Imojev0.5 ml/vial

Imojev 0.5 ml/vial is indicated for active immunisation against Japanese encephalitis in adults, adolescents, children and infants aged 2 months and older. Imojev 0.5 ml/vial should be considered for use in individuals at risk of exposure through travel or in the course of their occupation.

Vaccines, Anti-sera & Immunoglobulin

The vaccine is a live attenuated virus. Following administration, the virus replicates locally and elicits neutralising antibodies and cell-mediated immune responses that are specific to the Japanese encephalitis virus. Available results indicate that protection is mainly mediated by neutralising antibodies.In nonclinical studies, all animals that received a single dose of the vaccine developed specific neutralising antibodies against Japanese encephalitis virus and were protected against infection by a virulent Japanese encephalitis virus experimental challenge.A single dose administration of Imojev 0.5 ml/vial is as immunogenic as a three-dose regimen of an inactivated Japanese encephalitis comparator vaccine administered in adults 18 years of age and over. A seroprotective level of antibodies is generally reached 14 days after vaccination. In persons 9 months of age and over, a seroprotective level of antibodies is generally reached 28 days after vaccination.

Persons 9 months of age and over: one single dose of reconstituted Imojev 0.5 ml/vial 0.5 mL injection should be administered for primary immunization.In children and adolescents up to 18 years of age, if a long term protection is required, one 0.5 mL dose of Imojev 0.5 ml/vial should be given as a booster dose after the first vaccination. The booster dose should be given preferably 1 year after the first vaccination and can be given up to 2 years after the first vaccination.Immunity is maintained at a high level at least 3 years after the booster dose. One 0.5 mL dose of Imojev 0.5 ml/vial can also be given as a booster vaccination in children who were previously given inactivated Japanese Imojev 0.5 ml/vial for primary vaccination, in accordance with the recommended timing for the booster of the inactivated Japanese Imojev 0.5 ml/vial.In adults, there is no need for a booster dose up to 5 years after the administration of a single dose of Imojev 0.5 ml/vial. Once the freeze-dried vaccine has been completely reconstituted using the diluent provided, it is administered via the subcutaneous route. In persons 2 years of age and over, the recommended injection site is the deltoid region of the upper arm.In persons 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 0.5 ml/vial 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.

Adults (18 to ≤ 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: Day 0. Second dose: 28 days after first dose. Rapid schedule: Persons aged 18 to ≤65 years can be vaccinated in a rapid schedule as follows: First dose: 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). It is recommended that vaccinees who received the first dose of Imojev 0.5 ml/vial complete the primary 2-dose vaccination course with Imojev 0.5 ml/vial. 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.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. 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: Day 0. Second dose: 28 days after first dose. Pediatric 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: 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: Day 0. Second dose: 28 days after first dose.

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. Imojev 0.5 ml/vial should never be injected intravascularly. When Imojev 0.5 ml/vial is administered concomitantly with injectable vaccines, they should be given with separate syringes at opposite sites. Exceptionally, Imojev 0.5 ml/vial 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. However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route.

Hypersensitivity to the active substance or to any of the excipients 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.

Very common: headache, muscle pain, injection site pain, injection site tenderness, tiredness.Common: Nausea, influenza like illness, fever, other injection site reactions (e.g. redness, hardening, swelling, itching).Uncommon: vomiting, skin rash, changes in the lymph-nodes, migraine (throbbing headache, often accompanied by nausea and vomiting and sensitivity to light), dizziness, vertigo (spinning sensation), diarrhoea, belly pain, excessive sweating, itching, chills, general condition of feeling unwell, musculoskeletal stiffness, joint pain, weakness, abnormal laboratory liver test results (hepatic enzymes increased).

Use in pregnancy: Animal studies did not indicate direct or indirect harmful effects with respect to pregnancy, embryo-fetal development, parturition or post-natal development. As with all live attenuated vaccines, pregnancy constitutes a contra-indicationUse in lactation: Animal studies did not indicate direct or indirect harmful effects with respect to lactation. It is not known whether this vaccine is excreted in human milk. Imojev 0.5 ml/vial vaccination is contraindicated in breastfeeding women

As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following administration of the vaccine. For patients following a treatment with high doses of systemic corticosteroids given for 14 days or more, it is advisable to wait for at least one month or more following the interruption of therapy before carrying out the vaccination until immune function has recovered. Imojev 0.5 ml/vial should under no circumstances be administered intravascularly.

Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from light.

Vaccines, Anti-sera & Immunoglobulin

The mechanism of action of Japanese encephalitis (JE) vaccines is not well understood. Studies in animals have shown that the vaccine triggers the immune system to produce antibodies against Japanese encephalitis virus that are most often protective. Challenge studies were performed in mice that were treated with human Imojev 0.5 ml/vial antisera. These studies showed that almost all mice that had a Plaque Reduction Neutralization Test titre of at least 1:10 were protected from a lethal Japanese encephalitis virus challenge.

Pregnancy: There are limited amount of data from the use of Imojev 0.5 ml/vial in pregnant women. In animal studies findings of unclear clinical relevance have been identified. As a precautionary measure, the use of Imojev 0.5 ml/vial during pregnancy should be avoided.Breast-feeding: It is unknown whether Imojev 0.5 ml/vial is excreted in human milk. No effects on the breastfed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to Imojev 0.5 ml/vial is negligible. However, in the absence of data and as a precautionary measure the use of Imojev 0.5 ml/vial during lactation should be avoided.Fertility: A study in rats did not indicate vaccine-related effects on female reproduction, foetal weight, survival and development of the off-spring.

Children below 2 months of age: The safety and efficacy of Imojev 0.5 ml/vial in children younger than 2 months has not been established. No data are available.