Chromatographically purified vero cell rabies vaccine.
Each vial contains protective power of rabies antigen (rabies virus L-Pasteur PV-2061 propagated on vero cell and inactivated by β-propiolactone) ≥2.5 *IU, human serum albumin ≥5 mg , dextran 40 18 mg.
Diluent: Each ampoule contains sterile water for injection 0.5 mL.
*Potency is ≥2.5 IU before and after heating for 4 weeks at 37°C.
The product does not contain a preservative or antibiotic.
The vaccine can induce immunity against rabies virus in recipients following immunization, it is used to protect against rabies.
Pre-exposure vaccination: The person at risk of contacting rabies virus shall be vaccinated following the pre-exposure schedule eg, laboratory personnel handling material contaminated with rabies virus, they should be vaccinated, done the serum test every 6 months, need another booster injection if the antibody titer in the serum is <0.5 IU/mL.
The vaccination is also necessary to the veterinarians and their assistants, animal feeders, gamekeepers, hunters, forestry workers, children in enzootic areas, travelers planning to stay in enzootic areas.
Post-exposure: The person is bitten or scratched by a rabid dog or other rabid animals. The treatment is adapted to the type of wound and status of the animal.
IM Administration: 0.5 mL dose of vaccine shall be injected IM in the deltoid in adults and in the arterio-lateral region of the thigh in young children. Do not inject in the gluteal region.
Intradermal Administration: 0.1 mL dose of vaccine (per site) shall be injected in deltoid.
Pre-exposure Schedule: 3 injections on Day 0, 7 and 28. The injection schedule on Day 28 may be administered on Day 21.
Post-exposure Schedule: Auxiliary Therapy: The treatment of wound is very important and must be performed promptly after the bite. It is recommended firstly to wash the wound with large quantity of water and soap and with detergent and then apply 70% alcohol, tincture of iodine or 0.1% quaternary ammonium solution (provided no soap remains as the 2 products neutralize each other). Curative vaccination must be administered under the medical supervision and only in babies treatment centre.
Vaccination of Non-immunized Subjects: IM schedule (standard IM regimen: ESSEN): 5 injections (0.5 mL) will be given on Day 0, 3, 7, 14 and 28. Intradermal schedule (Modified TRC-ID regimen, 2-2-2-0-2): One dose of vaccine in a volume of 0.1 mL is given intradermally at 2 different sites usually the left and right upper arm on Days 0, 3, 7 and 28.
In the case of type III, anti-rabies immunoglobulin should be administered as well on Day 0. The anti-rabies immunoglobulin (20 IU/kg) of specific human rabies immune globulin or 40 IU/kg of purified rabies serum of equine origin should be used as local wound soakage injection as much as possible with the rest part for muscle injection. The rabies vaccine should be administered in different injection site.
Vaccination of subjects already fully Immunized against Rabies: If vaccine administered in less than 6 months of exposure (cell culture rabies vaccine): Then 1 injection on D0 is recommended.
If vaccine administered in more than 6 months of exposure (cell culture rabies vaccine): Then 2 injections on D0, D3 are recommended.
Reconstitution: To reconstitute the vaccine, introduce the diluent 0.5 mL into the vial of powder and shake thoroughly until the powder is dissolved completely. The solution should be homogenous, clear and free of any particles. Withdraw the solution in a syringe.
Post-exposure Therapy Immunization: Because rabies is a fatal disease, there are no contraindications for immunization including pregnant women.
Pre-exposure Prophylaxis Immunization: The person who is pregnant or in the active period of acute fever is recommended to delay vaccination; the person who has seriously chronic diseases, diseases of the nervous system, seriously hypersensitive diseases or known hypersensitivity to any of the ingredients of the vaccine should avoid use.
IV injection is prohibited.
The vaccine and anti-rabies immunoglobulin must not be administered with the same syringe and in the same injection site.
Before use, please carefully check package, label, appearance and the validity period.
After reconstitution, the freeze-dried rabies vaccine should be administered as soon as possible.
Special Precautions for the Intradermal Route: It is essential that intradermal administration of this vaccine be carried out only by medical staff trained in this technique in order to ensure that the vaccine is delivered intradermally and not subcutaneously.
In the event that a dose of vaccine is inadvertently given SC or IM, a new dose should be administered intradermally immediately.
For the intradermal route a sterile syringe with fixed needle (insulin type) is preferred.
A sterile needle and syringe must be used to withdraw and administer each dose of vaccine for each patient to avoid cross infection. Correct intradermal injection should result in a raised papule with a "peau d'orange" (orange peel) appearance. If the vaccine has been injected too deeply and a papule is not seen, the needle should be withdrawn and re-inserted nearby.
This vaccine does not contain a preservative therefore, great care must be taken to avoid contamination of reconstituted vaccine.
Any reconstituted vaccine should be used as soon as possible. It must be stored in the refrigerator at +2°C and +8°C and used within 8 hrs after reconstitution or discarded.
The intradermal route must not be used in the following instances: Individuals receiving long-term corticosteroid or other immunosuppressive therapy or chloroquine; immunocompromised individuals.
Like other vaccines, the vaccine may cause some adverse reactions in a few individuals: Local reactions: Pain, redness, edema, pruritus and induration at the injection site; the symptoms will be alleviated without treatment after injection. Systemic reaction: Little fever, chill, asphyxia, atony, giddy, arthralgia, muscle pain, gastrointestinal disorder. The serious adverse reactions eg, rare anaphylaxis like tetter, nettle rash should be properly treated under the doctor's instruction.
Besides, any adverse reactions not mentioned in the instruction should be reported timely.
In the case of corticosteroid and immune inhibitor applied, they can affect antibody to be produced, and cause immunization failed. So such patients need to do the antibody neutralization test between 2nd and 4th week after the last vaccination.
Store between +2°C and +8°C. Do not freeze.
J07BG01 - rabies, inactivated, whole virus ; Belongs to the class of rabies viral vaccines.
Vaccine inj (vial/dose) ≥2.5 IU [+ 1 diluent (amp) 0.5 mL + 1 disposable syringe] x 1's, ≥2.5 IU [+ 5 diluent (amp) 0.5 mL] x 5's.
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