Varicella Vaccine, Live

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Processing Time: 1 Days - 60 Days

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Basic Information

Dosage Form

Injections
Validity

36 months
Strength

0.5 ml /vial
Approval Number

GYZZ S20083005
Place of Origin

Jilin, China (Mainland)

Brief description

Varicella Vaccine, Live

Detailed description

Specifications

1. lyophilized
2. live
3. gelatin-free
4. Oka strain
5. 36 months validity

Drug name

Lyophilized, Live Attenuated Varicella Vaccine

Compositions and form

Compositions:

Lyophilized, live attenuated varicella virus: Oka strain, not less than 2000 PFU, 5 mg-Mannicol, 12.5 mg-Dextran, 25 mg-Sucrose, 10 mg-Trehalose, 5 mg-Albumin, per dose.

A lyophilized preparation (with appropriate stabilizer) of the live attenuated varicella-zoster virus (Oka strain) obtained by propagation of the virus in human diploid cell culture. This product is white fluey pellet in the glass vial. Clear colorless suspension of the vaccine after dissolution

Therapeutic indications

Healthy, varicella-susceptible subjects from the age of 12 months

Effects and purposes

Following vaccination, the body stimulated can generate the immuno-activity against varicella-zoster virus for preventing from varicella.

Specification

0.5 ml vaccine of a single dose for one subject contains at least 2000 PFU of varicella live virus. Complete suspension of lyophilized pellet per vial contains 0.5 ml vaccine.

Immune procedures and dosage

(1) Transfer the diluent into the glass vial of the lyophilized pellet following the instructions. Shake well to ensure complete dissolution of the pellet for use.

(2) Apply 0.5 ml suspension for subcutaneous injection at the deltoid area of the upper arm.

(3) Alcohol and other disinfectors can cause the attenuated virus inactive, thus the vaccine should be applied just after ensuring completely volatilization of the disinfector away from skin.

Undesirable side effects

Very low overall reactogenicity in all the age groups studied.

Reactions at the site of injection are usually mild and temporary.

In a clinical trial involving 600 infants and children, it was observed that papulo-vesicular eruptions appeared in less than 4% of all vaccinees and fever (axillary temperature over 37.5 °C) happened in less than 5% of cases. There is no obvious difference using this product contrasted with the import vaccine.

Contraindications

(1) Contraindicated in subjects with known hypersensitivity to any constituent of this product including neomycin.

(2) Contraindicated in women subjects during pregnancy.

(3) Contraindicated in subjects suffering from serious diseases (acute or chronic infection), fever and any terminal immune disease.

(4) Contraindicated in subjects treated with steroidal drug.

(5) Contraindicated in subjects with a total lymphocyte count of less than 1200 per mm3 or presenting other signs of cellular immunodeficiency.

(6) Contraindicated in subjects with known history of congenital immune disease or having closely touched with the family member who has a history of this disease.

(7) The effects of this product will be cut down for use of whole blood, plasma or immunoglobulin within 5 months before vaccination or within 3 weeks after vaccination.

(8) Avoid the use of salicylate within 6 weeks following vaccination of this product.

Special precautions

(1) It is advisable to have a solution of epinephrine available in the case of anaphylactic reaction.

(2) Generally speaking, it is advisable for the vaccine to be kept under medical supervision for 30 minutes following vaccination of this product.

(3) Transmission of vaccinal virus only occurs in extremely rare cases. All vaccinees who might contract with varicella virus, especially who appear skin reactions after inoculated, should avoid contacting with one who is a pregnant woman (especially less than 3 months pregnancy), or a patient with leucocythemia susceptible with serious varicella virus, or a patient being treated with immunosuppressant.

(4) Administrated hypodermically, not intradermally and never, under any circumstances, intravenously.

(5) Avoid any disinfector to contact the vaccine of this product during opening the vaccine vials and carrying the injection.

(6) Not allow to administrate injection in conditions of incomplete dissolution of this product, cracked glass vial and unclear label of glass vial.

