產品資訊 - Ready to Fill Bulk of Rabies Vaccine->aspalthic products

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Changchun Changsheng Life Sciences Ltd.

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Ready to Fill Bulk of Rabies Vaccine

產品分類 :

化學->化學用品->aspalthic products

產品規格

Model No:	L

Country	CN
Payment Term	L/C,T/T

產品描述

Rabies Vaccine (Vero Cell) for Human Use, Freeze-dried


[Description]


The vaccine is a freeze-dried preparation made from the inactivated rabies fixed virus.  The virus grows in Vero  cell cultures.  After cultivation and harvest, the virus suspension is concentrated,


inactivated, purified, and lyophilized to make the vaccine after the addition of a suitable stabilizer.


The product looks like a white crisp cake. After reconstitution, it shall turn into a transparent liquid without containing any preservatives.


Active constituent :  Inactivated rabies fixed virus. Subsidiary materials: All of the subsidiary materials approved shall be listed.


Diluent: Sterile water for injection


[Eligibles]


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 soap water


and then apply iodine tincture or ethanol repeatedly to the wounds. ), and the exposed person shall be inoculated with the vaccine according to the postexposure schedule as soon as possible. The


persons 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 immunization schedule.


[Action and use]


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


[Specifications]


0.5 ml or 1.0 ml of reconstituted vaccine per container.0.5 ml or 1.0 ml per single human does. The potency of the rabies vaccine shall be not less than 2.5 IU.


[Administration and dosage]


Reconstitute the freeze-dried vaccine with the enclosed sterile water for injection as the stated value, and shake the container thoroughly before use.


(2) Inject i. m. the vaccine at deltoid insertion area of the upper arm.


For young children, inoculate the vaccine in the muscle at anteroexternal aspect of the thigh.


(3) Postexposure immunization schedule:


Normally one dose of the vaccine shall be administered to the exposed person on days 0 (the first day i. e. that very day), 3 (the fourth day, analogically  henceforth ), 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 conditions :


①The individuals with chronic diseases were injected with rabies immunoglobulin or rabies antiserum one day or earlier before the day of receiving rabies vaccine.


② Those with congenital or acquired immunodeficiency.


③ Those receiving immunosuppressive therapy (including  antimalaria  drug) .


④The elderly.


⑤ Administration of rabies vaccine becomes available to the exposed persons 48 hours or longer


 after exposure.


 Postexposure treatment shall be dependent on the following classification of wound severity :


Category I: Those petting animal, licked by animal on intact skins without  any breaks -Neither


wound treatment nor administration of vaccine is necessary.


Category II : Those bitten or scratched by animal on skins but without bleeding - The vaccine shall


be  administered following  the  postexposure immunization schedule.


Category III : Those with single or multiple biting wounds on skins with bleeding or scratched with bleeding or mucous membrane contaminated by the 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 rabies immunoglobulin ( 20 IU/kg, human origin). If anatomically feasible,


infiltration injections 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. The rabies antiserum or rabies immunoglobulin is only for single use.


(4) Pre-exposure immunization schedule:A total of three shots shall be given on days 0, 7 and 21 0r 28.


(5) Recommendation of boosters for those immunized with rabies vaccine  previously :


① Complete postexposure immunization schedule was conducted within the recent one year: If bitten by a suspected rabid animal, one does given on days 0 and 3,separately.


②Complete postexposure immunization schedule was conducted before one year: If bitten by a


suspected rabid animal, carry out complete immunization schedule again.


③Complete postexposure immunization schedule was conducted within the last 3 years, and followed by boosters: One dose of vaccine shall be given on days o and 3, separately, if bitten by a


suspected rabid animal.


④Complete postexposure immunization schedule and booster (s) were conducted more than three years ago: A complete postexposure immunization schedule shall be executed if bitten by a suspected rabid animal.


[Adverse reactions]


Common adverse reactions :


(l) Redness, swelling, pain, itch may occur at the injection site within 24 hours after vaccination, which can be relieved spontaneously without treatment.


(2) Systemic reactions may include low fever, malaise, headache, dizziness, arthralgia, myalgia, vomiting, and bellyache, which can be relieved spontaneously and need no particular treatment.


Rare adverse reactions :


The recipients with transient moderate or severe fever shall receive physical therapy or symptomatic treatment to prevent febrile convulsions.


Extremely rare adverse reactions :


(1) Allergic rash: Urticaria may occur generally within 72 hours after vaccination  The recipients with urticaria shall receive anti-anaphylactic treatment promptly.


(2) Anaphylactic shock: Anaphylactic shock may occur within one hour after vaccination. The recipients with anaphylactic shock shall receive emergency treatment immediately including prompt injection of adrenaline.


(3) Allergic purpura: The recipients with allergic purpura shall go to the clinic promptly and receive anti-anaphylactic treatment with corticosteroid in time. If the treatment is inappropriate or delayed, purpuric nephritis may be complicated.


(4) Those who afflict with angioneurotic edema or nervous system reactions after vaccination, shall receive the medical treatment in time.


[Contraindications]


Because rabies is a fatal disease, there is no contraindications for postexposure immunization.


Pre-exposure immunization :


(l) Subjects with known allergic reactions to any component of the vaccine, including subsidiary


materials and antibiotics.


(2) Subjects with acute diseases, severe chronic diseases, and chronic diseases at acute attack stage


and fever.


(3) Subjects with uncontrolled epilepsy or other progressive diseases of nervous system.


[Precautions]


(l) The vaccine shall be administered with caution to the subjects with family or individual history of convulsion or those with chronic diseases, history of epilepsy, allergic diathesis or to the nursing women.


(2) Do not use the vaccine if the container shows abnormalities, such as crack, illegible label,


exceeding expiry date, and turbidity after reconstitution.


(3) The vaccine shall be administered immediately after it is reconstituted completely.


(4) Adrenaline should be available for first aid in case of severe anaphylactic reactions. The recipients shall be observed for at least 30 minutes on site following injection.


(5) Alcoholic drinks, strong tea. pungent food and strenuous exercise shall be avoided after


injection of the vaccine.


(6) Injection of the vaccine in the gluteal region is prohibited. Do not inject the vaccine intravascularly.


(7) Rabies immunoglobulin or rabies antiserum shall not be used with the same syringe used for the injection of the vaccine9 and the two preparations shall not be given in the ipsilateral limb.


(8) The principle of postexposure immunization shall be observed, i. e. timely. immunization, and immunization on the entire schedule with enough doses. The allergic individuals shall go to the clinic and receive antianaphylactic treatment to complete the entire schedule of immunization.


(9) Treatment with corticosteroid or immunosuppressive therapy can interfere with the induction of antibody and cause the failure of immunization.


(10) Freezing is strictly forbidden.




 


1.Vero cell                                                                      


2.inactivated rabies fixed virus                      


3.bit or scratch by rabid dog   

 
 

 


 
 



 
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