INDICATION & USAGE

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

Important Safety Information

Severe allergic reaction after a previous dose of IXIARO, any other Japanese encephalitis vaccine,  or any component of IXIARO, including protamine sulfate a compound known to cause hypersensitivity reactions in some individuals is a contraindication to administration of IXIARO.  Individuals with a history of severe allergic reaction to another Japanese encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered.

Vaccination with IXIARO may not protect all individuals.  Individuals with a weakened immune system may have a diminished immune response to IXIARO.  Fainting may occur when receiving any injection, including IXIARO.  Tell your healthcare practitioner if you have a history of fainting from injections.

The most common (>10%) adverse reactions were: fever, irritability, diarrhea, and injection site redness in infants 2 months to <1 year of age; fever in children 1 to <12 years of age; pain and tenderness in adolescents 12 to <18 years of age; and, headache, muscle pain, and injection site pain and tenderness in adults.

You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.  You should ask your healthcare practitioner for medical advice about adverse events.

For more information, please see the physician’s Prescribing Information and ask your healthcare practitioner about the risk and benefits of IXIARO.

    

INDICATION & USAGE

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

Important Safety Information

Severe allergic reaction after a previous dose of IXIARO, any other Japanese encephalitis vaccine,  or any component of IXIARO, including protamine sulfate  a compound known to cause hypersensitivity reactions in some individuals  is a contraindication to administration of IXIARO.  Individuals with a history of severe allergic reaction to another Japanese encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered.

Vaccination with IXIARO may not protect all individuals.  Individuals with a weakened immune system may have a diminished immune response to IXIARO.  Fainting may occur when receiving any injection, including IXIARO.  Tell your healthcare practitioner if you have a history of fainting from injections.

The most common (>10%) adverse reactions were: fever, irritability, diarrhea, and injection site redness in infants 2 months to <1 year of age; fever in children 1 to <12 years of age; pain and tenderness in adolescents 12 to <18 years of age; and, headache, muscle pain, and injection site pain and tenderness in adults.

You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.  You should ask your healthcare practitioner for medical advice about adverse events.

For more information, please see the physician’s Prescribing Information and ask your healthcare practitioner about the risk and benefits of IXIARO.

    

 

 

References

  1. World Health Organization. Fact sheets. Japanese encephalitis. Published December 2015. http://www.who.int/mediacentre/factsheets/fs386/en. Accessed March 27, 2018.
  2. Centers for Disease Control and Prevention. Viral hemorrhagic fevers (VHFs). Flaviviridae. Updated April 2014. https://www.cdc.gov/vhf/virus-families/flaviviridae.html. Accessed March 27, 2018.
  3. Centers for Disease Control and Prevention. Japanese encephalitis. Updated August 2015. https://www.cdc.gov/japaneseencephalitis/. Accessed March 27, 2018.
  4. Centers for Disease Control and Prevention. Yellow Book 2018, Chapter 3. Updated May 2017. https://wwwnc.cdc.gov/travel/yellowbook/2018/infectious-diseases-related-to-travel/japanese-encephalitis. Accessed March 27, 2018.
  5. Cheng V, Sridhar S, Wong S, et al. Japanese encephalitis virus transmitted via blood transfusion, Hong Kong, China. Emerg Infect Dis. 2018;24(1):49-57.
  6. Hills SL, Griggs AC, Fischer M. Japanese encephalitis in travelers from non-endemic countries, 1973- 2008. Am J Trop Med Hyg. 2010;82(5):930-936.
  7. Heffelfinger JD, Li X, Batmunkh N. et al. Japanese encephalitis surveillance and immunization – Asia and Western Pacific regions, 2016. Morb Mortal Wkly Rep. 2017;66(22):579-583.
  8. Centers for Disease Control and Prevention. Japanese encephalitis. Prevention. Updated August 2015 https://www.cdc.gov/japaneseencephalitis/prevention/. Accessed March 27, 2018.
  9. Centers for Disease Control and Prevention. Japanese encephalitis. Vaccine. Updated August 2015 https://www.cdc.gov/japaneseencephalitis/vaccine/index.html. Accessed March 27, 2018.
  10. Connor BA, Bunn WB. The changing risk of Japanese encephalitis for business travelers. Workplace Health Saf. 2015;63(12):568.
  11. Buhl MR, Lindquist L. Japanese encephalitis in traveling: review of cases and seasonal risk. J Travel Med. 2009;16(3): 217-219.
  12. IXIARO [prescribing information]. Vienna, Austria; Valneva Austria GmbH; 2018.

Indication & Usage

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

Important Safety Information

Severe allergic reaction after a previous dose of IXIARO, any other Japanese encephalitis vaccine,  or any component of IXIARO,  including protamine sulfate a compound known to cause hypersensitivity reactions in some individuals is a contraindication to administration of IXIARO.  Individuals with a history of severe allergic reaction to another Japanese encephalitis vaccine may be referred to an allergist for evaluation if immunization with IXIARO is considered.

Vaccination with IXIARO may not protect all individuals.  Individuals with a weakened immune system may have a diminished immune response to IXIARO.  Fainting may occur when receiving any injection, including IXIARO.  Tell your healthcare practitioner if you have a history of fainting from injections.

The most common (>10%) adverse reactions were: fever, irritability, diarrhea, and injection site redness in infants 2 months to <1 year of age; fever in children 1 to <12 years of age; pain and tenderness in adolescents 12 to <18 years of age; and, headache, muscle pain, and injection site pain and tenderness in adults.

You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit www.vaers.hhs.gov or call 1-800-822-7967.  You should ask your healthcare practitioner for medical advice about adverse events.

For more information, please see the physician’s Prescribing Information and ask your healthcare practitioner about the risk and benefits of IXIARO.

 

 

 

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