IXIARO (japanese encephalitis vaccine) is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus (JEV) in persons 17 years of age and older.

Immunization Series

Immunization with IXIARO (japanese encephalitis vaccine) consists of 2 doses administered 28 days apart. Immunization series should be completed at least 1 week prior to potential exposure to JEV.

Administration

Before administration, shake the syringe well to obtain a white, opaque, homogeneous suspension. Do not administer if particulate matter remains following shaking or if discoloration is observed.

Each 0.5 mL dose of IXIARO (japanese encephalitis vaccine) is administered intramuscularly into the deltoid muscle. Do not administer intravenously, intradermally, or subcutaneously.

Dosage Forms And Strengths

IXIARO (japanese encephalitis vaccine) is a suspension for injection supplied in 0.5 mL single dose syringes. [See DESCRIPTION]

Storage And Handling

IXIARO (japanese encephalitis vaccine) 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 syringe with or without a separate needle. NDC 42515-001-01.

None of the syringe or packaging materials contain latex.

Storage Conditions

Store in a refrigerator at 2° to 8° C (35° to 46° F). Do not freeze.

Do not use the vaccine after the expiration date shown on the label. Store in the original package in order to protect from light. During storage, a clear liquid with a white precipitate can be observed.

Handling

Prior to agitation, IXIARO (japanese encephalitis vaccine) may appear as a clear liquid with a white precipitate. After thorough agitation, it forms a white, cloudy liquid/suspension. The vaccine should be visually inspected for coarse particulate matter and discoloration prior to administration. Discard the product if particulates are present or if it appears discolored or if the syringe appears to be physically damaged.

Any unused product or waste material should be disposed of in accordance with local requirements.

Issued January 2009. Manufactured by: Intercell Biomedical, Oakbank Park Road, EH51 0TG, Livingston, UK. T: +44.1506.446.600. F: +44.1506.446.601. www.intercell.com. Distributed by: Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue Cambridge, Massachusetts 02139, US.

Last reviewed on RxList: 3/11/2010
This monograph has been modified to include the generic and brand name in many instances.