Structure (Image 01)
Gemcitabine Injection, Solution
Product Images NDC 67457-617
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 67457-617). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Mylan Institutional 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.
Figure 1 (Image 02)
This is a figure showing Kaplan-Meier curves for progression-free survival in a study comparing gemcitabine/carboplatin to carboplatin alone. The median progression-free survival time was 8.6 months for gemcitabine/carboplatin and 5.8 months for carboplatin alone. The log rank test showed a statistically significant difference (p=0.0038) favoring gemcitabine/carboplatin. The x-axis shows progression-free survival time (months) and the y-axis shows the proportion of patients without progression.*
Figure 2 (Image 03)
The image shows a graph with Kaplan-Meier Curves representing the time it takes for documented disease progression in Study 2. The median time for documented disease progression is 5.2 months for Gemcitabine/Paclitaxel and 2.9 months for Paclitaxel alone. The graph also includes information on the number of participants in each group and the log rank p-value.*
Figure 3 (Image 04)
The image is a graph showing Kaplan-Meier curves for overall survival in Study 3. It compares the survival probability of Gemcitabine/Cisplatin (N=260) and Cisplatin (N=262) over time. The median survival with Gem/Cis was 9.0 months and 1-year survival was 39%, while with Cis alone it was 7.6 months and 1-year survival was 28%. The test statistic Logrank was 0.008 and Wilcoxon was 0.018.*
Figure 4 (Image 05)
This appears to be a graph depicting the Kaplan-Meier survival curves for overall survival in Study 5. The x-axis shows the survival time (in months) and the y-axis shows the fraction surviving. The figure includes two lines, one for the treatment with gemcitabine and another whose label is not available in the text provided.*
Carton 200 mg (Image 06)
Gemcitabine Injection is a single-dose vial containing 200 mg of gemcitabine hydrochloride, USP, which is equivalent to 227.5 mg of gemcitabine, along with pH-adjusting agents and water for injection. It is intended for intravenous infusion only and is a cytotoxic agent that requires careful handling to avoid inhalation and skin contact. Dosage and administration information should be obtained from the package insert. Gemcitabine should be stored between 2 to 8°C and should not be frozen. The vial must be diluted before use and any unused portion should be discarded. The product is manufactured by Mylan Institutional LLC in India.*
Carton 1 G (Image 07)
Carton 2 G (Image 08)
Gemcitabine Injection is a cytotoxic drug that should be handled with caution. Each vial contains 2 g gemcitabine and Water for Injection. Hydrochloric acid or sodium hydroxide may be added to adjust pH. It must be diluted before it is used for intravenous infusion only. It should not be frozen and stored between 2°C to 8°C. Further details regarding dosage and administration can be found in the package insert. This Mylan product is manufactured in India and distributed in the U.S. by Mylan Institutional LLC. The single-dose vial has a volume of 52.6 mL and contains 38 mg/mL of gemcitabine. Lot XKXXXXX with NDC 67457-618-10.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
