Mitomycin-spl-structure (Mit08 0000 01)
Mitomycin Injection, Powder, Lyophilized, For Solution
Product Images NDC 65219-568
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Product Visual Gallery
This gallery contains 4 technical images submitted to the FDA as part of the official labeling for Mitomycin (NDC 65219-568). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Fresenius Kabi Usa, 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.
Fresenius Kabi Logo (Mit08 0000 02)
Principal Display Panel – Mitomycin For Injection, Usp 40 mg/vial – Carton (Mit08 0000 03)
Mitomycin for Injection is a cytotoxic agent that is administered intravenously to avoid tissue damage. It comes in a single-dose vial that contains 40 mg of Mitomycin and 80 mg of Mannitol. Sterile water for injection must be added to the vial to create the solution. The reconstituted solution must be stored in the refrigerator between 2°C to 8°C and should be discarded after 14 days. The dosage is indicated in the package insert, which contains full prescribing information.*
Principal Display Panel – Mitomycin For Injection, Usp 40 mg/vial – Vial Label (Mit08 0000 04)
This is a prescription-only vial containing 40mg of mitomycin and 80mg of mannitol. It should be diluted with 80mL of sterile water for injection, USP and shaken to dissolve. Each mL of reconstituted solution will contain 0.5mg of mitomycin and have a pH between 6.0 and 8.0. This is a cytotoxic agent that must be administered intravenously to avoid tissue damage. It should be stored in the carton between 15°C and 30°C and protected from light. The dry powder should be stored between 2°C and 8°C, while the reconstituted solution should be stored under refrigeration and discarded after 14 days.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
