AIM Vaccine Co., ltd.

[Drug Name] Generic name: Rabies Vaccine (Vero Cell) for Human Use, Freeze-dried

[Ingredients and Properties] This product is made from the rabies virus fixed strain aGV that is inoculated onto Vero cells, then cultured, harvested, concentrated, inactivated, and purified. Human serum albumin, sucrose, and gelatin are added as stabilizers before freeze-drying. It is a white, fluffy substance that becomes a clear liquid upon reconstitution and does not contain any preservatives.

Active ingredient: Inactivated rabies virus fixed strain aGV.

Excipients: Human serum albumin, gelatin, sucrose.

Vaccine diluent: Sterile injectable water.

[Vaccination Target] In the event of a bite or scratch from a rabid or mad animal, regardless of age or gender, the local wound should be immediately treated (rinsed repeatedly with water or soapy water, then disinfected several times with iodine tincture or alcohol, and this vaccine should be administered in a timely manner according to the post-exposure immunization schedule); individuals at risk of exposure to the rabies virus (such as veterinarians, animal handlers, forestry workers, slaughterhouse workers, rabies laboratory personnel, etc.) should be vaccinated according to the pre-exposure immunization schedule.

[Effects and Uses] After vaccination with this vaccine, it can stimulate the body to produce immunity against the rabies virus. It is used to prevent rabies.

[Specifications and Potency] Each vial is 1.0ml after reconstitution. The dosage for one person is 1.0ml, and the potency of the rabies vaccine should not be less than 2.5 IU.

[Immunization Schedule and Dosage]

(1) Add the indicated amount of sterilized injectable water, allow the vaccine to reconstitute and shake well before injection.

(2) Administer by intramuscular injection into the deltoid muscle of the upper arm, or if necessary, into the anterolateral area of the thigh.

(3) Post-exposure immunization schedule: For a typical bite, administer one dose of this vaccine on day 0 (day 1, the day of the bite), day 3 (day 4, and so on), day 7, day 14, and day 28. A total of 5 doses are administered for complete immunization, with the same dosage for children, adults, and the elderly.

(4) Pre-exposure immunization schedule: The basic immunization schedule before exposure is one dose of rabies vaccine at a single site on day 0 and day 7. Details on doubling the first dose and recommendations for re-exposure are provided in the instructions.

[Adverse Reactions]

Common adverse reactions:

Redness, swelling, pain, itching, mild fever, weakness, headache, dizziness, joint pain, muscle pain, vomiting, abdominal pain, and other similar symptoms may occur at the injection site, which generally do not require treatment and will subside on their own. Rare and very rare adverse reactions are detailed in the instructions.

[Contraindications] Since rabies is a fatal disease, there are no contraindications for vaccination with this vaccine after exposure. Contraindications for pre-exposure vaccination are detailed in
the instructions.

[Storage] Keep at 2-8°C away from light for storage and transportation.

[Shelf Life] 36 months

[Precautions] [Packaging] [Execution Standard]
[Approval Document No.] See the instructions for details.