Rabivax IM/SC Injection

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.

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:

• 1 ml for children and adults.
• Primary-vaccination: According to the WHO recommendations 1 injection by the intramuscular route on days DO, D7, D21 or D28, followed by a booster dose one year later.
• Boosters: Thereafter, one injection every 5 years or when the titre is found to be less than 0.5 lU/ml

Post-exposure immunization:

• Local treatment of the wound: Prompt and gentle through washing with soap or detergent and flushing the wound with running tap water for at least 15 minutes. After washing, disinfectants like either ethanol (700 ml/l) or tincture or aqueous solution of iodine or povidone iodine must be applied. Don't bandage or suture the wound.
• Vaccination of non-immunized subjects

Intramuscular schedules: One Intramuscular (IM) dose comprised of 1 ml.

Standard intramuscular (1-1-1-1-1) regimen:

• Day 0: 1 injection of 1 ml
• Day 3: 1 injection of 1 ml
• Day 7: 1 injection of 1 ml
• Day 14: 1 injection of 1 ml
• Day 28: 1 injection of 1 ml

Or abbreviated multisite (2-1-1) regimen:

• Day 0: 2 injections each of 1 ml at separate sites
• Day 7: 1 injection of 1 ml
• Day 21: 1 injection of 1 ml

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.

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.

Concurrent use with immunosuppressants may reduce the efficacy of vaccines.

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.

• Intravenous injection is prohibited.
• The vaccine and anti-rabies immunoglobulin must not be administered with same syringe and in the same injection site.
• Before use, please carefully check package, label, appearance and the validity period.
• After reconstitution, the freeze-dried Rabivax should be administered as soon as possible.
• Any reconstituted vaccine should be used as soon as possible. It must be stored in a refrigerator at 2°C to 8°C and used within 8 hours after reconstitution or discarded.

Vaccines, Anti-sera & Immunoglobulin

Keep out of the reach and sight of children. Store & transport at 2°C to 8°C. Protect from light. Do not keep in the deep freeze.