Dengvaxia

Dengvaxia

Manufacturer:

Kalventis Sinergi Farma
Concise Prescribing Info
Contents
Dengue tetravalent vaccine (live, attenuated)
Indications/Uses
Reduce risk of the event & severity of dengue disease caused by dengue virus serotype 1, 2, 3 & 4 in individuals 9-16 yr living in endemic areas who have previously been infected w/ dengue virus (seropositive).
Dosage/Direction for Use
SC Primary vaccination 3 inj of 0.5 mL at 6-mth interval.
Contraindications
Hypersensitivity to the vaccine or after previous inj. Postpone vaccination in individual suffering from moderate to severe febrile or acute disease. Congenital or acquired immune deficiency that impairs cell-mediated immunity including immunosuppressive therapies (eg, chemotherapy or high doses of systemic corticosteroids generally given ≥2 wk). Symptomatic or asymptomatic HIV infection when accompanied by evidence of impaired immune function. Not to be administered to pregnant or breastfeeding women.
Special Precautions
Not to be inj intravascularly. May not protect all vaccinees; continue personal protection measures against mosquito bites after vaccination. Increased risk of hospitalization for dengue & clinically severe dengue in individuals not previously infected by dengue virus. Not recommended for individuals who have not been previously infected by dengue virus; w/o prior dengue infection, living in non-endemic areas, who travel to endemic areas. Wait until immune function has recovered in patients receiving high doses of systemic corticosteroids given for ≥2 wk. History of serious or severe reactions w/in 48 hr after a prior administration. Syncope; phenylketonuria. Women of childbearing potential should avoid becoming pregnant for 4 wk after vaccination. Not to be administered in individuals <9 yr.
Adverse Reactions
Headache; myalgia; inj site pain, malaise, asthenia, fever. Inj site reactions eg, erythema, swelling.
Drug Interactions
Not to be mixed w/ any other injectable vaccines or medications. Delay administration for 6 wk to 3 mth after treatment w/ Ig eg, blood or plasma to avoid neutralization of attenuated virus in the vaccine.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07BX - Other viral vaccines ; Used for active immunizations.
Presentation/Packing
Form
Dengvaxia powd for inj
Packing/Price
((vial) + 2.5 mL (vial) solvent ) 5 dose x 5 × 1's; (1 dose (vial) + 0.5 mL (pre-filled syringe) solvent) 1's
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