Gammaked Injection
Product Images NDC 76125-900

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Gammaked (NDC 76125-900). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Kedrion Biopharma, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

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Figure 7 (Figure7)

This is a graph that shows the concentration of plasma total IgG in mg/mL over time following different modes of administration (IV, SC) of an unknown substance. There is also a projected line for SC administration. However, without additional context, it is impossible to determine the exact substance being administered or the purpose of the study.*

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Figure 8 (Figure8)

This is a graph showing the time to relapse during a randomized withdrawal period for patients taking GAMMAKED (n=31) compared to placebo (n=26). The secondary endpoint p-value for time to relapse is 0.011, based on a log-rank test. The x-axis shows time in weeks and the y-axis shows the percentage of patients who relapsed. There is also a table next to the graph displaying the number and percentage of patients who relapsed at various time points.*

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100 mL Carton (Gammakedcarton)

This is a description of a medication called Gammaked, an immune globulin injection used for intravenous or subcutaneous administration. It comes in a package that includes a single-dose vial with a dosage and administration guide. The product has no preservatives, has 98% immunoglobulin, and around 15 mg of glycoprotein. The medication should be discarded if there is tampering or if the seal is absent. The manufacturer is Grifols Therapeutics LLC. The medication should be stored between 2-8°C and not exceed 25°C. If stored properly, the product has a shelf life of 36 months.*

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Administration (Pi Admin2)

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100 mL Vial (Vial)

Gammaked is an injection solution for infusion, used for intravenous or subcutaneous administration, with dosage and administration information included in the packaging. Storage at temperatures between 2-8°C for up to 24 months is recommended. The product must be used immediately upon opening. Lot and batch number information is provided on the packaging. Patient and physician discussions about the risks and benefits of the product are recommended.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.