FRACTION CONTAINING IMMUNOGLOBULIN-G

摘要

1. Immunoglobulin-G-containing fraction from human or animal plasma for intravenous application, characterised in that it contains : at least 90% monomeric IgG molecules, at least 95% gammaglobulins, at least 90% functionally intact IgG molecules, i. e., at least 90% IgG molecules capable of binding to protein A of Staphylococcus aureus, it has an anticomplementary activity of at least 40 mg protein for neutralisation of a C'H-50 unit, and it is substantially free of vasoactive and leucopenically active as well as bronchospastic substances expressed by the following characteristic features : a) that the vasoactive effect, in dog test as an average of four animals, i. e., a blood pressure decrease by 30% at most, is detectable only at a dose of more than 500 mg/kg body weight, b) that the leucopenic effect, in dog test as an average of four animals, i. e., a decrease of the leucocyte number of 50% at most, is detectable only at a dose of more than 500 mg/kg body weight, and c) that the bronchospastic effect, in guinea pig test as an average of four animals, i. e., an increase in the respiratory pressure by 30% at most, is detectable only at a dose of more than 500 mg/kg body weight.