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Japanese Encephalitis Virus Vaccine Inactivated
- Patient Information:
Details with Side Effects
JE-VAX®, Japanese Encephalitis Virus Vaccine Inactivated, is a sterile, lyophilized vaccine for subcutaneous use, prepared by inoculating mice intracerebrally with Japanese encephalitis (JE) virus, "Nakayama-NIH" strain, manufactured by The Research Foundation for Microbial Diseases of Osaka University ("BIKEN ® buffered saline, pH 8.0. The homogenate is centrifuged and the supernatant inactivated with formaldehyde, then processed to yield a partially purified, inactivated virus suspension. This is further purified by ultra-centrifugation through 40% w/v sucrose. The suspension is then lyophilized in final containers and sealed under dry nitrogen atmosphere. Thimerosal (mercury derivative) is added as a preservative to a final concentration of 0.007%. The diluent, Sterile Water for Injection, contains no preservative. Each 1.0 mL dose contains approximately 500 µg of gelatin, less than 100 µg of formaldehyde, less than 0.0007% v/v Polysorbate 80, and less than 50 ng of mouse serum protein. No myelin basic protein can be detected at the detection threshold of the assay ( < 2 ng/mL). Prior to reconstitution, the vaccine is a white caked powder, and after reconstitution the vaccine is a colorless transparent liquid. The potency of JE vaccine is determined by immunizing mice with either the test vaccine or the JE reference vaccine. Neutralizing antibodies are measured in a plaque neutralization assay performed on sera from the immunized mice. The potency of the test vaccine must be no less than that of the reference vaccine.
What are the possible side effects of this vaccine (Je-Vax)?
You should not receive a booster vaccine if you had a life-threatening allergic reaction after the first shot.
Keep track of any and all side effects you have after receiving this vaccine. When you receive a booster dose, you will need to tell the doctor if the previous shots caused any side effects.
Becoming infected with Japanese encephalitis is much more dangerous to your health than receiving the vaccine to protect against it. Like any medicine, this vaccine can cause side effects, but the risk of serious side effects is extremely low.
Get emergency medical help if you...
Last reviewed on RxList: 11/4/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Je-Vax Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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