Bortezomib Injection
Product Images NDC 63759-3032

View Photos of Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Bortezomib (NDC 63759-3032). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Shilpa Medicare Limited, 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

Image (71ebcbb5 31e2 4394 8a38 D833fd3c733a 01)

FDA Label Image

Image (71ebcbb5 31e2 4394 8a38 D833fd3c733a 02)

Image (71ebcbb5 31e2 4394 8a38 D833fd3c733a 02)
This data likely pertains to a medical study or clinical trial, indicating the percentage of patients at specific time points along with the number of patients at risk in two different groups (B-MP and MP). The information includes a statistical significance value (p=0.000002) and shows a survival curve over a period of 26 months. The p-value from log-rank test suggests a comparison between the two patient groups. Time in months is plotted on the x-axis, with decreasing numbers of patients at risk shown at each subsequent time point.*
FDA Label Image

Image (71ebcbb5 31e2 4394 8a38 D833fd3c733a 03)

Image (71ebcbb5 31e2 4394 8a38 D833fd3c733a 03)
This data provides information on the percentage of patients at different timepoints during a medical study. It includes the number of patients at risk over several months for two different treatment groups: B-MP and MP. The last section mentions a log-rank test for statistical analysis.*
FDA Label Image

Image (71ebcbb5 31e2 4394 8a38 D833fd3c733a 04)

Image (71ebcbb5 31e2 4394 8a38 D833fd3c733a 04)
This text provides data on the proportions of patients remaining after specific time points for two treatments, Bortezomib and Dexamethasone. The table lists the number of patients at different time intervals (30, 60, 120, etc.) and indicates the p-value from a log-rank test. This information can be used to evaluate the effectiveness and outcomes of these treatments over time.*
FDA Label Image

Image (71ebcbb5 31e2 4394 8a38 D833fd3c733a 05)

Image (71ebcbb5 31e2 4394 8a38 D833fd3c733a 05)
This text provides information on the proportion of patients over time receiving Bortezomib and Dexamethasone, with respective patient counts at different time points. It also mentions a p-value derived from a log-rank test analysis. This data appears to be a part of a study or analysis evaluating the effectiveness or outcomes of these treatments on a patient population.*
FDA Label Image

Figure 5: Progression-free Survival Vcr-cap Vs R-chop (previously Untreated Mantle Cell Lymphoma Study) (71ebcbb5 31e2 4394 8a38 D833fd3c733a 06)

Figure 5: Progression-free Survival Vcr-cap Vs R-chop (previously Untreated Mantle Cell Lymphoma Study) (71ebcbb5 31e2 4394 8a38 D833fd3c733a 06)
This appears to be a list of patient numbers in a medical context, possibly related to the R-CHOP treatment. It includes various numbers such as 243, 244, 187, 181, 146, and 186. The context or details of the patients are not provided in this text.*
FDA Label Image

Figure 6: Overall Survival Vcr-cap Vs R-chop (previously Untreated Mantle Cell Lymphoma Study) (71ebcbb5 31e2 4394 8a38 D833fd3c733a 07)

Figure 6: Overall Survival Vcr-cap Vs R-chop (previously Untreated Mantle Cell Lymphoma Study) (71ebcbb5 31e2 4394 8a38 D833fd3c733a 07)
This text provides survival information about two different treatment groups: BR-CAP and R-CHOP, with the number of subjects alive being shown in a table over a 96-month period. The Hazard Ratio is also provided as 0.66 with a 95% confidence interval between 0.51 and 0.85.*
FDA Label Image

Bortezomib Injection 3.5 mg/1.4 mL (71ebcbb5 31e2 4394 8a38 D833fd3c733a 08)

Bortezomib Injection 3.5 mg/1.4 mL (71ebcbb5 31e2 4394 8a38 D833fd3c733a 08)
This text is a description of a medication called Bortezomib Injection. It contains 2.5 mg of bortezomib, 25 mg of mannitol, sodium chloride for isotonicity, and water for injection per mL. The dosage is specified in the prescribing information. It is intended for intravenous or subcutaneous use and comes in single-dose vials. The medication should be stored refrigerated at 2°C to 8°C in the original package to protect it from light. The text also includes a warning about it being a hazardous drug. The product is manufactured by Amneal Oncology Private Limited in India for Shilpa Medicare Limited.*
FDA Label Image

Bortezomib Injection 3.5 mg/1.4 mL (71ebcbb5 31e2 4394 8a38 D833fd3c733a 09)

Bortezomib Injection 3.5 mg/1.4 mL (71ebcbb5 31e2 4394 8a38 D833fd3c733a 09)
This is a description of Bortezomib, an injection used for intravenous or subcutaneous administration. It comes in a single-dose vial and contains 3.5mg/1.4mL (2.5 mg/mL). The medication should be stored refrigerated at 2°C to 8°C and protected from light. Each mL of the injection contains 2.5 mg of bortezomib, 25 mg of mannitol, sodium chloride for isotonicity, and water for injection. The package includes information on dilution and dosage, highlighting that no further dilution is required for intravenous injection. The drug is marked as a hazardous substance and should be used as per prescribing information. The product details also mention the manufacturer as Amneal Oncology Private Limited in Telangana, India.*
FDA Label Image

Bortezomib Injection 3.5 mg/0.2ml (71ebcbb5 31e2 4394 8a38 D833fd3c733a 10)

Bortezomib Injection 3.5 mg/0.2ml (71ebcbb5 31e2 4394 8a38 D833fd3c733a 10)
This text provides dilution information for preparing a final concentration of 1 mg/mL using 2.1 mL of 0.9% Sodium Chloride Injection. No further details are given.*
FDA Label Image

Bortezomib Injection 3.5 mg/1.4 mL (71ebcbb5 31e2 4394 8a38 D833fd3c733a 11)

Bortezomib Injection 3.5 mg/1.4 mL (71ebcbb5 31e2 4394 8a38 D833fd3c733a 11)
This is a prescription for Bortezomib Injection, which is to be administered via intravenous injection using 0.9% Sodium Chloride Injection. It is important to follow the full instructions provided in the Prescribing Information (Section 2) before administering the medication. No further dilution is required.*

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