Concise Prescribing Info
Contents
Live, attenuated, recombinant Japanese encephalitis virus (propagated in Vero cells) 4-5.8 log PFU
Indications/Uses
Prophylaxis of Japanese encephalitis caused by Japanese encephalitis virus in patients ≥9 mth.
Dosage/Direction for Use
SC Primary vaccination Patient ≥9 mth 0.5 mL single inj. Booster Childn up to 18 yr 0.5 mL dose 12-24 mth after primary vaccination. Childn previously given an inactivated Japanese encephalitis vaccine for primary vaccination 0.5 mL as booster dose in accordance w/ the recommended timing for the booster of the inactivated Japanese encephalitis vaccine. Patient ≥2 yr Inj in the deltoid region of the upper arm. Patient 9-24 mth Inj in the anterolateral aspect of the thigh or the deltoid region.
Contraindications
Hypersensitivity to the vaccine or after previous inj. Postpone vaccination in case of febrile or acute disease. Congenital or acquired immune deficiency impairing cellular immunity including immunosuppressive therapies eg, chemotherapy & high doses of systemic corticosteroids given for ≥14 days. Symptomatic or asymptomatic HIV-infected patient w/ evidence of impaired immune function. Pregnancy & lactation.
Special Precautions
Do not administer intravascularly. Treatment w/ high doses of systemic corticosteroids given for ≥14 days should wait at least ≥1 mth before vaccination. Not to be mixed w/ any other inj vaccine(s) or medicinal product(s).
Adverse Reactions
Malaise, inj site pain; headache; myalgia. Inj site swelling; erythema; vomiting. Adult: Fatigue. Feeling hot, chills, pruritus, inj site bruising; dizziness; arthralgia; diarrhoea, nausea, abdominal pain; pharyngolaryngeal pain, dyspnea, rhinorrhoea, cough, wheezing, nasal congestion; rash. Childn: Pyrexia, irritability; somnolence; loss of appetite; crying.
Drug Interactions
Separate inj sites & syringe when other vaccines are concomitantly administered. Concomitant use w/ immunosuppressive or corticosteroid therapy. Vaccination must not be performed w/in 6 wk & not w/in 3 mth of Ig inj or blood products containing Ig eg, blood or plasma.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BA03 - encephalitis, Japanese, live attenuated ; Belongs to the class of encephalitis viral vaccines.
Presentation/Packing
Form
Imojev vaccine (inj)
Packing/Price
(vial) 0.5 mL x 10 × 1's (Rp406,153/boks); (vial) 0.5 mL x 1's
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