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DIRECTIONS FOR USE OF RABIES VACCINE (VERO CELLS) FOR HUMAN USE, FREEZE-DRIED
[Drug Name ]
Adopted name: Rabies Vaccine (Vero cells) for Human Use, Freeze-dried
[Constituents and characters]
The vaccine is a freeze-dried preparation of rabies fixed virus grown in Vero cells. After cultivation and harvest, the virus suspension is inactivated, concentrated and purified, and lyophilized after the addition of a suitable stabilizer. It looks like a white crisp cake. After reconstitution it turns into a clear liquid containing 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 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.
[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]
Because rabies is a fatal disease, there are no contraindications for post-exposure immunization.
For pre-exposure immunization, it is not recommended to immunize eligible individuals with fever, acute disease, serious chronic disease, and with a history of allergic reaction to antibiotics and/or biological products. It is recommended to postpone the administration of the vaccine for women in pregnancy or in location, if feasible.
[Precautions]
Do not use the vaccine if the reconstituted vaccine contains any foreign substance, or any leakage of container or illegible is found.
Alcoholic drinks, strong tea, pungent food and strenuous exercise shall be avoided after injection of the vaccine.
Do not inject the vaccine in the gluteal region.
[Storage]
Store and ship at or below 8°C, protected from light.
[Packaging]0.5 ml/dose 5 doses + 5 doses sterilize water for injection
Rabies Vaccine (Vero cell) for Human Use,Freeze-dried