RENO-GAM Human Normal Immunoglobulin for Intravenous Use I.P. (IVIG) is a sterile, 5% liquid preparation of Immunoglobulin G (IgG) purified from a large pool of human plasma for fractionation. The product is manufactured by a series of chromatography based purification process. The manufacturing process includes dedicated viral inactivation and removal steps such as treatment with TNBP and Triton X-100, low pH treatment and Nanofiltration.
Stabilizer Maltose :10%
IgA content: ≤ 4 mg/L
IgM content : ≤ 0.1mg/L
Contains no preservatives.
Immunoglobulin G sub class distribution is normal. Source: Human Plasma for Fractionation that is , non –reactive for HBs Antigen,, HCV, HIV 1&2 antibodies and negative for the viruses, HIV1 &2, HCV and i.e. HBV using NAT.
IgG has several immunomodulating activities that include modulation of complement activation; suppression of idiotypic antibodies; saturation of Fc receptors on macrophages; and suppression of various inflammatory mediators, including cytokines, chemokines, and metalloproteinases. The Fc region of IgG facilitates interaction with and signaling through Fc receptors on phagocytes, B cells, and other cells and with Fc-binding plasma proteins (eg, components of the complement system).
Protect from light. Do not freeze. Keep out of reach of children.
RENO-GAM 5 % is stable for three years when stored at recommended storage conditions