Finished Products of Rabies Vaccine (Vero Cell) for Human Use [Drug Name] Adopted name: Rabies Vaccine (Vero Cell) for Human Use[Description] The vaccine is a liquid preparation made from the inactivated rabies fixed virus (aGV). The virus grows in Vero cells cultured on microcarriers. After cultivation and harvest, the virus suspension is concentrated, inactivated by β-propiolactone, and purified by column chromatography before the addition of a suitable stabilizer to make the vaccine. It is a slightly milky-white, transparent liquid and can contain thimerosal as a preservative. [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] 1.0 ml per vial. 1.0 ml per single human dose each time. The potency of the rabies vaccine shall be not less than 2.5 IU. [Administration and dosage] (1) The deltoid muscle of the upper arm is the recommended site for intramuscular i.m. administration. For young children, inoculate the vaccine in the muscle at anteroexternal aspect of the thigh.(2) Postexposure immunization schedule:Normally one dose of the vaccine shall be administered to the exposed person on day 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 the vaccine in case of one of the following conditions:① The individuals were injected with rabies immunoglobulin or rabies antiserum one month before the day of receiving rabies vaccine.② Those with congenital or acquired immunodeficiency.③ Those receiving immunosuppressive therapy (including antimalaria drug).④ The elderly or patients with chronic diseases.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; or licked on skins with breaks-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 and rabies antiserum (40 IU/kg) or rabies immunoglobulin (20 IU/kg) according to the postexposure schedule. If anatomically feasible, infiltration injections of the remaining rabies antiserum or immunoglobulin shall be performed as much as possible around the wound(s); the rest, if any, shall be injected intramuscularly.(3) Pre-exposure immunization schedule: A total of three shots given on day 0, 7 and 28.(4) Recommendation of boosters for those immunized with rabies vaccine previously:① Complete postexposure immunization schedule was conducted within the recent one year: One dose shall be given on day 0 and 3, separately, if bitten by a suspected rabid animal.② Complete postexposure immunization schedule was conducted before one year: Carry out complete immunization schedule again if bitten by a suspected rabid animal.③ Complete postexposure immunization schedule was conducted within the last 3 years, and followed by boosters: One dose of vaccine shall be given on day 0 and 3, separately, if bitten by a suspected rabid animal.④ Complete 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] 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.[Contraindications] (1) Because rabies is a fatal disease, there is no contraindication for postexposure immunization.(2) For pre-exposure immunization, it is not recommended to immunize eligible individuals with fever, acute diseases, severe chronic diseases, nervous systematic disease and allergic diseases or with a history of allergic reactions to antibiotics and/or biological products. It is recommended to postpone the administration of the vaccine for women in pregnancy or in lactation, if feasible.[Precautions] (1) Do not use the vaccine if the container shows abnormalities, such as crack, illegible label, and foreign matters.(2) Alcoholic drinks, strong tea, pungent food and strenuous exercise shall be avoided after injection of the vaccine.(3) Injection of the vaccine in the gluteal region is prohibited. Do not inject the vaccine intravascularly.(4) Freezing of the vaccine is strictly forbidden.(5) Use the vaccine before the expiry date marked on the vial label or box label.[Storage] Store and ship the product at 2-8℃, protected from light.[Package] The packing material contacting this product directly is 2 ml vial made of borosilicate glass.5 vials / human dose × 1 human dose / box[Validity period] 12 months
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