JEVAX®
JAPANESE ENCEPHALITIS VACCINE

1 ml contains:

Inactivated, purified Japanese Encephalitis virus………………………..   q.s 1 dose

Thimerosal…………………………………………………………………………………………….  ≤ 0.012 %

TCM- 199 w/o red phenol……………………………………………………………….………  q.s 1ml

For prophylaxis of Japanese Encephalitis for adults and children from enough twelve- month old.

1. Do not use in person with hypersensitivity to any component of JEVAX^®
2. Congenital diseases.
3. Tiredness, fever or intensive infectious diseases.
4. Cardiovascular diseases, renal diseases or hepatic diseases.
5. Diabetes or malnutrition.
6. Leukemia and other malignant diseases
7. Anaphylactoid reaction
8. Pregnancy.

• The local adverse effects occur in different level such as: local redness, local swelling ect…
• The systemic adverse effects rarely occur such as: chills, headache, fever ect…

If any of the adverse reactions get serious, or if you notice any adverse reactions not listed in this leaflet, please tell your doctor or pharmatist.

Cautions

• As a injectable vaccine, always must have epinephrine to use for the case of rare anaphylactic shock may occur.

For pregnant women and breast-feeding women

• With womenduringlactation, notanydataonJapaneseencephalitisvaccinefor these womenduring Therefore, ít should consider thebenefits ofthe vaccineindicated.

Warnings

• All preparation and injection must be sterilized. Remove the flip-off (do not open the rubber stopper), sterilized by alcohol-iodine. Syringe and needle must be sterilized and disposable. Shake well before use. The opened vial of vaccine must be used within 6 hours in 2- 8^°C storage condition.
• Person with good immune status repeat 1 dose before a Japanese Encephalitis epidemic.
• In epidemic areas, repeat 1 dose every 3 years to maintain effective immune status.
• Sterilized syringe and needle must be use individually to prevent from HBsAg, HCV, HIV infection….

Administration: Inject subcutaneously.

Dosage

From ≥12 months old to ≤ 36 months old (≤ 3 years old)………………………………..  0.5 ml/dose.

From > 36 months old (3 years old) and adults …………..…………………………………….1.0 ml/dose.

Immunization Schedule:

• Primary immunization:   Initial dose
  • 2^nd dose: one dose after 1^st dose one – two weeks.
  • 3^rd dose: one dose after 1^st dose one year.
• Booster immunization: 01 dose subcutaneous injection every 3 years.

There are not any reports about affecting of JEVAX with other vaccines.

Overdose study is unfeasible. Up to now, no overdose case report has received from user. Further more JEVAX^® is inactivated purified vaccine so it is quite safety. However, as other vaccines, do not overdose.

• Transport and store at from +2ºC to +8ºC.
• Avoid direct sunlight.
• Do not freeze.

The expiry is 24 months from manufacturing date at +2^oC to +8^oC.

• 5 ml (5 doses) /vial x 10 vials/box.
• 1 ml (1 dose) /vial x 10 vials/box.

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