Gemcitabine Injection, Solution
Product Images NDC 71288-117

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Gemcitabine (NDC 71288-117). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Meitheal Pharmaceuticals 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.

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Structural Formula (Gem0g 0004 01)

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Figure 1 (Gem0g 0004 02)

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Figure 2 (Gem0g 0004 03)

This text describes Kaplan-Meier curves for time to documented disease progression in Study 2 comparing Gemcitabine/Paclitaxel and Paclitaxel treatments. The median time to documented disease progression was 52 months for Gemcitabine/Paclitaxel and 2.8 months for Paclitaxel. The log rank p-value was less than 0.0001, indicating a significant difference in disease progression between the two treatments.*

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Figure 3 (Gem0g 0004 04)

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Figure 4 (Gem0g 0004 05)

This data appears to be a survival curve showing the fraction of individuals surviving over different timepoints (in months) after treatment with Gemcitabine and 5FU. The x-axis shows the survival time in months, while the y-axis represents the fraction surviving. This type of plot is commonly used in medical and scientific research to visualize and analyze survival data.*

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Principal Display Panel – Gemcitabine Injection 200 mg Vial Label (Gem0g 0004 Viz 06)

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Principal Display Panel – Gemcitabine Injection 200 mg Carton (Gem0g 0004 Viz 07)

This is a product description for Gemcitabine injection. It is a sterile and non-pyrogenic solution for intravenous infusion. The medication comes in a single-dose vial containing 200 mg of Gemcitabine, which needs to be diluted before use. It should be stored refrigerated between 2°C and 8°C (36°F and 46°F) and should not be frozen. The container closure does not contain natural rubber latex. It is imperative to follow the dosing and administration instructions provided in the package insert due to its potential for toxicity. The manufacturer is Meitheal Pharmaceuticals located in Chicago, USA.*

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Principal Display Panel – Gemcitabine Injection 1 Gram Vial Label (Gem0g 0004 Viz 08)

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Principal Display Panel – Gemcitabine Injection 1 Gram Carton (Gem0g 0004 Viz 09)

This is a pharmaceutical label providing information about Gemcitabine Injection, which must be diluted before use and stored refrigerated between 2°C and 8°C. It is indicated for intravenous infusion only and contains a caution that it is a cytotoxic agent. The label also includes details such as the dose volume, single-dose vial information, and the trademark name Novaplus.*

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Principal Display Panel – Gemcitabine Injection 2 Gram Vial Label (Gem0g 0004 Viz 10)

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Principal Display Panel – Gemcitabine Injection 2 Gram Carton (Gem0g 0004 Viz 11)

This text provides information about Gemcitabine Injection, which comes in a 2-gram per 52.6 mL concentration for intravenous infusion only. It must be diluted before use and stored refrigerated between 2°C and 8°C (36°F and 46°F). The product is labeled as a Cytotoxic Agent and the single-dose vial is referenced as 13526 L. The text also mentions novaplus™ as part of the product labeling.*

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