Active Ingredient: Immunoglobulins, normal human, IV
Immunomodulation in adults, and children and adolescents in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, in total 2 grams immunoglobulins, normal human, IV per kilogram of body weight, over the duration of 2 to 5 days. Afterwards, intravenous, 1 grams immunoglobulins, normal human, IV per kilogram of body weight, every 3 weeks, 1 to 2 doses in total, over the duration of 6 months.
Starting dose: 2 g/kg divided over 2-5 consecutive days.
Maintenance doses: 1 g/kg over 1-2 consecutive days every 3 weeks.
The treatment effect should be evaluated after each cycle; if no treatment effect is seen after 6 months, the treatment should be discontinued. If the treatment is effective long term treatment should be subject to the physicians discretion based upon the patient response and maintenance response. The dosing and intervals may have to be adapted according to the individual course of the disease.
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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