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Varicella Vaccine (live), Freeze-dried 返回>>

Direction for Use of Varicella Vaccine (live), Freeze-dried

 

    Varicela is a highly contagious disease caused by the initial infection with varicella zoster virus. It is an airborne disease and may be spread from one to two

days before the rash appears until all lesions have crusted over. Complications may occasionally include pneumonia, inflammation of the bratin , or bacterial infections of the skin among others. Children are easily infected, especially in school and kindergarten. Routine immunization of children is recommended in many countries.

    In 2008 Changchun Changsheng Life Sciences Ltd. has successfully developed Varicella Vaccine and it has been approved by China Food and Administration. The medium of Varicella Vaccine is 2BS human diploid cell. There is  complete cell bank to produce other vaccine such as Hepatitis A Vaccine which is suitable for large-scaled production. The seed virus is Oka strain from ATTC. It is proved that Varicella Vaccine is very effective, about 95% of healthy children will induce humoral immunity and cell immunity after single dose vaccination. The immunity will keep as long as 20 years after immunization.

scaled production. 

 

[Drug name]

Adopted name: Varicella Vaccine (live), Freeze-dried

[Constituents]

The freeze-dried Varicella Vaccine (live) is a preparation of the Varicella virus strain of Oka grown in human diploid cell cultures. After cultivation and harvest, the virus suspension is lyophilized to make the vaccine.

[Characters]

It looks like a milky-white crisp cake; after reconstitution it turns into a milky-white clear liquid.

[Specifications]

0.5ml of reconstituted vaccine per container. 0.5ml per single human dose containing not less than 3.4Lg PFU Oka virus.

[Function and use]

The product can induce immunity against varicella-zoster virus in recipients following immunization. It is used to prevent varicella.

[Eligibles]

Varicella susceptible individuals at the age between 1 year old to 12 years old.

[Administration and dosage]

Reconstitute the vaccine with the stated amount of sterile water for injection and shake the container till the content is reconstituted completely before use. Inject 0.5ml s.c. the reconstituted vaccine at deltoid insertion area of the lateral upper arm where disinfected with 75 percent alcohol.

[Contraindications]

[1] The immunization of whom with serious diseases or fever should be deferred.

[2] Prohibition to use for those with a history of allergy and pregnant women.

[3] It is forbidden for those has immunodeficiency or low immune function or those who is receiving immunosuppression treatment.

[Adverse reactions] 

Generally, no adverse reactions after injection. Occasionally minor local reaction appear, such as erythema, swelling, ache, itch, etc within 24 hours after injection. Rarely mild or moderate fever may appear , they could generally be relieved spontaneously within 3 days. Symptomatic treatment could be helpful in case of need.

[ Precautions ]

[1] Care should be taken to avoid contacting the vaccine by disinfectant during opening the container and in the course of injection. The immunization of Varicella Vaccine (live), Freeze-dried should be done as soon as possible after reconstitution.

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

[3] S.C is recommended, intradermal injection can not be used, and intravenous injection is forbidden.

[4] The immunization of Varicella Vaccine (live), Freeze-dried should be deferred for at least one month or 5 months in advance of administration of immunoglobulin.

[5] Those patients with high-risk such as leukemia cancer and patients with immune deficiencies should use the vaccine cautiously with guidance of doctors.
[6] After the inoculation of Varicella Vaccine (live), Freeze-dried, women of childbearing age should be contraceptated for at least three months.

[7] It belongs to the attenuated live vaccine, thus it is not recommended to inoculate during the popular season of such disease. There should be a one-month interval between the inoculation of other vaccines.

[ Storage and Validity period]

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

Use before the expiry date indicating in the box (or vial)

[ Packaging]

It includes a vial of varicella vaccine and an ampoul of water for injection. One human dose per box.

[ Validity period]

18 months.


 

 
 
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