Figure (Hep11 0001 01)
Hepzato Kit
Product Images NDC 75833-601
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 50 technical images submitted to the FDA as part of the official labeling for Hepzato Kit (NDC 75833-601). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Delcath Systems, 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.
Product Images & Figures Index
Figure (Hep11 0001 02)
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Figure (Hep11 0001 18)
The available text indicates the presence of three separate components or sections related to filtration. The first section is labeled "OUTFLOW" and the second section is labeled "INFLOW." Both of these sections are followed by multiple blank lines. The third component is labeled "FILTER BYPASS." Overall, it appears to describe a filtration system with different pathways for inflow and outflow, as well as an option for bypassing the filter.*
Figure (Hep11 0001 19)
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Principal Display Panel (Kit Label)
HEPZATO® KIT is a specialized medical kit that contains melphalan for injection and a hepatic delivery system (HDS). The kit includes a double balloon catheter, vials of melphalan, and a diluent. The melphalan is used for intra-arterial infusion, specifically for hepatic delivery.
The kit is packaged with 5 vials of melphalan and sterile diluent. Each vial contains freeze-dried melphalan, sodium citrate, propylene glycol, ethanol, and water for injection. The diluent and melphalan must be reconstituted and further diluted with 0.9% Sodium Chloride Injection USP.
The kit is intended for single-dose use and should be used according to the enclosed prescribing information. It is important to follow the provided instructions for reconstitution and administration.
The kit should be stored at a controlled room temperature between 20°C to 25°C (68°F to 77°F) and protected from light. The kit contains a double balloon catheter that contains natural rubber latex, which may cause allergic reactions.
The kit is manufactured and distributed by Delcath Systems, Inc. in Queensbury, NY. The lot number and expiration date are provided on the packaging.
Please consult the HEPZATO KIT™ Instructions for Use for more information on how to properly use the kit.*
Principal Display Panel – 50 mg Vial Label (Hep11 0001 48)
Not available.*
Principal Display Panel – 10 mL Diluent Vial Label (Hep11 0001 49)
Principal Display Panel (0.9 g/250 mL Container Label)
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
