Rabivax 2.5IU/ml

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 1ml 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.

Method of administration for intradermal use: The 0.1 ml dose of Rabies vaccine (per site) should be administered intradenmally in the upper arm, over the deltoid.

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
• 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

Intradermal schedules: One intradermal (ID) dose is comprised of 0.1 ml.

Thai Red Cross (2-2-2-0-1-1) schedule:

• Day 0: 2 injection each of 0.1 ml at separate sites
• Day 3: 2 injection each of 0.1 ml at separate sites
• Day 7: 2 injection each of 0.1 ml at separate sites
• Day 28: 1 injection of 0.1 ml Day 90:1 injection of 0.1 ml (optional).

Or

WHO Modified Thai Red Cross (2-2-2-0-2) schedule:

• Day 0: 2 injection each of 0.1 ml at separate sites
• Day 3: 2 injection each of 0.1 ml at separate sites
• Day 7: 2 injection each of 0.1 ml at separate sites
• Day 28: 2 injection each of 0.1 ml at separate sites

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 immunized subjects: If vaccine administered in less than 5 years of exposure (cell culture rabies vaccine): 2 injections one on each of DO, D3. If vaccine administered in more than 5 years of exposure or incomplete vaccination: 5 injections on DO, D3, D7, D14 and D28 with administration of immunoglobulin if 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-

Touching or feeding of animal, licks on intact skin:

• Recommended treatment: None, if reliable case history is available.

Nibbling of uncovered skin, minor scratches, superficial bites (except on head, neck, shoulder girdle.arms or hands) or abrasions without bleeding, licks on broken skin:

• Recommended treatment: Administer vaccine immediately on Day 0, D3, D7, D14 and D28.Stop treatment if animal remains healthy throughout the observation period of 10 days or if animal is killed humanely and found to be negative by appropriate laboratory techniques.

Single or multiple transdermal bites or scratches specially on head, neck, shoulder girdle,arms or hands. Contamination of mucus membrane with saliva (i.e. licks on broken skin):

• Recommended treatment: Administer rabies immunoglobulin immediately with the first dose of rabies vaccine. Administer rabies vaccine on Day 0, D3, D7, D14 and D28 or D90 (optional). Stop treatment if animal remains healthy throughout the observation period of 10 days or if animal is killed humanely and found to be negative by appropriate laboratory techniques