Ra-Gam

RA-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.

COMPOSITION:

Each 100 mL bottle of RA-GAM 5 % contains 5 g(50 g /L) of Human Normal Immunoglobulin for IV Use.

• 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.

CLINICAL PHARMACOLOGY:

Immunoglobulin G (IgG) is a major Isotype of antibodies present in the human blood and extracellular fluid allowing it to control infection of body tissues. 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).

HOW SUPPLIED:

Aqueous solution containing 5% IgG in 100 mL bottle.

STORAGE & SHELF LIFE:

• Store the bottle in original carton between 2 C to 8 C.
• Protect from light. Do not freeze. Keep out of reach of children.
• RA-GAM 5 % is stable for three years when stored at recommended storage conditions