(7) Dissolving with the diluent, the suspension of this product should be used within 30 minutes.

(8) Women of child-bearing age can be vaccinated only if appropriately contraceptive measures have been taken for at least 3 months following vaccination.

(9) Avoid administration of other vaccines within one month following vaccination of this product.

(10) Patients with leucocythemia, tumor or immunodeficiency should be restrainedly used under doctors' guidance.

(11) Attenuated live vaccine not recommended to be used during epidemic seasons.

Storage

Stored in a refrigerator and transported in dark (between 2 °C and 8 °C).

Packaging

The packing material contacting the pellet of this product directly is 2 ml vial made of borosilicate glass.

One vial per dose and one dose per kit accompanied by one vial of sterilized diluent for injection of vaccination.

Validity period

36 months

Production Standard

“Pharmacopoeia of People's Republic of China” Vol. 3, 2010 and the official standard of this product registration

Varicella Vaccine, Live

Company Profile

Established in 2004, our company is located in the High & New Technology Development Zone of Changchun City in Northeast China. Our company is a biopharmaceutical enterprise engaged in the research, development, production and marketing of vaccines, biologics and peptide & chemical drugs.

There are two products of Varicella Vaccines (live) and Human-use Rabies Vaccines (Vero cell) in Chinese market. The sales amount of Varicella Vaccines in 2009 reached RMB220 million and the sales amount of Rabies Vaccines is growing constantly in 2010. A new vaccine being developed in our company against HIV for the prevention of epidemic disease of Aids is in phase II clinical trial in China. Furthermore, a peptide drug for the treatment of diabetes mellitus is on clinical trial and is estimated to be introduced to Chinese market in 2012. In addition, our company has a wide range of projects at different stages in a variety of therapeutic areas and a strong product pipeline, aiming at launching several more vaccines, biologics, peptide and chemical drugs in the coming years.

Since our establishment, our company has been emphasizing building up our cutting-edge technology with the most dedicated and talented scientists and state-of-the-art equipment and facilities. Each year, our company invests a considerable amount of money from the sales turnover in R&D to develop innovative and qualified healthcare products.

About 70 researchers among our 500 staff members are with university education or with postgraduate study in multi-disciplines of chemistry, biology and medicine. Most of them have been working in project R&D and product manufacture in biopharmaceutical industry for many years with adorable experience and expertise. A number of members in the management team and senior consultants have been educated and working in pharmaceutical companies in the USA and Europe. Besides, our company has cooperated with several well-known universities and research institutes in China and in the world to enforce and promote our innovative platform. The long relationship and close dialogues with SFDA (State Food and Drug Administration of China) ensure our products have great development and best fulfill all regulatory requirements in the market.

Changchun BCHT Biotechnology Co. has facilities of laboratories under GLP or GMP management for research, pilot plants for scaling up and factories for product manufacture. The R&D facilities, with an area over 2000sqm and more than 200 sets of instruments, include clear rooms, dark rooms, PCR rooms and laboratories for synthesis, purification, fermentation, analysis, in-vitro tests and animal tests, providing advanced means for our company to develop vaccines and peptide & chemical drugs. The pilot plants, with an area over 3500sqm and more than 300 sets of equipment, allow our company to carry out and promote the promising candidates of products from laboratory to massive production lines in factories. We have three production subsidiaries: BCHT Biopharma for the production of Varicella Vaccines (live), Maifeng Biopharma for the production of Rabies Vaccines and Baiyi Pharma for the production of peptide and chemical drugs in the future, currently under construction and GMP management by FDA for API manufacture.

Noteworthily, Changchun BCHT Biotechnology Co. has an extensive sales network and organization in China for marketing our products.

We sincerely wish to find competitive partners worldwide on technology cooperation and product co-promotion in any possibly creative form, establishing win-win partnerships and achieving bilateral commercial success with customers.

Our mission is as the abbreviation in our company's name - BCHT: "Biotech Creates a Healthy Tomorrow for the mankind".