Active Ingredient: Immunoglobulins, normal human, IV
Immunomodulation in adults, and children and adolescents in primary immune thrombocytopenia (ITP), in patients at high risk of bleeding or prior to surgery to correct the platelet count.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Intravenous, between 0.8 grams immunoglobulins, normal human, IV per kilogram of body weight and 1 grams immunoglobulins, normal human, IV per kilogram of body weight, once every 3 days, 1 to 2 doses in total.
Regimen B: Intravenous, 0.4 grams immunoglobulins, normal human, IV per kilogram of body weight, once daily, over the duration of 2 to 5 days.
There are two alternative treatment schedules:
The treatment can be repeated if relapse occurs.
Human normal immunoglobulin should be infused intravenously at an initial rate of 0.5 ml/kgBW/hr for 30 minutes. If well tolerated, the rate of administration may gradually be increased to a maximum of 6 ml/kgBW/hr.
Clinical data obtained from a limited number of patients also indicate that adult PID patients may tolerate an infusion rate of up to 8 ml/kg BW/hr.
Any infusion-related adverse events should be treated by lowering infusion rates or by stopping the infusion.
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