(lyophilization, gelatin-free) Varicella Vaccine, Live - Exportimes.com

Supplier Details

Changchun BCHT Biotechnology Co.  

Year Established:2004

Business Type:Business Service

Management Certifiation: GMP

Operational Address:

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(lyophilization, gelatin-free) Varicella Vaccine, Live

(lyophilization, gelatin-free) Varicella Vaccine, Live
  • (lyophilization, gelatin-free) Varicella Vaccine, Live
  • (lyophilization, gelatin-free) Varicella Vaccine, Live
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(lyophilization, gelatin-free) Varicella Vaccine, Live

Product Details

Parameter

Dosage Form : Injections
Validity : 36 months
Strength : 0.5 ml/vial
Approval Number : GYZZ S20083005
Place of Origin : Jilin, China (Mainland)

Description

Specifications

1. varicella Oka strain recommanded by WHO
2. lyophilized, live
3. gelatin-free, MRC-5, stablizer with patent

Compositions and dosage form

  Single dose vial with varicella Oka strain virus not less than 3.3 lg plaque-forming units [PFU] per 0.5 mL dose when reconstituted to a suspension contains manicole 5 mg, dextran 12.5 mg, sucrose 25 mg, trehalose 10 mg, human albumin 5 mg.

  This whity, fuzzy, lyophilized preparation constituted with a particular stabilizer, containing with live, attenuated varicella-zoster virus (Oka strain) proliferated in human diploid cell (MRC-5), to be reconstituted with sterile diluent gives a semi-hazy to translucent, off-white to pale yellow liquid with no corpus alienum.

 

Indications

  Varicella Vaccine, Live is a live attenuated virus vaccine indicated in individuals susceptible in varicella and not less than 12 months for prevention from varicella.

 

Function and use

  Following vaccination, the vaccinee body stimulated can generate the immune response against varicella virus for prevention from varicella.

  

Specifications

  Reconstituted with 0.5 mL diluent for one vaccinee, a vial of single 0.5mL dose of vaccine contains not less than 3.3 lg PFU of live varicella virus.

 

Administration and dosage

  Preparation for Administration

  Withdraw the entire contents of the diluent into a syringe. To avoid excessive foaming, slowly inject all of the diluent in the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly.

  Administered as a single 0.5 mL dose subcutaneously in the deltoid region of the upper arm.

Alcohol or other antiseptics may inactivate the attenuated vaccine virus. Administrate just after complete volatilization of the antiseptics away from skin.

  Recommended dosage

  Reconstituted with 0.5 ml diluent for one vaccinee, a vial of single 0.5mL dose of vaccine contains not less than 3.3 lg PFU of live varicella virus.

 

Adverse reactions

  Very low Systematic adverse reactions in all the age groups studied.

  Adverse reactions on the injection site are usually mild and temporary.

  In a clinical trial involving 600 infants and children, it was observed that among all vaccines, sporadic papulo-vesicular eruptions appeared in less than 4% incidence and fever (axillary temperature over 37.5 °C) happened in less than 5% cases.  This product has no significant difference from the import vaccine.

 

Contraindications

  Do not administer this vaccine to individuals with a history of anaphylactic reaction to neomycin or any other component of the vaccine.

  Should not be administered to pregnant females.

  Should not be administered to individuals treated with steroidal medicine.

  Do not indicate in individuals suffering from serious diseases (acute or chronic infection), fever and any terminal immune disease.

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

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

  Do not administer this vaccine to individuals with a total lymphocyte count less than 1200 per mm3 or having other manifestations of cell immunodeficiency.

  The suspension of this product following reconstitution with the diluent should be used within 30 minutes.

  Women of child-bearing age should take appropriate conception control at least 3 months following vaccination.

  Avoid administration with other vaccines within one month following vaccination.

Patients with leucocythemia, tumor or immunodeficiency should be restrainedly used under doctors’ guidance.

  Attenuated live vaccine should be not recommended for use during epidemic seasons.

  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 following vaccination.

 

Storage

  Stored in a refrigerator and transported at 2-8°C against light. 

 

Packaging

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

1vial/person x 1 person/box.

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

 

Standard for implementation

  Chinese Pharmacopoeia” Vol. 3, 2010 and the official standards for registration of this product.

 

Product license number

  SFDA approval No.GYZZ S20083005 

 

 Warnings and precautions

  For the vaccinee to be kept under medical supervision for 30 minutes following administration with this product.

  As with any vaccine, adequate treatment provisions, including epinephrine injection (1:1000), should be available for immediate use should an anaphylactic reaction occur.

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

  Administrate this vaccine subcutaneously.  Do not inject intravascularly or intramuscularly.

  Do not allow to administrate the vaccine under conditions of incomplete reconstitution of this product, vaccine vial cracking and unclear labeling.

  Avoid alcohol or other antiseptics to contact the vaccine of this product during administration.

(lyophilization, gelatin-free) 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".

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