Avgemsi
Product Images NDC 83831-122

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Avgemsi (NDC 83831-122). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Avyxa Pharma, 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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Figure 1 (Figure01)

A Kaplan-Meier curve chart comparing median progression-free survival between Gemcitabine/Carboplatin combination therapy and Carboplatin alone. The x-axis shows progression-free survival in months, and the y-axis shows progression-free probability. The chart indicates longer progression-free survival for Gemcitabine/Carboplatin with a p-value of 0.0038.*

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Figure 2 (Figure02)

A Kaplan-Meier survival curve chart comparing median time to documented disease progression between Gemcitabine/Paclitaxel combination therapy and Paclitaxel alone. The x-axis represents time in months, and the y-axis shows progression-free probability, with curves for each treatment group and relevant median times indicated.*

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Figure 3 (Figure03)

A Kaplan-Meier survival curve comparing survival probability over time (in months) between two treatment groups: Cisplatin (N=262) and Gemcitabine/Cisplatin (N=260). The chart includes median survival times (9.0 months for Gemcitabine/Cisplatin, 7.6 months for Cisplatin), 1-year survival rates (39% vs. 28%), and significance test statistics (Logrank p=0.008, Wilcoxon p=0.018).*

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Figure 4 (Figure04)

A survival curve chart comparing the fraction surviving over survival time in months for two treatments: 5-FU and Gemcitabine. The y-axis represents the fraction surviving from 0.0 to 1.0, and the x-axis represents survival time in months from 0 to 20.*

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Image Description (Image0005)

Label for AVGEMSI (gemcitabine) Injection 2 g/52.6 mL (38 mg/mL) for intravenous infusion after dilution. The label includes a warning that it is a hazardous drug and specifies it is for Rx only. Presented as one multiple-dose vial and manufactured by Avyxa Pharma, LLC, with storage and dosage instructions printed on the label.*

FDA Label Image

Image Description (Image004)

Packaging label for AVGEMSI (gemcitabine) Injection 1 g/26.3 mL (38 mg/mL) by Avyxa Pharma, LLC. The label states it is for intravenous infusion after dilution, labeled as a hazardous drug, and includes storage instructions for unopened multiple-dose vials and partially used vials. The label features dosage information, manufacturer details, and multiple barcodes.*

FDA Label Image

Image Description (Image006)

Packaging label for AVGEMSI (gemcitabine) Injection 2 g/52.6 mL (38 mg/mL) by Avyxa Pharma, LLC. The label indicates it is a hazardous drug for intravenous infusion after dilution, supplied as one multiple-dose vial. Storage instructions specify refrigeration at 2°C to 8°C with warnings not to freeze and guidance for storing partially used vials up to 14 days. The label includes barcodes and manufacturing details.*

FDA Label Image

Image Description (Image01)

Label for AVGEMSI (gemcitabine) Injection 38 mg/mL, presented as 200 mg/5.26 mL in one multiple-dose vial. The label states it is for intravenous infusion after dilution, with a warning for hazardous drug handling. It includes storage instructions and manufacturer information for Avyxa Pharma, LLC, New Jersey, USA.*

FDA Label Image

Image Description (Image02)

Packaging label for AVGEMSI (gemcitabine) Injection, 200 mg/5.26 mL (38 mg/mL) by Avyxa Pharma, LLC. The label states the product is for intravenous infusion after dilution, contains one multiple-dose vial, and includes storage instructions and a warning about its hazardous nature. Manufactured in Switzerland.*

FDA Label Image

Image Description (Image03)

Label for AVGEMSI (gemcitabine) Injection, 1 g/26.3 mL (38 mg/mL) strength. This hazardous drug is for intravenous infusion after dilution and comes in one multiple-dose vial. The label includes storage and dosage instructions and shows Avyxa Pharma, LLC as the manufacturer. It also features a barcode and spaces for lot number, expiration date, and date.*

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Logo (Logo)

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Structure (Structure001)

Chemical structure of the active ingredient in AVGEMSI 38 mg/mL, showing a fluorinated nucleoside analog with hydroxyl groups and a pyrimidine base.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.