Je-Vax

DRUG DESCRIPTION

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...

Read All Potential Side Effects and See Pictures of Je-Vax »


Je-Vax Patient Information Including Side Effects

Brand Names: Je-Vax

Generic Name: Japanese encephalitis virus vaccine (Nakayama) (Pronunciation: JAP a NEEZ en CEF a LYE tis NA ka YA ma)

  • What is Japanese encephalitis virus vaccine (Nakayama) (Je-Vax)?
  • What are the possible side effects of this vaccine (Je-Vax)?
  • What is the most important information I should know about this vaccine (Je-Vax)?
  • What should I discuss with my healthcare provider before receiving this vaccine (Je-Vax)?
  • How is this vaccine given (Je-Vax)?
  • What happens if I miss a dose (Je-Vax)?
  • What happens if I overdose (Je-Vax)?
  • What should I avoid before or after receiving this vaccine (Je-Vax)?
  • What other drugs will affect Japanese encephalitis virus vaccine (Nakayama) (Je-Vax)?
  • Where can I get more information?

What is Japanese encephalitis virus vaccine (Nakayama) (Je-Vax)?

Japanese encephalitis is a serious disease caused by a virus. It is the leading cause of viral encephalitis (inflammation of the brain) in Asia. Encephalitis is an infection of the membrane around the brain and spinal cord. This infection often causes only mild symptoms, but prolonged swelling of the brain can cause permanent brain damage or death.

Japanese encephalitis virus is carried and spread by mosquitos.

The Japanese encephalitis Nakayama vaccine is used to help prevent this disease in adults and children who are at least 12 months old.

This vaccine works by exposing you to a small dose of the virus, which causes the body to develop immunity to the disease. This vaccine will not treat an active infection that has already developed in the body.

This vaccine is recommended for people who plan to spend 30 days or longer in areas where Japanese encephalitis is known to exist, or where an epidemic has recently occurred. The vaccine should also be given to people who will spend any amount of time in rural areas where Japanese encephalitis is endemic, or those who are otherwise at high risk of coming into contact with the virus.

You should receive this vaccine and all booster shots at least 10 days prior to your arrival in an area where you may be exposed to the virus.

Not everyone who travels to Asia needs to receive a Japanese encephalitis vaccine. Follow your doctor instructions or the recommendations of the Centers for Disease Control and Prevention (CDC).

This vaccine is also recommended for people who work in a research laboratory and may be exposed to Japanese encephalitis virus through needle-stick accidents or inhalation of viral droplets in the air.

Like any vaccine, the Japanese encephalitis Nakayama vaccine may not provide protection from disease in every person.

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 have any of these signs of an allergic reaction (which may occur up to 17 days after you receive the shot): hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • feeling light-headed, fainting;
  • high fever;
  • behavior changes; or
  • seizures (black-out or convulsions).

Less serious side include:

  • redness, pain, or swelling where the shot was given;
  • low fever, chills, flu symptoms;
  • headache, tired feeling;
  • muscle pain;
  • nausea, vomiting, stomach pain; or
  • mild itching or skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about this vaccine (Je-Vax)?

The Japanese encephalitis Nakayama vaccine is given in a series of 3 shots. The booster shots are usually given 7 days and 2 weeks to 1 month after the first shot. Your individual booster schedule may be different from these guidelines. Follow your doctor's instructions or the schedule recommended by the health department of the state you live in.

Japanese encephalitis Nakayama vaccine is for use in adults and children who are at least 12 months old.

This vaccine is recommended for people who plan to spend 30 days or longer in areas where Japanese encephalitis is known to exist, or where an epidemic has recently occurred. The vaccine should also be given to people who will spend any amount of time in rural areas where Japanese encephalitis is endemic, or those who are otherwise at high risk of coming into contact with the virus.

You should receive the vaccine and all booster doses at least 10 days prior to your arrival in an area where you may be exposed to the virus.

Not everyone who travels to Asia needs to receive a Japanese encephalitis vaccine. Follow your doctor instructions or the recommendations of the Centers for Disease Control and Prevention (CDC).

This vaccine is also recommended for people who work in a research laboratory and may be exposed to Japanese encephalitis virus through needle-stick accidents or inhalation of viral droplets in the air.

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.

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