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.
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.
RENO-GAM 5 % is stable for three years when stored at recommended storage conditions
COMPOSITION:
Each 100mL bottle of RENO-GAM 5% contains 5g(50g /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.
Reno-ALB 20% is a nonpyrogenic, sterile aqueous solution of Human Albumin I.P. for intravenous administration and is purified from pooled human venous plasma using a series of chromatography steps.
COMPOSITION:
Each 100 mL RENO-ALB 20 % vial contains.
Total protein- 200g/L
N- Acetyl tryptophan – (0.016M)
sodium caprylate – (0.016M)
Na+ -145 ± 15 mEq/L
K+ – ≤ 2m Eq/
aluminium content – ≤ 200 µg/L
RENO-ALB 20% is produced from pooled human plasma for fractionation conforming to the highest standards set forth by regulatory authorities. In addition, the plasma donor units and the production plasma pool are tested negative using NAT approved by regulatory authorities for HIV1& 2, HCV and HBV.
CLINICAL PHARMACOLOGY
Albumin accounts for 70-80% of the colloid osmotic pressure of plasma involved in regulating the circulating blood volume and this is the primary reason for its clinical use. In addition, it also functions as a carrier protein for several hydrophobic steroid hormones and fatty acids.Human Albumin is a highly stable and globular protein of molecular weight 66,500. The total body albumin in a 70 kg man is approximately 320 g. It is distributed throughout the extracellular compartments and more than 60% of the body albumin pool is located in the extravascular fluid compartment. Albumin has a circulating life span of 15-20 days, with a turnover of approximately 15 g per day.
