Gemcitabine Injection, Powder, Lyophilized, For Solution
Product Images NDC 63323-102
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Product Visual Gallery
This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 63323-102). 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.
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Median Progression Free Survival:
Gemcitabine/Carboplatin combination therapy resulted in a median progression-free survival of 8.6 months, while Carboplatin alone had a median progression-free survival of 5.8 months. The Log rank p-value was calculated to be 0.0038. Data for this comparison was obtained from 178 patients for both Gemcitabine/Carboplatin and Carboplatin alone.*
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The text provides information on the progression-free probability and median time to documented disease progression for two different treatments - Gemcitabine/Paclitaxel and Paclitaxel. The progression-free probability is shown over time intervals, and the median time to documented disease progression is listed as 5.2 months for Gemcitabine/Paclitaxel and 2.9 months for Paclitaxel. It also includes a Log rank p-value of less than 0.0001, indicating a statistically significant difference between the two treatments in terms of disease progression.*
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This text provides survival probabilities for two different treatments: Gem/Cis and Cis. It includes information on the survival time in months for each treatment group, as well as the statistical analysis results (Logrank and Wilcoxon) for comparison. The data presented is related to survival time in months for patients receiving Gem/Cis and Cisplatin.*
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This text provides data on the fraction of patients surviving over time while being treated with Gemcitabine and 5-FU. The graph indicates survival time in months, with several time points (4, 8, 12, 16, and 20 months). It seems to be a chart or graph showing the survival rates of patients undergoing treatment with Gemcitabine and 5-FU over different time intervals.*
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This text appears to be a label for Gemcitabine injection medication. Gemcitabine is used as a cytotoxic agent for intravenous use only. The instructions indicate that to reconstitute the medication, one should mix it with a specific volume of 0.9% Sodium Chloride Injection. The storage conditions and handling precautions are also mentioned in the text. The manufacturer's contact information is provided for product inquiries. It is important to follow the dosage instructions provided in the accompanying package insert.*
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This description provides information about Gemcitabine injection, including its composition, dosage instructions, storage recommendations, and cautionary notes. It advises on the reconstitution process, administration, and the importance of discarding unused portions. The text also emphasizes the cytotoxic nature of Gemcitabine and recommends careful handling to avoid exposure. Additionally, it includes details such as the manufacturer's contact information, NDC number, and expiry date. It emphasizes that refrigeration is not recommended and highlights that the product should be used intravenously after proper dilution.*
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* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.