PlasmaGlob 10 is Normal Human Immunoglobulin, 10% in 50 mL & 100mL for Intravenous use prepared from Indian Human Plasma from healthy voluntary donors, by Cohn Fractionation/ Chromatography process. Each unit of plasma is tested for all mandatory serological markers prescribed by National Regulatory Authority (NRA).
To increase safety profile of PlasmaGlob 10, the plasma used in its manufacturing and final product undergoes extensive testing from various protocols HBsAg, Ab-Ag HIV, anti-HCV by ELISA and for HBV-DNA, HCV-DNA, HAV-RNA, HIV-RNA, Parvovirus B19-DNA by NAT/PCR.
Only the non-reactive plasma units were used for manufacturing of PlasmaGlob. To further improve the margin of safety effective viral inactivation steps like solvent detergent treatment have been integrated into the manufacturing and formulation process. PlasmaGlob has undergone two steps of viral inactivation. As per the regulatory norms and Hemovigilance program, the record of plasma used in manufacturing of PlasmaGlob has been maintained for 10 years.
PlasmaGlob 10 is Glycine stabilized IVIG, tested, developed, and documented in EU associates and other international markets and contains no preservatives.
- Primary Immune Deficiency Diseases (PIDDs)
- Idiopathic Thrombocytopenic Purpura(ITP)
- Kawasaki Disease(KD)
- Guillain-Barré Syndrome(GBS)
- Chronic Lymphocytic Leukemia (CLL)
- Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- Bone Marrow Transplantation (BMT) – for prevention of graft vs host disease
- Store at 2 to 8°C
- Protect from light
- Do not freeze
36 months from the date of manufacture