It is indicated for prophylaxis of Japanese encephalitis caused by the Japanese encephalitis virus, in individuals from 12 months of age and over.
Vaccine live attenuated vaccine
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 Encephalitis Vaccine 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.
Primary vaccination: Individuals 12 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 It. ? Paediatric population A booster dose of It 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. It 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 group. 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 12 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. It 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.
It 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 generally for 14 days or more. It must not be administered to individuals with symptomatic HIV infection or with asymptomatic HIV infection when accompanied by evidence of impaired immune function. It must not be administered to pregnant women It must not be administered to breastfeeding women
General disorders and administration site conditions: Influenza like illness, injection site rash, chest discomfort, injection site reaction, injection site induration, oedema peripheral, irritability, injection site haemorrhage, injection site warmth, injection site paraesthesia, asthenia, injection site joint pain, injection site discomfort, tenderness ? Nervous system disorders: Sinus headache, lethargy, paraesthesia, migraine, somnolence, syncope vasovagal, dizziness postural ? Musculoskeletal and connective tissue disorders: Back pain, neck pain, pain in extremity, musculoskeletal pain, pain in jaw, musculoskeletal stiffness, muscle spasms, muscle tightness, intervertebral disc compression ? Gastrointestinal disorders: Abdominal pain upper, dry mouth, lip swelling, dyspepsia, palatal oedema, tongue oedema ? Infections and infestations: Viral infection, urinary tract infection, gastroenteritis, subcutaneous abscess ? Respiratory, thoracic and mediastinal disorders: Sneezing, asthma, pharyngeal erythema, throat irritation ? Skin and subcutaneous tissue disorders: Pruritus, pruritus generalized, rash maculo-papular, rash generalised, swelling face, eczema, urticaria, rash popular, rash macular, rash erythematous ? Investigations: Alanine aminotransferase increased, lymph node palpable ? Injury, poisoning and procedural complications: Sunburn ? Blood and lymphatic system disorders: Lymphadenopathy, leukopenia, lymph node pain, lymphopenia ? Psychiatric disorders: Insomnia ? Ear and labyrinth disorders: Ear pain, tinnitus, vertigo ? Eye disorders: Eye pain, vision blurred, eye pruritus, eye swelling ? Vascular disorders: Flushing, hot flush, hypertension ? Cardiac disorders: Sinus tachycardia ? Immune system disorders: Hypersensitivity ? Metabolism and nutrition disorders: Decreased appetite, increased appetite
Use in Pregnancy (Category B2) Developmental toxicity studies in which female rabbits were SC administered the human dose of it twice prior to mating and three times during gestation, or once between gestation days 6 to 18, or once on postnatal day 15, showed no adverse effects on pregnancy, embryo-fetal development, parturition or postnatal development. Vaccine antigen?specific antibodies were transferred to fetuses. As with all live attenuated vaccines, pregnancy constitutes a contraindication. There is a theoretical risk that a live vaccine virus can cross the placenta and infect the fetus. It is not known whether it can cause fetal harm when administered to a pregnant woman. Women of childbearing age should be advised not to become pregnant for 4 weeks after vaccination. Use in Lactation A developmental toxicity study in which female rabbits were SC administered the human dose of it once between gestation days 6 to 18, or once on postnatal day 15, showed no effects on pup survival, growth and development. It is not known whether this vaccine is excreted in human milk. This vaccination is contraindicated in breastfeeding women Studies with some other live, attenuated virus vaccines have shown that a lactating postpartum woman may secrete the virus in breast milk and infect a breast-fed infant.
Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from light.
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