Darzalex Injection, Solution, Concentrate
Product Images NDC 57894-502

Product Visual Gallery

This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Darzalex (NDC 57894-502). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Janssen Biotech, 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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Figure 1 (Darzalex 01)

This is a table displaying the proportion of patients with multiple myeloma surviving without progression after treatment with a medication called D-Rd compared to a medication called Rd. The table includes data on the number of patients, the median time without disease progression, and the hazard ratio for D-Rd vs. Rd. The table includes a graph displaying the percentage of patients surviving without progression over time, measured in months.*

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Darzalex 01a

This appears to be a data table showing the proportion surviving and median overall survival for two different treatments (D-Rd and Rd) and their hazard ratio in relation to each other over a period of 72 months. The table also includes the number of participants (N) and the number of participants remaining at different time points.*

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Figure 2 (Darzalex 02)

This is a clinical trial result showing the median progression-free survival time in months and hazard ratio for patients treated with D-vmP versus VMP. The proportion of surviving patients without progression is also shown in a graph. The trial involved 350 patients and the hazard ratio was significant.*

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Principal Display Panel (100 mg/5 mL Vial Carton)

The text provided seems to contain statistical data related to a medical study, including the number of participants, survival rates, hazard ratio, and P-value. There is also a table that shows the number of participants still under observation at various time intervals. Without more context, it is not clear what the study is about or what the abbreviations used in the text stand for.*

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Darzalex 04

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Darzalex 05

This is a report on survival rates and progression-free intervals of a sample group that underwent treatment with Rd and DRd. The group had 29 individuals, and the study found a higher survival rate for those using DRd compared to those using Rd alone. The medians of progression-free intervals were 184 and 289 for DRd and Rd, respectively. The results suggest that DRd may be more effective in treating the subjects' condition. The data are presented in a graph showing survival rates over the course of the study.*

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Darzalex 06

This seems to be a medical report indicating the proportion of patients surviving without the progression of a certain condition (possibly cancer). The document includes statistical data such as median progression-free survival months, hazard ratios, and results of the treatment comparison (DVd vs Vd). The report also includes a chart displaying the proportion of patients surviving at different points in time. Certain characters and words are not readable due to errors.*

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Darzalex 07

This appears to be a data table showing results of a clinical trial that compared the efficacy of two treatments in terms of their progression-free survival. The two treatment options are labeled as Kd and D-Kd, with D-Kd showing a statistically significant improvement in median progression-free survival (NE 158) compared to Kd. The Hazard ratio (95% CI) of D-Kd vs. Kd is 0.63 (0.46-0.85), with a P-value of 0.00014. The table shows a time frame of 24 months for the study and the number of patients at risk at each time point for each treatment.*

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Darzalex 08

DARZALEX® is an injection containing daratumumab that is intended for intravenous infusion only. It comes in a single-dose vial of 100mg/5mL (20mg/mL) which should be diluted before use. Unused portions should be discarded. The product of South Korea is manufactured by Janssen Botech, Inc. The package insert provides storage information, advising that unopened vials should be stored in a refrigerator at a temperature of 2°C-4°C. The text also mentions a 9% Sodium Chloride solution to be used in conjunction with the product.*

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Darzalex 09

This is a labeled text of Darzalex medicine which is an injection for intravenous infusion only, used to treat multiple myeloma. Each single-dose vial contains 100mg/ml of daratumumab solution, which should be discarded if it or part of it remains unused. The product needs to be diluted before use and should be used immediately after dilution. The unopened product needs to be refrigerated, and the vial should be protected from light. A diluted product should not be stored for later use. The dosage and other important information is present in the prescribing information.*

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