V-IMMUNE: A Novel Immunoglobulin Therapy for Immunodeficiency

"The investigational product is V-IMMUNE®, a 5% human normal immunoglobulin I.P. (5 g/100 mL) manufactured from qualified human plasma for intravenous use. Each vial contains human immunoglobulin at 50 g/L, maltose at 100 g/L, and water for injection. The 5% Human Immunoglobulin Solution for Intravenous Administration (I.P.) is a sterile and pyrogen-free preparation of human normal immunoglobulin in a single-dose form for intravenous administration. Each 10 mL, 50 mL, or 100 mL vial contains 0.5 g, 2.5 g, or 5 g of human normal immunoglobulin, respectively, and is produced from qualified human plasma using membrane filtration and a combination of chromatographic steps and viral inactivation procedures. The IgA content does not exceed 2 mg/mL.~This manufacturing process uses plasma collected from donors who undergo screening according to guidelines set by regulatory authorities. Blood is tested for all mandatory infectious diseases."