What M-M-RVAXPRO contains
The active substances are:
After reconstitution, one dose (0.5 ml) contains:
Measles virus1 Enders Edmonston strainlive, attenuated.not less than 1x103 CCID50 Mumps virus1 Jeryl Lynn Level B strainlive, attenuatednot less than 12.5x103 CCID50 Rubella virus2 Wistar RA 273 strain live, attenuated .not less than 1x103 CCID50
* 50% cell culture infectious dose
12 produced in chick embryo cells. produced in WI-38 human diploid lung fibroblasts.
The other ingredients are:
Powder:
sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin, medium 199 with Hanks? salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid (to adjust pH), and sodium hydroxide (to adjust pH)
Solvent:
water for injections
What M-M-RVAXPRO 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 mixed with solvent provided.
The solvent is a clear and colourless liquid. The powder is a light yellow compact crystalline cake.
M-M-RVAXPRO is available in packs of 1 and 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 Responsible for Batch Release: 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, +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 (Middle East) 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 (Middle East) 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:
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The following information is intended for medical or healthcare professionals only:
Reconstitution instructions
The solvent is a clear colourless liquid. Before mixing with the solvent, the powder is a light yellow compact crystalline cake. When completely reconstituted, the vaccine is a clear 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 the same syringe and inject the entire volume.
If two needles are provided: use one needle to reconstitute the vaccine and the other for its administration to the person to be vaccinated.
It is recommended that the vaccine be administered immediately after reconstitution or stored in the refrigerator and used within 8 hours to minimize loss of potency. Discard if reconstituted vaccine is not used within 8 hours.
Do not freeze the reconstituted vaccine.
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 M-M-RVAXPRO.