Source: FDA, National Drug Code (US) Revision Year: 2018
IXIARO, Japanese Encephalitis Vaccine, Inactivated, Adsorbed is a sterile suspension for intramuscular injection. Each 0.5 mL dose of vaccine contains 6 antigen units of purified, inactivated JEV and approximately 250 mcg of aluminum hydroxide. The appearance of the liquid is a white, opaque, non-uniform suspension which becomes homogeneous upon shaking.
IXIARO is a vaccine prepared by propagating JEV strain SA14-14-2 in Vero cells. Multiple viral harvests 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 antigen content 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 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 protein (not more than 100 ng/mL), and protamine sulfate (not more than 1µg/mL). No preservatives, stabilizers, or antibiotics are added to the formulation.
| Dosage Forms and Strengths |
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IXIARO is a suspension for injection supplied in 0.5 mL single dose syringes. For children 2 months to <3 years of age, a single dose is 0.25 mL. For individuals 3 years of age and older, a single dose is 0.5 mL [See Dosage and Administration (2.1)]. |
| How Supplied |
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IXIARO is supplied as a sterile 0.5 mL suspension in a pre filled syringe (Type I glass) with a plunger stopper (chlorobutyl elastomer) in a pack size of 1 single-dose syringe with or without a separate needle. See Section 2.3 for information on preparing a 0.25 mL dose for children 2 months to <3 years of age and a 0.5 mL dose for individuals 3 years of age and older. NDC 42515-002-01. Neither the syringe nor the packaging materials are made with natural rubber latex. |
| Drug | Countries | |
|---|---|---|
| IXIARO | Austria, Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Italy, Lithuania, Netherlands, Poland, Singapore, United Kingdom, United States |
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