Intragam - Model P -Human Normal Immunoglobulin
Intragam P is a sterile, preservative-free solution containing 6 g of human protein in each 100 mL. At least 98% of the protein has the electrophoretic mobility of immunoglobulin G (IgG). At least 90% of the protein is IgG monomer and dimer.
Based on three preclinical and four clinical batches, the distribution of IgG subclasses present in Intragam8 P is, on the average, 61% IgGi, 36% IgCfc, 3% IgGs and 1% IgG4.
Intragams P contains only trace amounts of IgA (nominally
Intragam P is manufactured from human plasma donated by New Zealand`s voluntary and non-remunerated donors.
Intragams P contains 10 g of maltose in each 100 mL.
For the full list of excipients, see section 6.1.
PHARMACEUTICAL FORM
Intragams P is a solution for intravenous infusion.
Intragam8 P is isotonic, with an approximate osmolality of >240 mOsmkg.
The solution has a pH of 4.25.