Vaccinate Varicella Vaccine For Human

[Function and use]

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

[Specifications]

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

[Description]

The vaccine 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 by adding in appropriate stabilizer. it looks like a milky-white crisp cake. after reconstitution it turns into a transparent liquid.

Indications

 Varicella virus vaccine, Live attenuated (oka strain) is indicated for :

 - The active immunization against varicella of healthy subjects from 12 months to 12 years of age

 - The active immunization against varicella of susceptible high-risk patients and their susceptible healthy close contacts in the age group of 12 months to 12 years . Adverse reactions

Common adverse reactions:

 1) Redness, swelling, pain. itching etc. at the site of injection within 24 hours following the injection may be found, which could generally be relieved spontaneously within 2 or 3 days.

 2) Temporal fever reaction may be found within l to 3 weeks after inoculation it is mostly slight (ranging between 37.1 -37.5℃) and can be relieved spontaneously after ane or two days. No specific treatment is necessary. if necessary. rest and increase in fluid intake may prevent secondary infection. For moderate fever (ranging between 37.6-39.0℃) or fever lasting for more than 48 hours, physical treatment or medication can be taken when necessary.

 3) interspersed rash or blebs may appear to few recipients probably within two weeks after injection. No special treatment is necessary.

Symptomatic treatment could be helpful in case of need.

 

Rare adverse reactions:

Serious fever(body temperature above 39℃): Physical treatment or medication is needed to avoid febrile seizures.

 

Very rare adverse reactions:

 1)Allergic skin rash: Urticaria allergic reaction may appear to several individuals within 72 hours after inoculation. and at this time immediate anti-allergic therapy should be given.

 2)Allergic purpura; it may appear to very rare individuals.Timely therapy should be given properly with Cortico-Steroids drug. improper therapy may induce purpura nephritis.

 3)Occasional thrombocytopenic purpura may appear to several recipients.

 

Contraindications

The vaccine should not be used under the following conditions:

  [1] Those who had hypersensitivity history to the vaccine or any component of the formulation

  [2] Those who are pregnant.

  [3] Those who had serious diseases (including acute or chronic infection), at the period of acute attack of chronic disease and fever.

  [4] Those who had immunodeficiency. low immune function or in the period of receiving immunosuppressive therapy.

  [5] Those who had a history of innate immunity defects or contacting with family members who suffer the innate immunity defects.

  [6] Those who had a history of encephalopathy. epilepsy and other nervous system disease.

 

 Precautions

 [1) Use the product with caution in case of: the family or individual with history of convulsions. chronic disease. epilepsy. allergic reaction. or pregnant women.

 [2] Epinephrine or other aid measures should be available at all time to avoid rare allergic reaction after injection of the vaccine.The recipients should be observed for at least 30 minutes

 [3] Care should be taken to avoid contacting the vaccine by disinfectant during the vial opening and injection. The immunization of the vaccine should be done as soon as possible after reconstitution.

 [4] Do not use the vaccine if any leakage of vial. foreign matters on the label. or turbidity of content is found.

 [5] The individuals susceptible to varicella and especially those with skin reaction within 2 or 3 weeks after inoculation should avoid contact pregnant women and the patients of leukemia who are very susceptible to varicella as well as those who are receiving immunosuppressive therapy, and especially avoid the contact with the women in the first three months of pregnancy.

 [6] After the inoculation of the vaccine, women of childbearing age should use contraception for at least three months.

 [7] There should be a one-month interval between the inoculation of other live attenuated vaccines.

 [8] Do not apply the medication of whole blood. plasma or immunoglobulin within 5 months prior to the injection or within three weeks after injection because it will decrease the effect of the product.

 [9] Avoid the use of drugs such as salicylates within 6 weeks after inoculation of the vaccine.

 

Interactions with other medicine

Do not apply the medication of whole blood, plasma or immunoglobulin within 5 months prior to the injection or within three weeks after injection because it will decrease the effect of the product.

Avoid the use of drugs such as salicylates within 6 weeks after inoculation of the vaccine.

There should be a one-month interval between the inoculation of other live attenuated vaccines

 

Pregnancy and lactation

After the inoculation of the vaccine. women of childbearing age should be contracepted for at least three months.

It is not known whether the vaccine is excreted in human milk, because many drugs are excreted in human milk. Cautions should be paid to women in lactation period.

 

Effects of ability to drive and use machines

It is not known whether the vaccine may effect the ability to drive and use machines. cautions should be paid.

 

Antidote for overdosing

Not known.

 

Validity Period

24 months.

 

Shelf life after dilution or reconstitution

It is recommended to use the vaccine as soon as it is reconstituted with SWFI.

 

Shelf life after first opening the container

According to practice use. the vaccine should be used as soon as possible when it is opened.

 

Storage

Stored and transported at 2°C- 8°C. protected from light.

Feature

1. It is recommended in 2 doses (0.5ml each) to ensure optimal protection against varicella with a minimum interval of 6 weeks between doses.

2. For high risk patients additional doses of vaccine may be required.

3. The medium is 2BS human diploid cell. There are 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 ATCC. It is proved that Chickenpox Vaccine is very effective, about 95% of healthy children will induce humour immunity and cell immunity after single dose vaccination. The immunity will keep as long as 20 years after immunization.

1) varicella vaccine                               

2) attenuated varicella-zoster virus         

3) Freeze-dried vaccine                                                   

4) Oka strain                                                                   

5) pre-filled syringe