Safety Information

Contraindications:

  • Hypersensitivity to this vaccine or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the Product Monograph
  • Do not give the second dose to individuals who show hypersensitivity reactions after the first dose
  • Postpone vaccination with IXIARO® in persons with acute severe febrile conditions

 

Most serious warnings and precautions:

Appropriate medical treatment and supervision should always be available to treat rare cases of anaphylactic reactions following the administration of the vaccine.

  • For intramuscular injection only: UNDER NO CIRCUMSTANCES SHOULD IXIARO® BE ADMINISTERED INTRAVASCULARLY
  • Bleeding disorders: IXIARO® should not be administered to persons with thrombocytopenia, haemophilia or other bleeding disorders

 

Other relevant warnings and precautions:

  • Pregnant Women: Use during pregnancy or lactation should be avoided
  • Nursing Women: IXIARO® should be given to a nursing woman only if the benefit outweighs the theoretical risks to mother and child. It is unknown whether IXIARO® is excreted in human milk.
  • Geriatrics (≥ 65 years of age): Safety and immunogenicity of IXIARO® was evaluated in patients ≥65 years of age. As with many vaccines, the immune response in elderly persons (≥ 65 years of age) to IXIARO® is lower (SCR 65%, GMT 37.4 at Day 70) than in younger adults. Duration of protection is uncertain in older persons, therefore a booster dose should be considered before any further exposure to JE virus. No overall differences in safety were observed in these subjects
  • Immunosuppressed Individuals: In patients receiving immunosuppressive therapy or patients with immunodeficiency an adequate immune response may be diminished

 

For more information:

Please consult the IXIARO® Product Monograph for important information relating to adverse reactions and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling 1-855-356-0831.

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