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Prevention of dengue disease caused by any dengue virus serotype in individuals ≥4 yr.

SC Preferably, inj in upper arm in deltoid region. Individual ≥4 yr at time of 1st inj 0.5 mL at 2-dose (0 & 3 mth) schedule.

Hypersensitivity. Individuals w/ congenital or acquired immune deficiency including immunosuppressive therapies eg, chemotherapy or high doses of systemic corticosteroids (eg, 20 mg/day or 2 mg/kg/day of prednisone for ≥2 wk) w/in 4 wk prior to vaccination; symptomatic or asymptomatic HIV infection accompanied by evidence of impaired immune function. Pregnancy & lactation.

Anaphylaxis (appropriate medical treatment & supervision should always be readily available in the event of rare anaphylactic reaction following administration). Not to be inj intravascularly, intradermally or IM. Postpone vaccination in subjects suffering from acute severe febrile illness. Anxiety-related reactions including vasovagal reactions (syncope), hyperventilation or stress-related reactions as psychogenic response to needle inj. Patients w/ chronic medical conditions. Review medical history prior to vaccination especially w/ regard to previous vaccination & possible hypersensitivity reactions after vaccination. Continue personal protection measures against mosquito bites after vaccination. Seek medical care if dengue symptoms or warning signs develop. Patients receiving Ig or blood products containing Ig eg, blood or plasma should wait for at least 6 wk, & preferably for 3 mth, following end of treatment before administration. Not to be mixed in same syringe w/ any other vaccines or parenteral medicinal products. Administer vaccine at different inj sites if to be given at the same time w/ other vaccines. May temporarily have minor influence on ability to drive & use machines. Renal & hepatic impairment. Women of childbearing potential should avoid pregnancy for at least 1 mth following vaccination. Women who intend to become pregnant should delay vaccination. Childn <4 yr.

URTI; decreased appetite; irritability; headache, somnolence; myalgia; inj site pain & erythema, malaise, asthenia, fever. Nasopharyngitis, pharyngotonsillitis; arthralgia; inj site swelling, bruising & pruritus, flu-like illness.

Concomitant use w/ Ig or blood products containing Ig eg, blood or plasma; immunosuppressive therapies eg, chemotherapy or high doses of systemic corticosteroids.

Vaccines, Antisera & Immunologicals

J07BX04 - dengue virus vaccines ; Belongs to the class of other viral vaccines. Used for active immunization against Dengue virus.

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