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]

(1) Pain and tenderness may occur at the injection site generally within 24 hours after vaccination, which can be relieved spontaneously within 2-3 days in most cases.

(2)  Transient fever may occur generally within l-2 weeks after vaccination, most of which are mild . and can be relieved spontaneously within l-2 days and need no particular treatment. If necessary, the recipients should have an appropriate rest and drink more hot water. Care should be taken to keep warm for the prevention of secondary infections. The recipients with moderate fever or with the fever lasting for more than 48 hours may receive physical therapy or symptomatic treatment.

(3) Occasionally, sporadic rash may occur after vaccination and commonly no particular treatment is needed. In case of necessity, symptomatic treatment might be helpful.

Rare adverse reactions :

Severe fever: Physical therapy and symptomatic treatment shall be adopted to prevent febrile convulsion.

Extremely rare adverse reactions :

(l) Anaphylactic shock: Anaphylactic shock may occur within one hour after vaccination, emergency measures shall be adopted immediately including prompt injection of adrenaline.

(2) Allergic rash: Urticaria may occur generally within 72 hours after vaccination, if it occurs the recipients shall go to the clinic promptly and receive anti-anaphylactic treatment.

(3) Allergic purpura: The recipients with allergic purpura shall go to the clinic promptly and receive anti-anaphylactic treatment with corticosteroid. If the treatment is inappropriate or delayed,  purpuric nephritis may be complicated.

[Function and use]

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

[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 stabilizer 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.

[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.

[Feature]

 Advantages:   1.Accordance with the trend of biomedicine.

               2. Convenient for storage and transportation.

               3. The improvement of the stability of the vaccine,30-months of self life.

               4. The extension of the validation.

               5. More stable immune results

Results from the study group of National 95 Key Task Project:

 100% safety for injection of live hepatitis A vaccine,freeze-dried

 100% seroconversion rate after 2 dose injection

 100% epidemiologic protective efficacy

lAll of the products passed the national quality control