Section 2 Qualitative and quantitative composition
Section 2: Qualitative and quantitative composition 1 dose (0.5 ml) contains: Hepatitis B surface antigen 1, 2, 3 20 micrograms 1 adjuvanted by AS04C containing: - 3-O-desacyl-4’- monophosphoryl lipid A (MPL) 2 50 micrograms 2 adsorbed on aluminium phosphate (0.5 milligrams Al3+ in total) 3
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