Bortezomib Injection, Powder, Lyophilized, For Solution
Product Images NDC 55150-337

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Bortezomib (NDC 55150-337). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Eugia Us Llc, 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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Formula 1 (Bortezomib Fig1)

This text provides a formula for calculating the total volume of Bortezomib medication to be administered based on the patient's body surface area. The formula involves multiplying the dose of Bortezomib in milligrams per square meter (mg/m²) by the patient's body surface area in square meters (m²). The result will give the total volume of Bortezomib to be administered, considering that the concentration of Bortezomib solution is 1 milligram per milliliter (1mg/mL).*

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Package Label-principal Display Panel-3.5 mg Per Vial (Container-Carton (1 Vial))

This is a product information sheet for Bortezomib for Injection, used for intravenous or subcutaneous administration at a concentration of 3.5 mg per vial. The medication is stored between 20° to 25°C and should be protected from light. Detailed reconstitution instructions can be found on the back of the package. It is distributed by Eugia US LLC and manufactured by Eugia Pharma Specialties Limited in India. The vial stopper does not contain natural rubber latex. The document also includes the NDC code, dosage information, and contact details for the distributor.*

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Package Label-principal Display Panel-3.5 mg Per Vial (Sticker Label)

This text relates to the instructions for preparing Bortezomib for Injection, subcutaneous injection, and intravenous injection. It provides details on adding a specific volume of 0.9% Sodium Chloride to achieve final concentrations of 2.5 mg/mL and 1 mg/mL. Stickers are included to be placed on the vial or syringe. For full instructions, the user is directed to refer to the Package Insert (Section 2).*

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Figure 12 (Bortezomib Fig12)

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Formula 1 (Bortezomib Fig2)

This text provides information on calculating the total volume of Bortezomib to be administered based on the dose in mg/m^2 and patient's body surface area in m^2. The concentration of Bortezomib for injection is given as 2.5 mg/mL. This formula helps in determining the correct volume of Bortezomib to be given to the patient.*

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Figure 1: Time To Progression Bortezomib, Melphalan And Prednisone Vs Melphalan And Prednisone (Bortezomib Fig3)

This text does not provide a clear description.*

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Figure 2: Overall Survival Bortezomib, Melphalan And Prednisone Vs Melphalan And Prednisone (Bortezomib Fig4)

This text seems to contain data related to the percentage of patients at risk, the number of patients at risk over specified time points, and the log-rank test results. The information includes the time in months, the number of patients remaining at different time points, and p-values. It is likely part of a statistical analysis or a study examining patient outcomes over time.*

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Figure 3: Time To Progression Bortezomib Vs Dexamethasone (relapsed Multiple Myeloma Study) (Bortezomib Fig5)

This is a table indicating the proportion of patients taking Bortezomib and Dexamethasone over different time points in days. The table includes the number of patients remaining after each indicated time point and a p-value from a log-rank test.*

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Figure 4: Overall Survival Bortezomib Vs Dexamethasone (relapsed Multiple Myeloma Study) (Bortezomib Fig6)

This data shows the proportion of patients remaining after a specified time point in a study comparing Bortezomib and Dexamethasone treatments. Bortezomib had 310 patients initially, with 219, 138, 62, and 21 remaining at subsequent timepoints. Dexamethasone started with 292 patients, and had 201, 118, 59, and 20 remaining at the same timepoints. The study might have used a log-rank test to determine statistical significance.*

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Bortezomib-fign7 (Bortezomib Fig7)

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Bortezomib-fign8 (Bortezomib Fig8)

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Package Label-principal Display Panel-3.5 mg Per Vial (Container Label)

Description: This text contains information about a medication identified by the National Drug Code (NDC) 55150-337-02. The medication is a lyophilized vial containing 3.5 mg of bortezomib and 35 mg of mannitol. The usual dosage and storage instructions are provided, along with a reminder to refer to the package insert for detailed dosage information. The medication is intended for intravenous or subcutaneous use as a single-dose vial. The text also mentions the need to discard any unused portion of the medication.*

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Chemical Structure (Bortezomib Str)

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