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AstraZeneca

Menveo
meningococcal group A, C, W-135 and Y conjugate vaccine

Package leaflet: Information for the user


Menveo powder and solution for solution for injection

Meningococcal Group A, C, W-135 and Y conjugate vaccine


Read all of this leaflet carefully before you or your child are given this medicine because it contains important information for you.



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: GSK Vaccines S.r.l.,

Via Fiorentina 1, 53100 Siena, Italy


Manufacturer:

GSK Vaccines 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:


België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals SA/NV Tél/Tel: + 32 10 85 52 00

България

GSK Vaccines S.r.l.

Тел. +359 80018205

Lietuva

GSK Vaccines S.r.l. Tel: +370 80000334

Luxembourg/Luxemburg

GlaxoSmithKline Pharmaceuticals SA/NV Tél/Tel: + 32 10 85 52 00


Česká republika GlaxoSmithKline s.r.o. Tel: + 420 2 22 00 11 11

cz.info@gsk.com

Magyarország

GSK Vaccines S.r.l.

Tel.: +36 80088309


Danmark

GlaxoSmithKline Pharma A/S

Tlf: + 45 36 35 91 00

dk-info@gsk.com

Malta

GSK Vaccines S.r.l.

Tel: +356 80065004


Deutschland

GlaxoSmithKline GmbH & Co. KG

Tel: +49 (0)89 36044 8701

de.impfservice@gsk.com

Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081100


Eesti

GSK Vaccines S.r.l. Tel: +372 8002640

Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 00


Ελλάδα

GlaxoSmithKline Μονοπρόσωπη A.E.B.E

Tηλ: + 30 210 68 82 100

Österreich

GlaxoSmithKline Pharma GmbH. Tel: + 43 (0)1 97075 0

at.info@gsk.com


España GlaxoSmithKline, S.A. Tel: + 34 900 202 700

es-ci@gsk.com

Polska

GSK Services Sp. z o.o. Tel.: + 48 (22) 576 9000


France

Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44

diam@gsk.com


Hrvatska

GSK Vaccines S.r.l. Tel.: +385 800787089

Portugal

GlaxoSmithKline - Produtos Farmacêuticos, Lda.

Tel: + 351 21 412 95 00

FI.PT@gsk.com

România

GSK Vaccines S.r.l. Tel: +40 800672524


Ireland

GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 495 5000

Slovenija

GSK Vaccines S.r.l. Tel: +386 80688869


Ísland

Vistor hf.

Sími: +354 535 7000

Slovenská republika GSK Vaccines S.r.l. Tel.: +421 800500589


Italia

GlaxoSmithKline S.p.A. Tel: +39 (0)45 7741 111

Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 10 30 30 30


Κύπρος

GSK Vaccines S.r.l.

Τηλ: +357 80070017


Latvija

GSK Vaccines S.r.l. Tel: +371 80205045

Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00

info.produkt@gsk.com

United Kingdom (Northern Ireland) GSK Vaccines S.r.l.

Tel: +44 (0)800 221 441

customercontactuk@gsk.com


This leaflet was last revised in (MM/YYYY)


This leaflet is available in all EU/EEA languages on the European Medicines Agency website.

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The following information is intended for healthcare professionals only:


Reconstitution of the vaccine


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


The contents in the two different vials (MenA powder and MenCWY solution) are to be mixed prior to vaccination providing 1 dose of 0.5 mL.


Using a syringe and suitable needle (21G, 40 mm length or 21 G, 1 ½ inch length), 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. Ensure that no air bubbles are present in the syringe before injecting the vaccine.


Following reconstitution, the vaccine is a clear, colourless to light yellow 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.