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Immunoglobulin and Hemolysis 3

    Basic Details
    Date Posted
    Medical Product
    immunoglobulin (Ig)
    Health Outcome(s)

    Modular program-based one-time assessment of hemolysis events following new use of several immunoglobulin products, including Flebogamma, Gammagard liquid, Gammaplex, Gamunex, Octagam, Privigen, Lyophilized product IV, Non-lyophilized intramuscular, Non-lyophilized unspecified route, and other intravenous immunoglobulin (IVIg) products.  The query was run against the Mini-Sentinel Distributed Database for the time period of January 1, 2006- December 31, 2012. Modular programs are adaptable standardized programs.  Results were generated using Modular Program 6, version 6.0; click here for more information. The queries were distributed to 18 Data Partners in October 2013.

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    Additional Details
    FDA Center
    Time Period
    2006 - 2012
    Data Sources
    Mini-Sentinel Distributed Database (MSDD)