Lyophilized Hepatitis A Vaccine

[Drug name]  Adopted  name:  Hepatitis  A  ( Live)  Vaccine, Freeze-dried [Description] The freeze-dried hepatitis A vaccine is a preparation made from the live attenuated strain of hepatitis A virus (HAV) grown in human diploid cell cultures. After cultivation, harvest and extraction of the virus, the virus suspension is lyophilized after adding an appropriate srabilizer to make the vaccine.  It looks like a milky-white crisp cake and it turns into a clear liquid after reconstitution. Active constituent: live attenuated Hepatitis A virus. Subsidiary materials: All the components of subsidiary materials approved shall be listed. Diluent:  sterile water for injection. [Eligibles] Hepatitis A - susceptible individuals above one and a half years of age. [Action and use] The product can induce immunity against hepatitis . A virus in recipients following immunization.  It is used to prevent hepatitis A. [Specifications] 0. 5  ml or  l. 0  ml of reconstituted vaccine per container.  0. 5 ml or l. 0 ml per single human dose containing not less than 6.50 lg CCID50 of live hepatitis A virus. [Administration and dosage] Reconstitute the vaccine with sterile water for injection as the stated value.  Shake the container till the content is reconstituted completely before use. Inject s. c. a single human dose of the reconstituted vaccine at deltoid insertion area of the lateral upper arm. [Adverse reactions]