Hepatitis A (Live) vaccine, freeze-dried

The freeze-dried hepatitis A vaccine is a preparation of the live attenuated strain of hepatitis A virus (HAV)

Direction for Use of Hepatitis A (Live) Vaccine, Freeze-dried

[ Drug name ]

Adopted name : Hepatitis A (Live) Vaccine, Freeze-dried

[ Constituents and characters ]

The freeze-dried hepatitis A vaccine is a preparation of the live attenuated strain of hepatitis A virus (HAV) grown in human diploid cell cultures. After cultivation and harvest, the virus suspension is purified, and lyophilized after adding an appropriate stabilizer to make the vaccine. It looks like a milky-white crisp cake; after reconstitution it turns into a clear liquid.

[ Eligibles ]

Hepatitis A susceptible individuals above the age of 18 months.

[ Function and use ]

The product can induce immunity against hepatitis A virus in recipients following immunization. It is used to prevent hepatitis A.

[ Specifications ]

1.0 ml of reconstituted vaccine per container. 1.0 ml per single human dose containing not less than 6.50lg CCID50 of live hepatitis A virus.

[ Administration and dosage ]

Reconstitute the vaccine with the stated amount of sterile water for injection site. Shake the container till the content is reconstituted completely before use. Inject 1.0ml s.c. the reconstituted vaccine at deltoid insertion area of the lateral upper arm.

[ Adverse reactions ]

A few recipients might have pain, erythema and swelling at the injection site, which could generally at the injection site, which could generally be relieved spontaneously within 3 days. Occasionally skin rash may appear and no special treatment is necessary. Symptomatic treatment could be helpful in case of need.

[ Contraindications ]

Subjects with discomfort, body temperature (subaxillary) over 37.5°C.

Those with acute infectious disease or other serious diseases.

Those with immunodeficiency or receiving immunosuppressant.

Those with a history of allergy.

[ Precautions ]

Care should be taken to avoid contacting the vaccine by disinfectant during opening the container and in the course of injection.

Do not use the vaccine if any leakage of container, foreign matters, or turbidity of content is found.

The immunization of hepatitis A vaccine should be deferred for at least one month following administration of immunoglobulin.

Use the vaccine cautiously for pregnant women.

[ Storage and shipping ]

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

[ Validity period ]

24 months.

Hepatitis A (Live) vaccine, freeze-dried