Fibryga Powder, For Solution
Product Images NDC 68982-349

Product Visual Gallery

This gallery contains 22 technical images submitted to the FDA as part of the official labeling for Fibryga (NDC 68982-349). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Octapharma Usa 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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This text provides a formula for calculating the dose of a medication based on the difference between the target fibrinogen level and the measured fibrinogen level in the blood. The formula calculates the dose in milligrams per kilogram of body weight using a factor of 18.*

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This text provides a formula for calculating the dose of a medication in milligrams per kilogram of body weight based on the difference between the target fibrinogen level and the measured fibrinogen level. The formula multiplies this difference by 1.4 mg/dL per mg/kg body weight to determine the appropriate dosage.*

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This text mentions an empty diluent and a reconstituted product called FIBRYGA. It appears to refer to a process involving dilution and reconstitution of a substance. The text also includes a reference to a figure (Fig. 5) which may provide further details or visuals related to the process.*

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This text provides incomplete information. Without further context, it is not possible to provide a useful description. It appears to mention a product called "FIBRYGA" and could possibly refer to a reconstituted bottle of this product. Additional details or clarity are needed to determine the exact meaning of the text.*

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This text is not readable.*

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This text appears to be a table showing the production step and the corresponding virus reduction factors for different types of viruses including enveloped and non-enveloped viruses. The data includes information about specific viruses such as HIV, PRV, BVDV, HAV, and PPV, as well as the methods used for virus reduction such as S/D treatment and Nanofiltration. The table also indicates cumulative virus reduction factors.*

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This text provides a comparison of pharmacokinetic parameters among different age groups (adult and adolescent patients, pediatric patients aged 6 to <12 years, and pediatric patients under 6 years of age). The parameters evaluated include half-life, Cmax (maximum concentration), AUC (area under the curve), AUCsemm for a dose of 70 mg/kg, incremental IVR, clearance, mean residence time, and volume of distribution at steady state. The data includes mean values, standard deviations, and ranges for each parameter, helping to understand how the drug behaves in different populations.*

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This text is not available.*

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This is a reference to a diluent for FIBRYGA in a bottle, as shown in Figure 4.*

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This is a reference to using an empty diluent to reconstitute a FIBRYGA bottle. Figure 5 might provide visual instructions or guidance related to this process.*

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This is not-available.*

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This is not-available*

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This is a description for a medical product called FIBRYGA, which is a lyophilized powder for reconstitution used for intravenous administration to treat fibrinogen deficiency. It is advised to store the product protected from light and not freeze it. The product information includes the lot number, expiration date, NDC number, and instructions on storage and administration. For more details on dosage and administration, it is recommended to refer to the package insert or contact the manufacturer at 866-766-4860.*

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