Description

1 mL contains: Human Immunoglobulin-G (active ingredient) 50 mg, Maltose (stabilizer) 100 mg, Water for Injection (solvent) q.s.
This product ‘IV-Globulin SN Inj. (Human Normal Immunoglobulin in maltose, pH 4.25)’, as a biological product, is manufactured with plasma which was collected for the purpose of manufacture of plasma derivatives from individual donors. All plasma processes thawing, cold ethanol fractionation and virus inactivation processes such as S/D treatment and nano-filtration. Fraction II which comes from plasma fractionation is purified with chromatography. and takes S/D treatment for virus inactivation. Another purification process with chromatography is taken and dia-filtration is conducted. Nano-filtration process follows in order to remove viruses and bulk product is produced. Final bulk is manufactured by adding maltose (as stabilizer) to bulk product and passing through sterile filter, after this final bulk is filled into vials.