“May all be happy, may all be healed, may all be at peace and may no one ever suffer."
Rabies Vaccine for human use is a freeze-dried preparations of inactivated rabies virus produced on Vero cell. After reconstitution the vaccine is a clear, colorless sterile solution for intramuscular use.
Rabies vaccine is indicated for prophylactic immunization against rabies and treatment of patients following suspected rabies contact.
Pre-exposure Immunization:
Post-exposure Immunization:
Dosage
To reconstitute the vaccine, transfer content of supplied diluent into the vial containing freeze-dried preparation. Do not shake. After reconstitution the solution should be homogeneous, clear and free from any particles. Vaccine must be injected immediately after reconstitution and the syringe should be destroyed after use.
Method of administration for intramuscular use: The 1 ml dose of Rabies vaccine should be given intramuscularly in the deltoid in adults and in the anterolateral aspect of the thigh muscle in children under 1 year. It should not be injected into the gluteal region. Do not inject intravenously.
Pre-exposure immunization:
Post-exposure immunization:
Intramuscular schedules: One Intramuscular (IM) dose comprised of 1 ml.
Standard intramuscular (1-1-1-1-1) regimen:
Or abbreviated multisite (2-1-1) regimen:
In case of severe (WHO category 3) wounds, rabies immunoglobulin should be administered as soon as possible with the first dose of rabies vaccine. The anti-rabies immunoglobulin should be used as local wound soakage injections 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 immunized: Patients had complete post exposure immunization schedule within 1 year. Bitten by suspected rabid animal, 1 dose injection is required on Day 0, Day 3, respectively. Patients had complete post-exposure immunization schedule 1 year ago, Bitten by suspected rabid animal, complete post-exposure immunization required. Patient had complete immunization schedule and booster immunization within 3 years. Bitten by suspected rabid animal, 1 dose injection is required on Day 0, Day 3, respectively. Patient had complete immunization schedule and booster immunization 3 years ago. Bitten by suspected rabid animal, complete post-exposure immunization required. Post-exposure vaccination must be administered on the basis of severity under medical supervision.
Administration
Co-administration: Corticosteroid and immunosuppressive treatment may interfere with antibody production and cause vaccination failure. In these cases, a titration of neutralizing antibodies should be performed.
Rabies vaccine is contraindicated in the following cases:
Pre-exposure: Severe fever, febrile infection, acute disease, progressive chronic diseases. Known hypersensitivity reactions to rabies vaccine or any of its components
Post-exposure: No contraindication to post-exposure treatment, because rabies is lethal disease, any contraindication to exposure, treatment should be considered carefully before disqualifying an individual for anti-rabies treatment.
Minor local reactions like pain, erythema, oedema, pruritus and induration at the injection site and lasting to 24-48 hours. Moderate fever, shivering, fainting, asthenia, dizziness, respiratory manifestations (dyspnoea, wheezing), fever, abdominal pain, vomiting and allergic skin reactions (urticaria, rash, itching).
Pregnancy. The potential risk of administration of rabies vaccine during pregnancy is unknown. Due to the severity of the disease, pregnancy is not considered to be a contraindication to post-exposure prophylaxis.
Lactation: It is not known whether the vaccine is excreted in human breast milk. Due to the severity of the disease, breast-feeding is not considered a contraindication.