Drug name]
Common name: Rabies Vaccine for Human Use (Vero cell)
English name: Rabies Vaccine for Human Use (Vero cell)
Chinese Pinyin: Renyong Kuangquanbing Yimiao (Vero Xibao)
Common name: Freeze-dried rabies vaccine for human use (Vero cells)
English name: Rabies Vaccine for Human Use ( Vero cell), Freeze-dried
Chinese Pinyin: Donggan Renyong Kuangquanbing Yimiao (Vero Xibao)
[Ingredients and Characteristics]
This strain uses rabies virus (L Pasteur fixed virus PV2061 strain) After inoculation with Vero cell culture, the virus liquid is harvested, concentrated, inactivated, purified, and added with an appropriate amount of human albumin. 1 Immune dose means that the protective titer is equal to or higher than 2.5 international units (IU) during the validity period. This product is an adjuvant-free vaccine and is a colorless, clear liquid.
This strain is inoculated with rabies virus (L Pasteur fixed virus PV2061 strain) and cultured in Vero cells. The virus liquid is harvested, concentrated, inactivated and purified, and an appropriate amount of human albumin is added. , made from dextran. 1 Immune dose means that the protective titer is equal to or higher than 2.5 international units (IU) during the validity period. This product is a white loose body and becomes a clear liquid after being dissolved with diluent. The diluent is a colorless, clear solution.
[Targets to be vaccinated]
Before exposure:
This vaccine is used to prevent rabies. It is recommended that the following people be vaccinated according to the pre-exposure vaccination program:
All workers exposed to persistent risks: such as rabies virus diagnosis and research workers, should be immunized; it is recommended to conduct serological testing every 6 months. When the serum antibody titer is lower than the recognized protection level (0.5 IU/ml), a booster shot should be given.
Any person who is at risk of exposure to rabies virus: such as veterinarians, animal breeders, forestry workers, slaughterhouse workers, cave dwellers, children, adults and tourists in animal colonies should be vaccinated .
After exposure:
Anyone who is bitten or scratched by an animal with or suspected of having rabies should be vaccinated immediately according to the post-exposure procedure.
[Action and use]
After vaccination, this vaccine can stimulate the body to produce immunity against rabies virus and be used to prevent rabies.
[Specifications]
Water injection: Each box contains 5 vaccines, 0.5ml/tube, 1 dose/tube.
Freeze-drying: Each box contains 5 freeze-dried vaccines and 5 0.5ml diluents. 1 dose/tube.
[Immunization schedule and dose]
This vaccine is for intramuscular injection into the deltoid muscle of the upper arm, and for young children, it can be injected intramuscularly into the anterolateral area of ??the thigh. Buttock injections are prohibited.
Pre-exposure immunization program: Basic immunization: 3 doses on days 0, 7, and 28. A booster dose will be given after 1 year. Thereafter, one dose of booster vaccination will be given every 5 years.
Post-exposure immunization program:
1. Adjuvant Treatment Local wound treatment must be performed immediately after the bite. It is recommended to first wash the wound repeatedly with soap or detergent and plenty of water, and then wash it with 75% alcohol or iodine tincture. Treatment must be carried out under the supervision of a doctor. 2. For those who have not received immunization, full vaccination: 1 dose of vaccine on days 0, 3, 7, 14, and 28, for a maximum of 5 doses. The dosage for children is the same. In the case of Category III exposure (see table below), anti-rabies immune globulin must be applied simultaneously with this vaccine at different sites).
One human anti-anti-rabies immune globulin: 20 international units/kg body weight
One horse anti-anti-rabies immune globulin: 40 international units/kg body weight
In rabies-endemic areas, it is recommended to receive 2 doses of vaccine on day 0 for those with severe bites or those with an area close to the central nervous system, those who seek treatment late, or those with immune deficiencies.
Recommended treatment after exposure:
Wound injury type, degree of exposure, recommended treatment
Level I exposure: touching or feeding animals, being inflicted wounds by animals, if there is a reliable medical history ,
No treatment required
Level II exposure: skin bites and scratches without bleeding; if the broken skin is licked, get vaccinated immediately
Level III exposure: single Or multiple bites or abrasions that penetrate the skin; mucous membranes are contaminated with saliva (such as licking wounds); the bite site is close to the central nervous system and anti-rabies immune globulin is injected immediately and vaccines
Note: Treatment can be discontinued when the offending animal remains healthy during the 10-day observation period, or when confirmed to be rabies negative by appropriate laboratory testing techniques.
3. For those who have received immunization: those who have received a booster shot to prevent immune diseases within 5 years, receive 2 shots, one dose each on days 0 and 3. Those who have received preventive immunization within 5 years but not boosted or those who last boosted immunization more than 5 years ago will be vaccinated with 5 injections, one dose each on days 0, 3, 7, 14 and 28. If necessary, rabies immune globulin is required. For people whose immune status is uncertain, 5 doses should be administered.
[Adverse reactions]
This vaccine may produce varying degrees of adverse reactions in individual recipients.
——Local reactions: pain, erythema, edema, itching, and induration at the injection site.
——Systemic reactions: mild fever, chills, syncope, weakness, headache, dizziness, joint pain, myalgia, gastrointestinal dysfunction.
——In addition, rare allergic reactions, rashes, and urticaria may also occur. Report any adverse reactions not specified in this manual promptly.
[Contraindications]
1. Post-exposure therapeutic vaccination. Since rabies is a fatal disease, post-exposure therapeutic vaccination has no contraindications.
2. Pre-exposure vaccination
-Severe allergic diseases.
-It is recommended to postpone vaccination during the active stages of fever, acute illness, and chronic disease.
-Persons who are known to be allergic to any vaccine component.
[Precautions]
Water injection:
1. This product cannot be injected intravascularly, and it is prohibited to insert the needle into the blood vessel.
2. Anti-rabies immune globulin and this vaccine must not be injected in the same syringe or at the same site. 3. Before use, please check whether the packaging container, label, appearance, and expiration date meet the requirements.
Freeze-drying:
1. This product cannot be injected intravascularly, and it is prohibited to insert the needle into the blood vessel.
2. Dissolve the vaccine in diluent and use it immediately.
3. Anti-rabies immune globulin and this vaccine must not be injected in the same syringe or at the same site. 4. Before use, pay attention to check whether the packaging container, label, appearance, and expiration date meet the requirements.
[Storage] Store and transport in the dark at 2-8℃.