ALBUMIN 5% is a sterile, fluid preparation of albumin obtained from large pools of human plasma. All devices of human plasma used in the manufacture of ALBUMIN 5% are supplied by FDA accepted blood establishments only. The production procedure consists of final container pasteurization and extra mass pasteurization at 60 +/- 0. 5 C for 10, 11 hours. The ALBUMIN 5% manufacturing process provides a substantial viral reduction in vitro researches. No treatment, nonetheless, has been revealed to be entirely reliable in eliminating viral infectivity from derivatives of human plasma. [see Precautions and warnings, Infection Risk from Human Plasma] Table 2 In vitro reduction element during ALBUMIN 5% manufacturing. HIV-1: Human Immunodeficiency Virus, 1. Reo 3: Reovirus Type 3. HAV: Hepatitis A Virus. The make-up of ALBUMIN 5% is as adheres to: Protein, of which above or equal to 96% is human albumin. ALBUMIN 5% has no chemicals and components used in its packaging are latex-free.
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