Ixiaro SA14-14-2

Contact your doctor if you miss a booster dose or if you get behind schedule. The next dose should be given as soon as possible. There is no need to start over.

Be sure to receive all recommended doses of this vaccine. You may not be fully protected if you do not receive the full series.

An overdose of this vaccine is unlikely to occur.

You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.

Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shot caused any side effects.

Becoming infected with Japanese encephalitis is much more dangerous to your health than receiving this vaccine. However, like any medicine, this vaccine can cause side effects but the risk of serious side effects is extremely low.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; dizziness, weakness, fast heart rate; swelling of your face, lips, tongue, or throat.

Common side effects may include:

• headache, tired feeling;

• muscle pain, back pain;

• low fever, chills, flu symptoms;

• cold symptoms such as stuffy nose, sneezing, sore throat, cough;

• mild itching or skin rash;

• nausea, diarrhea; or

• pain, redness, tenderness, or a hard lump where the shot was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report vaccine side effects to the US Department of Health and Human Services at 1-800-822-7967.

The Ixiaro vaccine is given in a series of 2 shots. The shots are usually 28 days apart. Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Ixiaro vaccine is for use in adults and adolescents who are at least 17 years old.

Ixiaro is recommended for people who live in or travel to areas where Japanese encephalitis is known to exist, or where an epidemic has recently occurred.

You should receive the vaccine and booster dose at least 1 week prior to your arrival in an area where you may be exposed to the virus.

Ixiaro is also recommended for people who work in a research laboratory and may be exposed to Japanese encephalitis virus through needle-stick accidents or inhalation of viral droplets in the air.

Becoming infected with Japanese encephalitis is much more dangerous to your health than receiving Ixiaro. However, like any medicine, Ixiaro can cause side effects but the risk of serious side effects is extremely low.

Primary Series: Two 0.5 mL doses, administered intramuscularly 28 days apart
Booster Dose: If the primary series of the two doses was completed more than 1 year previously, a booster dose may be given if ongoing exposure or re-exposure to Japanese encephalitis virus (JEV) is expected

Comments: Complete the primary immunization series at least 1 week prior to potential exposure

Consult WARNINGS section for dosing related precautions.

Administration advice:
-Administer intramuscularly
-Do not administer intravenously, intradermally or subcutaneously
-Preferred sites for IM injection: 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 less than 3 years of age, or the deltoid muscle in individuals 3 years of age and older

Storage requirements: Store in the refrigerator. Do not freeze.

Reconstitution/preparation techniques: Refer to the manufacturer's product information

Caution is recommended Excreted into human milk: Unknown Excreted into animal milk: Data not available The effects in the nursing infant are unknown. The U.S. Centers for Disease Control and Prevention (CDC) consider the administration of vaccines compatible with breast-feeding. However, it should be remembered that neonates are too young to be vaccinated and will not be protected against infection.