What ZOSTAVAX contains
After reconstitution, 1 dose (0.65 ml) contains:
The active substance is:
Varicella-zoster virus 1, Oka/Merck strain, (live, attenuated) not less than 19400 PFU (plaque-forming units).
1 Produced in human diploid (MRC-5) cells
The other ingredients are:
PowderSucrose, hydrolysed gelatin, sodium chloride, potassium dihydrogen phosphate, potassium chloride, monosodium L-glutamate, anhydrous disodium phosphate, sodium hydroxide (to adjust pH), and urea.
Solvent
Water for injections
What ZOSTAVAX looks like and contents of the pack
The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be reconstituted with the solvent provided with the vial of powder.
The solvent is a clear and colourless liquid. Before mixing with the solvent, the powder is a white to off-white compact crystalline plug.
ZOSTAVAX is available in packs of 1 or 10. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon, France
Manufacturer: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN Haarlem, The Netherlands
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
België/Belgique/Belgien: Sanofi Pasteur MSD, Tél/Tel: +32.2.726.95.84
--------: ---- ---- - ---- -------- ---- ---. + 359 2 8193740
-eská republika: Merck Sharp & Dohme, IDEA, Inc.,org. sl.,Tel.: +420.233.010.111 Danmark: Sanofi Pasteur MSD, Tlf: +45.23.32.69.29
Deutschland: Sanofi Pasteur MSD GmbH, Tel: +49.6224.5940
Eesti: Merck Sharp & Dohme OÜ, Tel: +372.613.9750
???-??: ?????? ?.?., ???: +30.210.8009111
España: Sanofi Pasteur MSD S.A., Tel: +34.91.371.78.00
France: Sanofi Pasteur MSD SNC, Tél: +33.4.37.28.40.00
Ireland: Sanofi Pasteur MSD Ltd, Tel: +3531.468.5600
Ísland: Sanofi Pasteur MSD, Sími: +32.2.726.95.84
Italia: Sanofi Pasteur MSD Spa, Tel: +39.06.664.092.11
K-????: Merck Sharp & Dohme Cyprus Limited, ???: +357 22866700
Latvija: SIA Merck Sharp & Dohme Latvija, Tel: +371.67364.224
Lietuva: UAB Merck Sharp & Dohme, Tel.: +370.5.2780.247
Luxembourg/Luxemburg: Sanofi Pasteur MSD, Tél: +32.2.726.95.84
Magyarország: MSD Magyarország Kft, Tel.: + 36.1.888.5300
Malta: Merck Sharp & Dohme Cyprus Limited, Tel: +357 22866700
Nederland: Sanofi Pasteur MSD, Tel: +31.23.567.96.00 Norge: Sanofi Pasteur MSD, Tlf: +47.67.50.50.20 Österreich: Sanofi Pasteur MSD GmbH, Tel: +43.1.866.70.22.202
Polska: MSD Polska Sp. z o.o., Tel.: +48.22.549.51.00
Portugal: Sanofi Pasteur MSD, SA, Tel: +351 21 470 45 50
România: Merck Sharp & Dohme Romania S.R.L. Tel: + 4021 529 29 00
Slovenija: Merck Sharp & Dohme, inovativna zdravila d.o.o., Tel: +386.1.520.4201
Slovenská republika: Merck Sharp & Dohme IDEA, Inc., Tel: +421.2.58282010
Suomi/Finland: Sanofi Pasteur MSD, Puh/Tel: +358.9.565.88.30
Sverige: Sanofi Pasteur MSD, Tel: +46.8.564.888.60
United Kingdom: Sanofi Pasteur MSD Ltd, Tel: +44.1.628.785.291
This leaflet was last approved in:
The following information is intended for medical or healthcare professionals only:
Reconstitution instructions
The solvent is a clear and colourless liquid. Before mixing with the solvent, the powder is a white to off-white compact crystalline plug. When completely reconstituted, the vaccine is a semi-hazy to translucent, off-white to pale yellow liquid.
Withdraw the entire volume of solvent into a syringe. Inject the entire content of the syringe into the vial containing the powder. Gently agitate to dissolve completely. Withdraw the entire content of the reconstituted vaccine vial into a syringe for injection.
It is recommended that the vaccine be administered immediately after reconstitution to minimize loss of potency. Discard if reconstituted vaccine is not used within 30 minutes.
Do not use the reconstituted vaccine if you notice any particulate matter or if the appearance of the solvent or powder or of the reconstituted vaccine differs from that described above.
Any unused product or waste material should be disposed of in accordance with local requirements.
See also section 3. HOW TO USE ZOSTAVAX