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

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.

FDA Label Image

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)

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)

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)

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)

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.*

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