產品資訊 - Clinical Rabies Vaccine For Human Use->aspalthic products

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Changchun Changsheng Life Sciences Ltd.

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Clinical Rabies Vaccine For Human Use

產品分類 :

化學->化學用品->aspalthic products

產品規格

Model No:	0.5ml /syringe

Country	CN
Minimum Order	5000
Payment Term	L/C,T/T

產品描述

Rabies vaccine is a freeze-dried preparation made from the inactivated rabies fixed virus. The virus grows in Vero cells. After cultivation, harvest and concentration, the virus suspension is inactivated, purified and then lyophilized to make the vaccine after the addition of a suitable stabilizer.  It is used to prevent rabies.

 



If a person is bitten or scratched by a rabid dog or other rabid animals, regardless of age or sex, the wounds shall be cleaned immediately (flush the wounds repeatedly with clean water or soup 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 of 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 recipients following immunization. It is used to prevent rabies in human.


 


[Specifications]


0.5 ml of reconstituted vaccine per container. 0.5 ml per single human dose. The potency of the vaccine shall be not less than 2.5 IU.


 



[Diluent of Vaccine]


Sterile water for injection used as the diluent shall comply with the specifications set forth in Volume II of the Chinese Pharmacopoeia.


[Control tests on final product]


Other than the determination of the moisture content,the enclosed sterile water for injection shall be added into the final product as the stated value,and the reconstitude product shall be subjected to the following tests.


  Identity test


Rabies viral antigen in the tese sample shall be demonstrated with ELISA.


 Apperance


The product looks like a white crisp cake.After reconstitution,it shall turn into transparent liquid free from foreign matters.


 Chemical tests


   pH


The pH shall be 7. 2-8. 0 (Appendix V A).


  Moisture content


The content of residual moisture shall be not more than 3. 0% (Appendix XII D).


 Potency test


The potency of the vaccine shall be not less than 2. 5 IU/dose (Appendix XI A).


  Thermostability test


Before release each lot of vaccine shall be subjected to thermostability test.  The test sample is exposed at 37℃for 28 days for the determination of potency (Section 3. 4. 4) .  The test vaccine which passed the thermostability test is considered satisfactory in potency test.


 Test for residual bovine serum albumin


The content of residual bovine serum albumin shall be not more than 50 µg/does (Appendix XIII I).


 Test for the content of residual antibiotics


Test for the content of residual antibiotics shall be carried out if antibiotics have been added during the production. The residual antibiotic content shall be not more than 50 ng/dose determined by ELISA.


 Test for residual DNA of Vero cells


The residual DNA of Vero cells shall be not more than 100 pg/dose (Appendix IX B, method l).


 Test for residual protein of Vero cells


The residual protein of Vero cells shall be not more than 4 µg/dose by ELISA.


  Sterility test


It complies with the test for sterility (Appendix XII A) .


  Test for abnormal


It complies with the test (Appendix XII F).


 Test for bacterial endotoxin


The content of bacterial endotoxin shall be not more than 50EU/does.(Appendix XII E, gel-clot limit test).



[Feature]


 1. High potency at least 4.0IU/dose


 2. Perfect stability, 3-years shelf life


 3. Fine purification above 99%.


 4. No serious adverse reaction.


 5. Medium can be controlled effectively.


<img src="http://i.bosscdn.com/product/e6/40/1a/52042c3373d7e6bc01c1975301.png@watermark=2&color=I0ZGRkZGRg%3D%3D&type=ZHJvaWRzYW5zZmFsbGJhY2s%3D&size=22&p=5&t=80&text=Y3MtdmFjY2luZS5ib3NzZ29vLmNvbQ%3D%3D" title="rabies" alt="rabies" />


 
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