Bortezomib Injection, Powder, Lyophilized, For Solution
Product Images NDC 70069-836

Product Visual Gallery

This gallery contains 13 technical images submitted to the FDA as part of the official labeling for Bortezomib (NDC 70069-836). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Somerset Therapeutics 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

Bortecarton (Bortecarton)

Packaging label for Bortezomib for Injection 3.5 mg/vial, a lyophilized powder for solution by Somerset Therapeutics LLC. The label indicates intravenous or subcutaneous use, with reconstitution information for both routes. It includes dosage and storage instructions, manufacturer details, and a barcode.*

FDA Label Image

Bortetraylabel (Bortetraylabel)

A dosing instruction panel for Bortezomib for Injection showing two methods: subcutaneous and intravenous. The subcutaneous section advises adding 1.4 mL of 0.9% sodium chloride to achieve a 2.5 mg/mL concentration. The intravenous section advises adding 3.5 mL of 0.9% sodium chloride to achieve a 1 mg/mL concentration. Both include notes to place stickers on the vial and syringe, with a reference to see the package insert for full instructions.*

FDA Label Image

Bortevialtray (Bortetvialray)

Label for Bortezomib for Injection 3.5 mg vial, a lyophilized powder for solution. It includes warnings to read reconstitution information, protect from light, notes it is a single dose vial, and instructs to discard unused portions. It specifies use for intravenous or subcutaneous administration and lists Somerset Therapeutics, LLC as the labeler.*

FDA Label Image

Borteviallabel (Borteviallabel)

Label for Bortezomib for Injection 3.5 mg per vial, a lyophilized powder for solution injection. The vial is for intravenous or subcutaneous use and is a single-dose vial. The label includes storage instructions, mentioning storage at 25°C with permitted excursions, and a caution that it is a cytotoxic agent. Manufactured for Somerset Therapeutics LLC, Somerset, NJ.*

FDA Label Image

Figure (Bortezomib 01)

A formula illustrating the calculation for the total volume of Bortezomib for Injection to be administered. It shows Bortezomib dose in mg per square meter multiplied by patient body surface area (BSA) divided by 1 mg/mL equals the total injection volume in milliliters.*

FDA Label Image

Figure (Bortezomib 02)

A formula illustrating the calculation of total Bortezomib injection volume to be administered. It shows dose (mg/m²) multiplied by patient body surface area (BSA in m²), divided by 2.5 mg/mL, equating to the total injection volume in milliliters.*

FDA Label Image

Chemical Structure (Bortezomib 03)

Chemical structure diagram of bortezomib, depicting its molecular arrangement including rings, bonds, and functional groups, consistent with the active ingredient in the product Bortezomib injection, powder, lyophilized.*

FDA Label Image

Figure 1 (Bortezomib 04)

A Kaplan-Meier survival curve chart showing the percentage of patients over time in months. It compares two groups: Vc-MP (red line) and MP (blue line), indicating a higher patient survival percentage over 24 months for the Vc-MP group. The chart includes a p-value from a log-rank test and the number of patients at risk at various time points for each group.*

FDA Label Image

Figure 2 (Bortezomib 05)

A Kaplan-Meier survival curve graph showing the percentage of patients over time (in months) for two groups: Vc-MP (red dashed line) and MP (solid blue line). The graph includes numbers at risk below the x-axis and indicates a p-value of less than 0.05 from a log-rank test, suggesting a statistically significant difference between the two groups.*

FDA Label Image

Figure 3 (Bortezomib 06)

A Kaplan-Meier survival curve comparing the proportion of patients over time (days) between Bortezomib and Dexamethasone treatments. The graph shows patient numbers at specific time points and a p-value indicating statistical analysis from a log-rank test. Bortezomib curve is higher, indicating a greater proportion of patients over time compared to Dexamethasone.*

FDA Label Image

Figure 4 (Bortezomib 07)

A survival curve chart comparing the proportion of patients over time (days) for Bortezomib versus Dexamethasone. The chart shows patient counts remaining at various time points with Bortezomib consistently higher. A p-value of less than 0.05 is noted from a log-rank test, indicating statistical analysis between groups.*

FDA Label Image

Bortezomib-08 (Bortezomib 08)

A Kaplan-Meier survival curve chart showing the percentage of patients over time in months for two treatment groups labeled VcR-CAP and R-CHOP. The chart includes a log rank test p-value less than 0.001, indicating statistical significance, and a table beneath showing the number of subjects at risk at several time points for both groups.*

FDA Label Image

Bortezomib-09 (Bortezomib 09)

A Kaplan-Meier survival curve chart showing the percentage of subjects alive over time (months from randomization) for two treatment groups: VcR-CAP (solid line) and R-CHOP (dashed line). The chart includes a hazard ratio with 95% confidence interval (0.66 [0.51, 0.85]) and a table of subjects at risk at various time points below the x-axis.*

* 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.