Posology : מינונים

3          DOSAGE AND ADMINISTRATION
Posology
Post-exposure prophylaxis consists of a regimen of one dose of immunoglobulin and full courses of rabies vaccination. Rabies immunoglobulin and the first dose of rabies vaccine should be given as soon as possible after exposure. Additional doses of rabies vaccine should be given according to official guidelines or the manufacturer’s instructions.
Rabies prophylaxis exclusively with simultaneous vaccination: recommended dose of rabies immunoglobulin is 20 IU/kg body weight, preferably at the time of the first vaccine dose. It may also be given through the seventh day after the first dose of vaccine is given.
KamRAB should never be administered in the same syringe or into the same anatomical site as the vaccine.
Because of the risk of interference with antibody production related to vaccination, neither the dose should be increased, nor a repeated rabies immunoglobulin dose be given (even if the onset of the simultaneous prophylaxis is delayed).
Method of Administration
Human rabies immunoglobulin should be administered via the intramuscular route.
If a large volume (>2 ml for children or >5 ml for adults) is required, it is recommended to administer this in divided doses at different sites.
KamRAB should never be administered in the same syringe or into the same anatomical site as the vaccine.
The wound should be cleaned with soap and disinfectant.
KamRAB should preferably be administered in the bitten site. KamRAB should be carefully infiltrated as much of the dose as is anatomically possible in the area in the depth of and around the wound. Any remainder should be injected intramuscularly into the upper arm deltoid region or in small children into the anterolateral aspect of the thigh. Administration should be opposite the site of the rabies vaccine. Passive immunization into the gluteal region; where absorbance is unpredictable, should be avoided.
If intramuscularly administration is contra-indicated (bleeding disorders) the injection can be administered subcutaneously. However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route.
Rabies Postexposure Prophylaxis
Local or state public health officials should be consulted if questions arise about the need for rabies prophylaxis.
Local treatment of wounds: Immediate and thorough washing of all bite wounds and scratches with soap and water is perhaps the most effective preventative measure for preventing rabies.
Recommended first-aid procedures include immediate and thorough flushing and washing of the wound for a minimum of 15 minutes with soap and water, detergent, povidone iodine or other substances of proven lethal effect on rabies virus (WHO).
Tetanus prophylaxis and measures to control bacterial infection should be given as indicated.


4          DOSAGE FORMS AND STRENGTHS
KamRAB is supplied in single-dose vials containing 2 mL, 5 mL, or 10 mL of ready-to-use solution with a nominal potency of 150 IU/mL (Note that more than one vial may be required for a single patient treatment).
•   The 2 mL vial contains a total of 300 IU, which is sufficient for a child weighing 15 kg
•   The 5 mL vial contains a total of 750 IU, which is sufficient for an individual weighing 37.5 kg
•   The 10 mL vial contains a total of 1500 IU, which is sufficient for an adult weighing 75 kg The final product is assayed with human rabies immunoglobulin reference standard that is calibrated against the WHO International Standard.