IXIARO Suspension for Injection 0.5ml in pre-filled syringe

INJECTION, SUSPENSION

**4.2 Posology and method of administration** Posology _**Adults**_ (18 – 65 years of age) The primary vaccination series consists of two separate doses of 0.5 ml each, according to the following conventional schedule: First dose at Day 0. Second dose: 28 days after first dose. Rapid schedule: Persons aged 18 – 65 years can be vaccinated in a rapid schedule as follows: First dose at Day 0. Second dose: 7 days after first dose. With both schedules, primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV) (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). It is recommended that vaccinees 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 section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Booster dose A booster dose (third dose) should be given within the second year (i.e. 12 – 24 months) after 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 section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Long-term seroprotection data following a first booster dose administered 12 – 24 months after primary immunization suggest that a second booster should be given 10 years after the first booster dose, prior to potential exposure to JEV. **Elderly** (≥ 65 years of age) The primary vaccination series consists of two separate doses of 0.5 ml each, according to the following conventional schedule: First dose at Day 0. Second dose: 28 days after first dose. The primary immunisation should be completed at least one week prior to potential exposure to Japanese encephalitis virus (JEV) (see section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). It is recommended that vaccinees 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 section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Booster dose As with many vaccines, the immune response in elderly persons to IXIARO is lower than in younger adults. Duration of protection is uncertain in elderly persons, therefore a booster dose (third dose) should be considered before any further exposure to JE virus. Long-term seroprotection following a booster-dose is not known. **Paediatric Population** _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 from 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 section 6.6 for instructions on preparing a 0.25 ml dose for children aged 2 months to < 3 years – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. It is recommended that vaccinees who received the first dose of IXIARO complete the primary 2-dose vaccination course with IXIARO. _Booster dose (Children and adolescents)_ A booster dose (third dose) should be given within the second year (i.e. 12 – 24 months) after primary immunization, prior to potential re-exposure to JEV. Children and adolescents at continuous risk for acquiring Japanese encephalitis (residing in endemic areas) should receive a booster dose at month 12 after primary immunization (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Children and adolescents from 3 years to < 18 years of age should receive a single 0.5 ml booster dose. Children from 14 months to < 3 years of age should receive a single 0.25 ml booster dose. See section 6.6 for instructions on preparing a 0.25 ml dose for children aged 2 months to < 3 years – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. No long-term seroprotection data beyond two years after a first booster administered 1 year after primary immunization has been generated in children. _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. Method of administration The vaccine should be administered by intramuscular 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. When IXIARO is administered concomitantly with injectable vaccines, they should be given with separate syringes at opposite sites. 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 section 4.4 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route.