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Ixiaro

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Ixiaro

Indications
Dosage
How Supplied

INDICATIONS

IXIARO is a vaccine indicated for the prevention of disease caused by Japanese encephalitis virus (JEV). IXIARO is approved for use in individuals 2 months of age and older.

DOSAGE AND ADMINISTRATION

For intramuscular administration only.

Dosage And Schedule

Primary Series

Children 2 months to < 3 years of age: Primary immunization with IXIARO consists of two (2) 0.25 mL doses, administered 28 days apart.

Individuals 3 years of age and older: Primary immunization with IXIARO consists of two (2) 0.5 mL doses, administered 28 days apart.

Complete the primary immunization series at least 1 week prior to potential exposure to JEV.

Booster Dose

Individuals 17 years of age and older: If the primary series of two doses was completed more than 1 year previously, a booster dose may be given if ongoing exposure or re-exposure to JEV is expected.

Infants, children and adolescents 2 months to < 17 years of age: The safety and immunogenicity of a booster dose has not been evaluated.

Administration

IXIARO is administered intramuscularly. The preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 2 to 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle if muscle mass is adequate) in children 1 to < 3 years of age, or the deltoid muscle in individuals 3 years of age and older.

Do not administer intravenously, intradermally, or subcutaneously.

Preparation For Administration

Prior to agitation, IXIARO is a clear liquid with a white precipitate. Before administration, shake the syringe well to obtain a white, opaque, homogeneous suspension.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. If either of these conditions exists, do not administer.

Preparation of a 0.25 mL Dose of IXIARO for Administration to Children 2 Months to < 3 Years of Age:

  1. Shake the pre-filled syringe containing 0.5 mL to obtain a homogeneous suspension.
  2. Remove the syringe tip cap by gently twisting it. Do not attempt to snap or pull the tip off as this may damage the syringe.
  3. Attach a sterile safety needle to the pre-filled syringe (needle is not provided with IXIARO).
  4. Hold the syringe in an upright position and uncap the needle.
  5. Push the plunger stopper up to the edge of the red line on the syringe barrel, indicated by a red arrow (see Figure 1)*, and discard expelled volume into a medical waste container.INTERCELL AG IXIARO
  6. Lock the needle safety shield and remove the needle.
  7. Attach a new sterile needle prior to injection of the remaining volume.

*If the plunger stopper is pushed beyond the red line, do not administer the vaccine. Repeat the procedure using a new pre-filled syringe.

Figure 1: Preparation for Administration of 0.25 mL Dose

Push the plunger stopper up to the edge of the red line - Illustration

Preparation of a 0.5 mL Dose of IXIARO for Administration to Individuals 3 Years of Age and Above:

  1. Shake the pre-filled syringe containing 0.5 mL to obtain a homogeneous suspension.
  2. Remove the syringe tip cap by gently twisting it. Do not attempt to snap or pull the tip off as this may damage the syringe.
  3. Attach a sterile needle to the pre-filled syringe (needle is not provided with IXIARO).

HOW SUPPLIED

Dosage Forms And Strengths

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]

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 42515-001-01.

Neither the syringe nor the packaging materials are made with natural rubber latex.

Storage And Handling

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.

License Holder: Intercell AG, Vienna, Austria. Manufacturer: Intercell Biomedical Ltd., Livingston, UK and Distributed by: Novartis Vaccines and Diagnostics, Inc., 350 Massachusetts Avenue, Cambridge, Massachusetts 02139. Issued May 2013

Last reviewed on RxList: 9/11/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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