The product can induce immunity against JE virus in recipients following immunization

Dosage Form      

Freeze-dried

Specifications     

0.5ml of the reconstituted product per container. Each single human dose is 0.5ml containing not less than 5.4 Lg PFU of live JE virus.

Eligible           

Children aged 8 months and above and those who intend to enter the endemic area from non-endemic area.     

Storage & Shipping 

Store and ship at 2-8°C, protected from light.

Validity Period     

18 months starting from the date when titration test proved qualified.

Constituents and characters  

The vaccine is a preparation of live attenuated JE virus (strain SA14-14-2) grown in primary hamster kidney cell monolayer. After harvest a stabilizer is added to virus suspension to prepare freeze-dried vaccine. The product looks like a milky-white crisp cake. After reconstitution, it turns into a transparent orange red liquid.

Contraindications  

The product shall not be administrated to the subjects with fever, acute infectious disease, otitis media, active tuberculosis, cardiac, renal or hepatic diseases, weakness, with a anaphylactic or epilepsy history, with congenital immuno-deficiency, pregnancy, and those who are receiving ongoing or received recently immuno-suppression therapy.

Adverse reactions & Treatment  

Transient fever may occur in a few recipients, which normally does not last longer than 2 days and could be relieved spontaneously. Occasionally, sporadic skin rashes may appear and commonly no particular treatment is needed. In case of necessity, symptomatic treatment might be helpful.

Precautions      

(1)     Avoid the contamination of the vaccine by disinfectant during opening the container and in the course of injection.

(2)     Do not use the vaccine if any leakage of container or clumps not dispersed on shaking are found, or the color of vaccine turned into red before reconstitution.