Description

Immunoglobulin Normal, Human (ImmunoRel) is available in 5% concentration solution in 50 mL and 100 mL preparations.
Each mL contains: Protein content 50 mg/mL, Immunoglobulin G ≥ 95%, Stabiliser Maltose 100 mg/mL, IgA content ≤ 0.08 mg/mL.
Immunoglobulin sub class: Normal distribution.
Immunoglobulin Normal, Human (ImmunoRel) is a solvent/detergent treated, sterile, preparation of chromatographically purified immunoglobulin G (IgG) derived from pooled human plasma. The product is manufactured by modified Cohn’s fractionation process followed by ultra-filtration and ion exchange chromatography. The manufacturing process includes treatment with an organic solvent detergent mixture composed of Tri-n-butyl phosphate and TritonX-100. The manufacturing process provides a significant viral reduction as confirmed by in-vitro studies.
The manufacturing process isolates IgG without additional chemical or enzymatic modification and the Fc portion is maintained intact. This contains all the IgG antibody activities against bacterial and viral agents that are capable of opsonisation and neutralisation of microbes and toxins, which are present in the normal donor population. The IgG subclass distribution is also very similar to that in normal plasma. This product contains small amounts of IgA (≤ 80 mg/L). Maltose is used as a stabiliser in the concentration of 100g/L.