12.5 micrograms
• Meningococcal group W135 oligosaccharide 5 microgramsConjugated to Corynebacterium diphtheriae CRM 197 protein 3.3 to 8.3 micrograms
• Meningococcal group Y oligosaccharide 5 microgramsConjugated to Corynebacterium diphtheriae CRM 197 protein 5.6 to 10.0 micrograms

The other ingredients are

In the powder: potassium dihydrogen phosphate and sucrose.

In the solution: sodium chloride, sodium dihydrogen phosphate monohydrate, sodium hydrogen phosphate dihydrate, and water for injection (See also end of Section 2).

What Menveo looks like and contents of the pack

Menveo is a powder and a solution for injection.
Each dose of Menveo is supplied as a:

• 1 Vial containing the MenA Lyophilised Conjugate Component as a white to off-white powder
• 1 Vial containing the MenCWY Liquid Conjugate Component as clear solution
• Pack size of one dose (2 vials) or five doses (10 vials). Not all pack sizes may be marketed.

The contents of the two components (vial and vial) are to be mixed prior to vaccination providing 1 dose of 0.5 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:Novartis Vaccines and Diagnostics S.r.l., Via Fiorentina 1, 53100 Siena, Italy
Manufacturer: Novartis Vaccines and Diagnostics S.r.l., Bellaria-Rosia, 53018 Sovicille (Siena), Italy

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

BelgiëBelgiqueBelgien Novartis Vaccines and Diagnostics S.r.l. TélTel 39 0577 243638 ItaliëItalieItalien LuxembourgLuxemburg Novartis Vaccines and Diagnostics S.r.l. TélTel 39 0577 243638 ItalieItalien

Novartis Vaccines and Diagnostics S.r.l. Te. 39 0577 243638 Magyarország Novartis Vaccines and Diagnostics Magyarországi Kereskedelmi Képviselet Bartók Béla út 43-47. H-1114 Budapest Tel. 36 1279 1829

Malta Novartis Vaccines and Diagnostics S.r.l. Tel 39 0577 243638 L-Italja eská republika Novartis s.r.o. Vaccines Diagnostics Gemini B Na Pankráci 1724129 140 00 Prague 4 Czech Republic 420 225 775 111

Danmark Novartis Vaccines and Diagnostics S.r.l. Tlf 39 0577 243638 Italien Nederland Novartis Vaccines and Diagnostics S.r.l. Tel 39 0577 243638 Italië

Deutschland Novartis Vaccines and Diagnostics GmbH Tel 49 6421 39 7798 Norge Novartis Vaccines and Diagnostics S.r.l. Tlf 39 0577 243638 Italia

Österreich Novartis Pharma GmbH Tel 43 1 86 6570 Eesti Novartis Vaccines and Diagnostics S.r.l. Tel 39 0577 243638 Itaalia

Novartis Vaccines and Diagnostics S.r.l. 39 0577 243638 Polska Novartis Poland Sp. z o.o. Al. W. Witosa 31 00-710 Warszawa Tel. 48 22 550-88-88

España Novartis Vaccines and Diagnostics, S.L. Gran Via de les Corts Catalanes 764 08013 Barcelona tel 34 93.306.42.00 Portugal Novartis Farma - Produtos Farmacêuticos, S.A. Rua do Centro Empresarial, Edifício 8 Quinta da Beloura 2710-444 Sintra Tel 351 21 000 8600

România Novartis Vaccines and Diagnostics S.r.l. Tel 39 0577 243638 Italia France Novartis Vaccines and Diagnostics SAS 10 rue Chevreul 92 150 Suresnes France tél 00 33 1 55 49 00 30

Ireland Novartis Vaccines and Diagnostics S.r.l. Tel 39 0577 243638 Italy Slovenija Novartis Vaccines and Diagnostics S.r.l. Tel 39 0577 243638 Italija

Ísland Novartis Vaccines and Diagnostics S.r.l. Sími 39 0577 243638 Ítalía Slovenská republika Novartis Slovakia s.r.o. Galvaniho 15A 821 08 Bratislava Slovenská republika Tel 421 2 5070 6111

SuomiFinland Novartis Vaccines and Diagnostics S.r.l. PuhTel 39 0577 243638 ItaliaItalien Italia Novartis Vaccines and Diagnostics s.r.l. Via Fiorentina 1 53100 Siena Tel 800867121

Novartis Vaccines and Diagnostics S.r.l. 39 0577 243638 Sverige Novartis Vaccines and Diagnostics S.r.l. Tel 39 0577 243638 Italien

Latvija Novartis Vaccines and Diagnostics S.r.l. Tel 39 0577 243638 Itlija United Kingdom Novartis Vaccines and Diagnostics Ltd Gaskill Road Speke Liverpool L24 9GR Tel 440 845 745 1500 Lietuva Novartis Vaccines and Diagnostics S.r.l. Tel 39 0577 243638 Italija

This leaflet was last approved in (MM/YYYY)

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The following information is intended for medical or healthcare professionals only:

Reconstitution of the vaccine

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

Using a syringe and suitable needle (21G, 1 1/2??), withdraw the entire contents of the vial of solution and inject into the vial of powder to reconstitute the MenA conjugate component.

Invert and shake the vial vigorously and then withdraw 0.5 ml of reconstituted product. Please note that it is normal for a small amount of liquid to remain in the vial following withdrawal of the dose. Prior to injection, change the needle with one suitable for the administration (25G, 1??). Ensure that no air bubbles are present in the syringe before injecting the vaccine.

Following reconstitution, the vaccine is a clear, colourless solution, free from visible foreign particles. In the event of any foreign particulate matter and/or variation of physical aspect being observed, discard the vaccine.

Menveo is given as an intramuscular injection, preferably into the deltoid muscle.

Any unused product or waste material should be disposed of in accordance with local requirements.