Ixiaro

Ixiaro Dosage/Direction for Use

vaccine, japanese encephalitis

Manufacturer:

Valneva

Distributor:

Pharmaforte
Full Prescribing Info
Dosage/Direction for Use
Adults: The primary vaccination series consists of two separate doses of 0.5 ml each, according to the following schedule: First dose at Day 0.
Second Dose: 28 days after the first dose.
It is recommended that vacinees who received the first dose of IXIARO complete the primary 2-dose vaccination course with IXIARO.
If the primary immunization of two injections is not completed, full protection against the disease might not be achieved. There is data that a second injection given up to 11 months after the first dose results in high seroconversion rates (see Pharmacology: Pharmacodynamics under Actions).
Booster Dose (Adults): A booster dose (third dose) should be given within the second year (ie, 12-24 months) after the recommended primary immunization, prior to potential re-exposure to JEV. Persons at continuous risk for acquiring Japanese encephalitis (laboratory personnel or persons residing in endemic areas) should receive a booster dose at month 12 after primary immunization (see Pharmacology: Pharmacodynamics under Actions). Data on the need for further booster doses are not available.
Children and adolescents from 3 years to <18 years of age: The primary vaccination series consists of two separate doses of 0.5 ml according to the following schedule: First dose at Day 0.
Second Dose: 28 days after first dose.
Children 2 months to <3 years of age: The primary vaccination series consists of two separate doses of 0.25 mL according to the following schedule: First dose at Day 0.
Second dose: 28 days after first dose. See Cautions for Usage.
It is recommended that vaccinees who received the first dose of IXIARO complete the primary 2-dose vaccination course with IXIARO.
Children below 2 months of age: The safety and efficacy of IXIARO in children younger than 2 months has not been established. No data are available.
Booster Dose (children and adolescents): Data on the timing of and response to a booster dose children and adolescents (<18 years of age) are not available.
Method of Administration: The vaccine should be administered by intamuscular injection into the deltoid muscle. In infants, the anterolateral aspect of the thigh may be used as injection site. IXIARO should never be injected intravascularly.
Exceptionally, IXIARO can also be administered subcutaneously to patients with thrombocytopenia or bleeding disorders since bleeding may occur following an intramuscular administration. Subcutaneous administration could lead to a suboptimal response to the vaccine (see Precautions). However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route.
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