Rabivax

Indication

Rabies vaccine is indicated for prophylactic immunization against rabies and treatment of patients following suspected rabies contact.

Pre-exposure immunization

• This vaccination is particularly recommended for:
• Professional groups exposed to frequent contamination
• Veterinary surgeons (including students at veterinary colleges)
• Technical personnel working with veterinary surgeons
• Laboratory personnel handling material contaminated with rabies virus
• Personnel in abattoirs and knackers yards
• Taxidermists
• Gamekeepers, forestry workers and naturalists in enzootic areas
• Infants particularly exposed to the risk of rabies

Post-exposure immunization

• Treatment of subjects bitten by rabid animals or those suspected of being so
• Treatment of contact subjects

Dosage & Administration

To reconstitute the vaccine, transfer content of supplied diluent into the vial containing freeze-dried preparation. 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 Rabivax 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.

(a) Pre-exposure immunization:

1 ml for children and adults.

Primary-vaccination:

According to the WHO recommendations 1 injection by the intramuscular route on days D0, 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 IU/ml

(b) Post-exposure immunization:

Local treatment of the wound:

1. Prompt and gentle

through washing with

soap or detergent and

flushing the wound with

running tap water for at

least 15 minutes

2. After washing, disinfectants

like either ethanol (700 ml/l) or

tincture or aqueous solution of

iodine or povidone iodine must

be applied

3. 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.

WHO guidelines on post-exposure treatment depending on wound severity

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.

Precautions

1. Intravenous injection is prohibited.

2. The vaccine and anti-rabies immunoglobulin must not be administered with same syringe and in the same injection site.

3. Before use, please carefully check package, label, appearance and the validity period.

4. After reconstitution, the freeze-dried rabies vaccine should be administered as soon as possible.

5. 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.

Pregnancy and Lactation

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 contra-indication 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 contra-indication.

Side Effects

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).