Ixiaro

DRUG DESCRIPTION

IXIARO, Japanese Encephalitis Vaccine, Inactivated, Adsorbed is a sterile suspension for intramuscular injection. Each dose of vaccine contains approximately 6 mcg of purified, inactivated JEV proteins and 250 mcg of aluminum hydroxide. The appearance of the liquid is a white, opaque, non-uniform suspension which becomes homogeneous upon shaking. As IXIARO (japanese encephalitis vaccine) is inactivated, it cannot cause Japanese Encephalitis.

IXIARO (japanese encephalitis vaccine) is a vaccine prepared by propagating JEV strain SA14-14-2 in Vero cells. Multiple viral harvests are performed, which are pooled, clarified and concentrated. The virus suspension is treated with protamine sulfate to remove contaminating DNA and proteins. The resulting partially purified virus is processed through a sucrose density gradient centrifugation step and fractionated. Each fraction is analyzed for the presence of virus, and fractions with the highest virus activity are pooled to give a purified virus suspension. The purified virus is then inactivated by treatment with formaldehyde. The preparation is adjusted to a specified protein concentration and formulated by addition of aluminum hydroxide.

The formulated bulk vaccine is filled into syringes, at a volume of 0.5 mL per syringe. From the manufacturing process, IXIARO (japanese encephalitis vaccine) also contains: formaldehyde (not more than 200 ppm), bovine serum albumin (not more than 100 ng/mL), host cell DNA (not more than 200 pg/mL), sodium metabisulphite (not more than 200 ppm), host cell proteins (not more than 300 ng/mL), and protamine sulfate (not more than 1?g/mL). No preservatives, stabilizers, or antibiotics are added to the formulation.



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