Varicella Vaccine, Live(vial)

Product Description

[Compositions and Form]
The vaccine is made by propagation of attenuated varicella-zoster virus (Oka strain) in human diploid cell culture (MRC*5), after cultivation and harvest, the virus suspension is lyophilized to make the vaccine after addition of a suitable stabilizer. This product is white fluey pellet in the glass vial. The reconstituted vaccine after dissolution with diluent is a clear solution without visually detectable presence of foreign particles.
Active ingredient: Live varicella-zoster virus(Oka strain): not less than 3.3 lgPFU (***0 PFU)
Inactive ingredients: Trehalose, Human Albumin, Sodium Glutamate, Sucrose, Glucose, Urea,
Arginine.
Diluent: Sterile Water for Injection
[Therapeutic indications]
The vaccine is indicated for the active immunization against varicella of healthy, varicella-susceptible subjects from age of *2 months.
[Specification]
The vial contains 0.5 ml liquid by dissolution of the lyophilized vaccine with the diluent. The reconstituted vaccine contains not less than 3.3 lg PFU of live varicella-zoster virus and is used for one subject in a single dose.
[Immune procedures and dosage]
(1) One dose of basic immunization for children of ***2 years old; two doses of basic immunization for people of *3 years old and above with **8 weeks of interval.
(2) Transfer the diluent with a syringe into the vial containing lyophilized vaccine. Shake well to ensure complete dissolution of the pellet for use and transfer all the liquid back to the syringe.
(3) Apply 0.5 ml suspension for subcutaneous injection at the deltoid area of the upper arm.
According to the epidemic data and clinical research literatures at home and abroad, the Health Authorities in the provincial level or above can make one-dose booster immunization for people below *2 years old based on the local epidemic surveillance if necessary.