Active Ingredient: Immunoglobulins, normal human, IV
Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF)* or serum IgG level of <4 g/l.
* PSAF = failure to mount at least a 2-fold rise in IgG antibody titre to pneumococcal polysaccharide and polypeptide antigen vaccines
For this indication, competent medicine agencies globally authorize below treatments:
For:
Intravenous, between 0.2 grams immunoglobulins, normal human, IV per kilogram of body weight and 0.4 grams immunoglobulins, normal human, IV per kilogram of body weight, once every 3 to 4 weeks.
The recommended dose is 0.2-0.4 g/kg every three to four weeks.
IgG trough levels should be measured and assessed in conjunction with the incidence of infection. Dose should be adjusted as necessary to achieve optimal protection against infections, an increase may be necessary in patients with persisting infection; a dose decrease can be considered when the patient remains infection free.
Human normal immunoglobulin should be infused intravenously at an initial rate of 0.5 ml/kg BW/hr for 30 minutes. If well tolerated (see section 4.4), 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/kgBW/hr.
Any infusion-related adverse events should be treated by lowering infusion rates or by stopping the infusion.
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