Imojev (SC Injection)
Indications
Therapeutic Class
Pharmacology
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 Encephalitis Vaccine 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.
Dosage & Administration
In children and adolescents up to 18 years of age, if a long term protection is required, one 0.5 mL dose of Encephalitis Vaccine 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 Encephalitis Vaccine can also be given as a booster vaccination in children who were previously given inactivated Japanese encephalitis vaccine for primary vaccination, in accordance with the recommended timing for the booster of the inactivated Japanese encephalitis vaccine.
In adults, there is no need for a booster dose up to 5 years after the administration of a single dose of Encephalitis Vaccine. 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. Encephalitis Vaccine 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.
Contraindications
Encephalitis Vaccine must not be administrated to persons with symptomatic HIV infection or with asymptomatic HIV infection when accompanied by evidence of impaired immune function.
Side Effects
Pregnancy & Lactation
Use 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. Encephalitis Vaccine vaccination is contraindicated in breastfeeding women