Bortezomib Injection, Powder, Lyophilized, For Solution
Product Images NDC 83090-008

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Bortezomib (NDC 83090-008). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Sintetica 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.

FDA Label Image

Cartonlabel (Cartonlabel)

Packaging label for Bortezomib for Injection 3.5 mg/vial, a lyophilized powder for solution for intravenous or subcutaneous use. The single-dose vial contains 3.5 mg bortezomib and 35 mg mannitol. Labeler is Sintetica US LLC, with manufacturing by MSN Laboratories Private Limited, India. The label includes reconstitution instructions, storage conditions, and cytotoxic agent caution statements.*

FDA Label Image

Figure1 (Figure1)

A Kaplan-Meier survival curve chart showing the percentage of patients over time (months) for two treatment groups labeled B-MP and MP. The y-axis represents the percentage of patients, and the x-axis represents time in months up to 26 months. The chart includes numbers of patients at risk at various time points below the x-axis and a p-value noted at the bottom left corner.*

FDA Label Image

Figure2 (Figure2)

A Kaplan-Meier survival curve comparing two patient groups labeled B-MP and MP over time in months, showing percentage of patients on the y-axis. The chart includes p-value information (p < 0.05) and a table below listing the number of patients at risk for each group at different time points.*

FDA Label Image

Figure3 (Figure3)

A Kaplan-Meier survival curve chart comparing the proportion of patients over time (days) for Bortezomib and Dexamethasone treatments. The y-axis shows the proportion of patients, ranging from 0 to 1, and the x-axis shows time up to 450 days. The chart includes patient numbers remaining at various time points and a p-value indicating statistical significance from a log-rank test.*

FDA Label Image

Figure4 (Figure4)

A Kaplan-Meier survival curve graph comparing the proportion of patients who have not experienced failure over time (days) between Bortezomib and Dexamethasone treatment groups. The y-axis represents the proportion of patients without failure, and the x-axis shows days of follow-up, with patient counts at specific time points marked below the axis. A p-value from a log-rank test is displayed to indicate statistical comparison.*

FDA Label Image

Figure5 (Figure5)

A Kaplan-Meier survival curve chart depicting the percentage of patients over time in months for two treatment groups labeled BR-CAP and R-CHOP. The y-axis represents the percentage of patients, ranging from 0 to 100, and the x-axis shows time up to 60 months. The chart includes a p-value of less than 0.001 from a log-rank test, indicating a statistically significant difference between the groups. A table below the chart lists the number of subjects at risk at various time points for each group.*

FDA Label Image

Figure6 (Figure6)

A survival curve chart showing percentage of subjects alive over time in months from randomization, comparing two treatment groups: BR-CAP (solid line) and R-CHOP (dashed line). The chart includes numbers of subjects at risk at various time points and a hazard ratio with 95% confidence interval (0.66, 0.51 to 0.85).*

FDA Label Image

Stickerlabel (Stickerlabeliv)

Label for Bortezomib for Injection indicating intravenous use only. It details adding 3.5 mL of 0.9% sodium chloride to make a 1 mg/mL final concentration. Instructions include placing stickers on the vial and syringe labeled Intravenous Bortezomib. The label references package insert section 2 for full instructions and shows the labeler Sintetica US LLC.*

FDA Label Image

Stickerlabel (Stickerlabelsc)

Label for Bortezomib injection, lyophilized powder for solution, highlighting subcutaneous administration. It shows instructions for dilution with 0.9% sodium chloride, specifying to add 1.4 mL to achieve a final concentration of 2.5 mg/mL. It includes prompts to place stickers on vial and syringe, and references the package insert for full instructions. Manufacturer is Sintetica US LLC.*

FDA Label Image

Chemical Structure (Structure)

Chemical structure of Bortezomib, showing its molecular connections and arrangement of key functional groups including boronic acid, amide bonds, and aromatic rings.*

FDA Label Image

Viallabel (Viallabel)

Label for Bortezomib 3.5 mg per vial injection powder, lyophilized for solution, indicated for intravenous and subcutaneous use. The single-dose vial label indicates it is cytotoxic and unused portions should be discarded. It is manufactured by MSN Laboratories Private Limited and distributed by Sintetica US LLC in Princeton, NJ. Storage instructions specify 25°C with permitted excursions and protection from light.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.