IMOJEV® POWDER AND DILUENT FOR SUSPENSION FOR INJECTION [SIN14694P]

Product Info

IMOJEV® POWDER AND DILUENT FOR SUSPENSION FOR INJECTION

[SIN14694P]

INDICATIONS

IMOJEV® is indicated for prophylaxis of Japanese encephalitis caused by the Japanese encephalitis virus, in individuals from 9 months of age and over.

DOSAGE AND ADMINISTRATION

Primary Vaccination:

Individuals 9 months of age and over: a 0.5 mL single injection of the reconstituted vaccine.

Booster:

• Adult population (18 years of age and over)

There is no need for a booster dose up to 5 years after the administration of a single dose of IMOJEV®.

• Pediatric population (9 months to 17 years of age inclusive)

A booster dose of IMOJEV® should be given after primary vaccination in order to confer long-term protection. The booster dose should be given preferably 12 months after primary vaccination and can be given up to 24 months after primary vaccination.

IMOJEV® can also be given as a booster vaccination in children who were previously given an inactivated Japanese Encephalitis (JE) vaccine for primary vaccination, in accordance with the recommended timing for the booster of the inactivated JE vaccine.

Safety and efficacy of a booster dose in children and adolescents 5 to 17 years of age have not been established. Nevertheless, the booster dose can be considered based on the available data in other age groups.

Once the freeze-dried vaccine has been completely reconstituted using the diluent provided (see Section “Instructions for use”), it is administered via the subcutaneous route.

In individuals 2 years of age and over, the recommended injection site is the deltoid region of the upper arm.

In individuals between 9 and 24 months of age, the recommended injection site is the anterolateral aspect of the thigh or the deltoid region.

Do not administer by intravascular injection.

IMOJEV® must not be mixed with any other injectable vaccine(s) or medicinal product(s).

Contact with disinfectants is to be avoided since they may inactivate the vaccine virus.

Product is for single use in one patient only. Discard any residue.

Instructions for Use

Using aseptic technique, IMOJEV® vaccine is reconstituted by injecting all the 0.4% sodium chloride solution into the vial of freeze-dried vaccine, using the syringe and one of the needles provided in the carton. The vial is gently swirled. After complete dissolution, a 0.5 mL dose of the reconstituted suspension is withdrawn into this same syringe. For injection, the syringe is fitted with the second needle provided in the package.

The product should be used once reconstituted and must be discarded if it is not used within one hour of reconstitution.

After use, any remaining vaccine and container must be disposed of safely, preferably by heat inactivation or incineration, according to locally agreed procedures.

CONTRAINDICATIONS

IMOJEV® should not be administered to anyone with a history of severe allergic reaction to any component of the vaccine or after previous administration of the vaccine or a vaccine containing the same components or constituents.

Vaccination must be postponed in case of febrile or acute disease.

Congenital or acquired immune deficiency impairing cellular immunity, including immunosuppressive therapies such as chemotherapy, high doses of systemic corticosteroids given for 14 days or more.

IMOJEV® must not be administered to individuals with symptomatic HIV infection or with asymptomatic HIV infection when accompanied by evidence of impaired immune function.

IMOJEV® must not be administered to pregnant women (see Section “Use in Pregnancy” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

IMOJEV® must not be administered to breastfeeding women (see Section “Use in Lactation” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).