Grafapex Injection, Powder, Lyophilized, For Solution
Product Images NDC 59137-365

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Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Grafapex (NDC 59137-365). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Medexus Pharma, 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.

FDA Label Image

Treosulfan Chemical Structure (Chemical Structure)

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Figure 1 (Figure 1)

Figure 1 (Figure 1)
This is a statistical analysis related to the comparison of Busulfan and Treosulfan treatments in 290 and 280 patients, respectively. The text includes information on the number of events, patients censored, hazard ratio, confidence interval, and a breakdown of patients at risk over time. The data analysis appears to be based on a Cox proportional hazards model stratified by donor type and risk group.*
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Figure 2 (Figure 2)

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Figure 3 (Figure 3)

Figure 3 (Figure 3)
This is a statistical report showing data on two drugs, Busulfan and Treosulfan, used in patients. The report includes the number of patients, events, and censored data for each drug, along with the hazard ratio. Additionally, a graph displays the patients at risk over time for each drug. The hazard ratio of 0.64 suggests a difference in outcomes between the two drugs. The analysis is based on a Cox proportional hazards model, which is stratified by donor type and risk group.*
FDA Label Image

Grafapex 1g Carton (Grafapex Carton 1g)

Grafapex 1g Carton (Grafapex Carton 1g)
This text provides information regarding the printing area for the drug "GRAFAPEX™ (treosulfan) for Injection." It includes the National Drug Code (NDC) numbers for the different variants of the product, storage instructions, manufacturer details, reconstitution guidelines, and a warning about the stability of the reconstituted solution. The drug is indicated for intravenous infusion and contains 1g of treosulfan per vial. Recommended storage temperature is 20°C to 25°C (68°F to 77°F), and the product is stable for 24 hours after reconstitution at controlled room temperature. Unused portions should be discarded.*
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Grafapex 5g Carton (Grafapex Carton 5g)

Grafapex 5g Carton (Grafapex Carton 5g)
This is a detailed product label for "GRAFAPEX™" (treosulfan) for Injection manufactured by Medexus Pharma, Inc. in Chicago, IL, USA. The medication is produced by Oncotec Pharma Produktion GmbH in Germany and is a product of Finland. It is important to store it at a temperature between 20°C to 25°C, and after reconstitution, it can be stored for 24 hours at room temperature. The drug is for intravenous infusion and is a hazardous substance requiring careful handling, with any unused portion to be discarded. Each vial contains 5 troosulfan. The dosage and usage instructions can be found in the Prescribing Information.*
FDA Label Image

Grafapex 1g Vial (Grafapex Vial 1g)

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Grafapex 5g Vial (Grafapex Vial 5g)

Grafapex 5g Vial (Grafapex Vial 5g)
This text is about a medication called GRAFAPEX™ used for intravenous infusion after reconstitution. It is a hazardous drug that comes in a single-dose vial, and any unused portion should be discarded. The recommended dosage can be found in the prescribing information. The medication should be stored at 20°C to 25°C and should not be used if the solution contains a precipitate. The manufacturer is Medexus Pharma, Inc. in Chicago, IL, and it is manufactured by Oncotec Pharma Produktion GmbH in Dessau-RoBlau, Germany.*

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