European Medicines Agency recommends authorisation of two vaccines for influenza pandemic (H1N1) 2009
Q&A from EMEA
Pandemrix (pdf) data sheet includes constituents & adverse side effects
Pandemrix @ Wikipedia
1. NAME OF THE MEDICINAL PRODUCT
Pandemrix suspension and emulsion for emulsion for injection.
Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
After mixing, 1 dose (0.5 ml) contains:
Split influenza virus, inactivated, containing antigen* equivalent to:
3.75 micrograms**
A/California/7/2009 (H1N1)v-like strain (X-179A)
* propagated in eggs
** haemagglutinin
This vaccine complies with the WHO recommendation and EU decision for the pandemic.
AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
The suspension and emulsion, once mixed, form a multidose vaccine in a vial. See section 6.5 for the number of doses per vial.
Excipients: the vaccine contains 5 micrograms thiomersal
For a full list of excipients see section 6.1.
Adjuvant in Pandemrix (pdf) data sheet
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