Avsola Injection, Powder, Lyophilized, For Solution
Product Images NDC 55513-670

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Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Avsola (NDC 55513-670). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Amgen, 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.

Product Images & Figures Index

FDA Label Image

Figure 1: Kaplan Meier Estimate Of The Proportion Of Patients Who Had Not Lost Response Through Week 54 (Avsola 01)

Figure 1: Kaplan Meier Estimate Of The Proportion Of Patients Who Had Not Lost Response Through Week 54 (Avsola 01)
The text appears to be a table or chart comparing the percentage of patients who did not lose response to different treatments. Infliimab at 10 mg/kg had a statistically significant difference compared to the placebo. However, the percentage for Infliimab at 5 mg/kg is not available or unclear. The table shows data for different study weeks and maintenance treatments.*
FDA Label Image

Figure 2: Life Table Estimates Of The Proportion Of Patients Who Had Not Lost Fistula Response Through Week 54 (Avsola 02)

Figure 2: Life Table Estimates Of The Proportion Of Patients Who Had Not Lost Fistula Response Through Week 54 (Avsola 02)
This appears to be a graph showing the percentage of patients who had not lost response to a treatment compared to a placebo maintenance. The study was conducted with infliximab at a dosage of 5mg/kg, and the results showed a significant difference compared to the placebo maintenance group. The graph displays the study week and the percentage of patients who had not lost response over time.*
FDA Label Image

Figure 3: Proportion Of Patients Achieving Asas 20 Response (Avsola 03)

Figure 3: Proportion Of Patients Achieving Asas 20 Response (Avsola 03)
This is a graph displaying the proportion of patients in percentage, with a range from 0 to 100 on the y-axis. There are two categories mentioned on the x-axis: placebo and Ifliximab 5mg/kg. However, there is not enough information to determine what the proportion of patients is referring to.*
FDA Label Image

Figure 4: Proportion Of Patients Achieving ≥75% Improvement In Pasi From Baseline Through Week 50; Patients Randomized At Week 14 (Avsola 04)

Figure 4: Proportion Of Patients Achieving ≥75% Improvement In Pasi From Baseline Through Week 50; Patients Randomized At Week 14 (Avsola 04)
FDA Label Image

Principal Display Panelndc 55513-670-01avsola™(infliximab-axxq)for Injection 100 mg/vialamgen®100 mg/vialfor Intravenous Infusion Onlysingle-dose Vial. Discard Unused Portion.contents: Each Carton Contains One 100 mg Avsola Single-dose Vial.attention: Dispense The Enclosed Medication Guide To Each Patientreconstitute And Dilute Before Intravenous Infusion. Infuse Over At Least 2 Hours With An In-line Filter.protect From Light.dosage: See Prescribing Information.rx Only (Avsola 05)

Principal Display Panelndc 55513-670-01avsola™(infliximab-axxq)for Injection 100 mg/vialamgen®100 mg/vialfor Intravenous Infusion Onlysingle-dose Vial. Discard Unused Portion.contents: Each Carton Contains One 100 mg Avsola Single-dose Vial.attention: Dispense The Enclosed Medication Guide To Each Patientreconstitute And Dilute Before Intravenous Infusion. Infuse Over At Least 2 Hours With An In-line Filter.protect From Light.dosage: See Prescribing Information.rx Only (Avsola 05)
AVSOLA is a medication given through intravenous infusion. It is available in 100mg/vial single dose vials, and any unused portion should be discarded. The medication should be reconstituted and diluted prior to infusion and infused over a minimum of 2 hours with an in-line filter. The prescribing information should be consulted for proper dosage. Patients should be given the enclosed medication guide. AVSOLA is NDC 55513-670-01.*

* 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.