Rabies Vaccine (Vero Cell) for Human Use
CAS No : GYZZ S20060076
Place of Origin : Jilin, China (Mainland)
1.first manufacturer using technology of microcarrier bioreactor 2.high potency not less than 2.5 IU
[Constituents and Characters]
The vaccine is liquid preparation of rabies virus grown in Vero Cells. After cultivation, incubation and harvest, the virus suspension is inactivated, concentrated and purified, to which a suitable stabilizer is then added. It is a whitish clear liquid, containing thimerosal as a preservative.
For prophylactic immunisation against rabies. Treatment of patients following suspected rabies contact. If a person is bitten or scratched by a rabid dog or other rabid animal. regardless of age or sex, the wounds shall be cleaned immediately (flush the wounds repeatedly with clean water or soap water, followed by applying iodine tincture or ethanol for several times), and the exposed person shall be inoculated with the vaccine according to the post-exposure schedule as soon as possible. The person at risk contacting rabies virus (such as veterinarians, animal breeders, forestry workers, workers in slaughterhouse and staffs in rabies laboratory) shall be immunized following the pre-exposure treatment schedule.
[Function and Use]
The preparation can induce immunity against rabies virus in immune following immunization. It is used to prevent rabies in human.
1.0 ml per vial. 1.0 ml per single human dose. The potency of the vaccine shall be not less than 2.5 IU.
[Administration and Dosage]
(1) The vaccine shall be shaken homogeneously before use.
(2) The deltoid muscle of the upper arm is the recommended site for I.M. administration. For young children, inoculate the vaccine in the muscle at anterolateral aspect of the thigh.
(3)Post-exposure schedule for immunization: Normally one dose of the vaccine shall be administered to the exposed person on days 0 (the first day), 3 (the fourth day), 7, 14, and 28, consecutively; five doses in total. Children shall be treated in the same way. It is recommended to double the first dose of vaccine in case of one of the following situations:
a. The exposed person was treated with immunoglobulin or antiserum within month before the day of receiving rabies vaccine.
b. Individuals having congenital or acquired immunodeficiency.
c. Those receiving immunosuppressant (including antimalaria drug).
d. The elderly or patients with chronic diseases;Administration of rabies vaccine becomes available to the exposed persons 48 hours or longer after exposure.
Post-exposure treatment shall be dependent on the following classification of wound severity:
Category 1: those petting animal, licked by animal on intact skins without any breaks—neither wound treatment nor administration of vaccine is necessary.
Category 2: those bitten or scratched by animal on skins but without bleeding; or licked on skins with breaks—vaccine shall be administered following the post-exposure immunization schedule.
Category3: those with single or multiple biting wounds on skins with bleeding or scratched with bleeding; mucous membrane was contaminated by saliva of suspected or confirmed rabid animal—the exposed person shall be treated immediately with rabies vaccine, rabies antiserum (40 IU/kg, horse origin) or immunoglobulin (20IU/kg, human origin). If anatomically feasible, infiltration injection of the remaining serum (horse or human origin) shall be performed as much as possible around the wound(s); the rest, if any, shall be injected intramuscularly.
(4) Preexposure immunization schedule: A total of three shots given on days 0,7and 28.
(5) Recommendation of boosters for those immunized with rabies vaccine previously:
Complete post-exposure immunization course was conducted in the recent one year: if bitten by a suspected rabid animal, one dose given on days 0 and 3 separately.
Complete post-exposure immunization course was conducted in the previous year: if bitten by a suspected rabid animal, carry out a complete immunization course again.Complete post-exposure immunization course was conducted in the last 3 years, and followed by boosters: if bitten by a suspected rabid animal, one dose of vaccine shall be given on days 0 and 3 separately.Complete post-exposure immunization course and booster(s) was conducted more than 3 years ago: if bitten by a suspected rabid animal, a complete post-exposure immunization course shall be executed.
After inoculation, mild local or systemic reactions may occur, which could be relieved spontaneously. Occasionally rashes may appear. In case of some serious adverse reactions, such as immediate anaphylactic reactions, angioneurotic edema or urticaria, symptomatic treatment is recommended.
(1) Because rabies is a fatal disease, there are no contraindications for post-exposure immunization.
(2) For preexposure immunization, it is not recommended to immunize eligible individuals with fever, acute disease, serious chronic disease, nervous systematic disease and with a history of allergic reaction to antibiotics and/or biological products. It is recommended to postpone the administration of the vaccine for women in pregnancy and nursing, if feasible.
(1) Do not use the vaccine if the vaccine contains any foreign substance, or any leakage of container or illegible label is found.
(2) Alcoholic drinks, strong tea, pungent food and strenuous exercise shall be avoided after injection of the vaccine.
(3) Do not inject the vaccine in the gluteal region.
Store and ship at 2-8°C, protected from light.
The packing material contacting the pellet of this product directly is 2ml vial made of borosilicate glass.
5 vials/person x 1 person/box
[Standard for Implementation]
Pharmacopoeia of People's Republic of China Vol. 3, 2010 and the official standard of this product registration.
[Product License Number]
SFDA Approval No. GYZZ S20060076
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".