IXIARO SUSPENSION FOR INJECTION 0.5ML IN PRE-FILLED SYRINGE [SIN14108P]

Product Info

IXIARO SUSPENSION FOR INJECTION 0.5ML IN PRE-FILLED SYRINGE

[SIN14108P]

4.1 Therapeutic indications

IXIARO is indicated for active immunization against Japanese encephalitis in adults, adolescents, children and infants aged 2 months and older.

IXIARO should be considered for use in individuals at risk of exposure through travel or in the course of their occupation.

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.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information or to the residues protamine sulphate, formaldehyde, bovine serum albumin, host cell DNA, sodium metabisulphite, host cell protein.
Individuals who show hypersensitivity reactions after receiving the first dose of the vaccine should not be given the second dose.
Administration must be postponed in persons with acute severe febrile conditions.