Renflexis
Product Images NDC 0006-4305

Product Visual Gallery

This gallery contains 5 technical images submitted to the FDA as part of the official labeling for Renflexis (NDC 0006-4305). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Merck Sharp & Dohme 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.

FDA Label Image

Figure 1 (Renflexis 01)

A line graph showing the percentage of patients who had not lost response over a 54-week study period. The graph compares three groups: placebo maintenance, 5 mg/kg infliximab maintenance, and 10 mg/kg infliximab maintenance. The y-axis represents the percentage of patients who had not lost response, and the x-axis shows study weeks from 0 to 54. Statistical significance for infliximab groups compared to placebo is indicated with p-values.*

FDA Label Image

Figure 2 (Renflexis 02)

A line graph showing the percentage of patients who had not lost response over 54 study weeks comparing placebo maintenance and 5 mg/kg infliximab maintenance. The y-axis represents the percentage of patients, and the x-axis represents study weeks. Two lines indicate that patients on 5 mg/kg infliximab maintenance had a higher percentage of not losing response compared to placebo maintenance throughout the study.*

FDA Label Image

Figure 3 (Renflexis 03)

A line graph comparing the proportion of patients (%) over 24 weeks between two groups: Placebo and Infliximab 5 mg/kg. The x-axis represents time in weeks, and the y-axis represents the proportion of patients. The Infliximab group shows a higher proportion of patients throughout the study, with statistically significant differences indicated by asterisks (P < 0.001).*

FDA Label Image

Figure 4 (Renflexis 04)

A line graph showing the percent of patients over 50 weeks, comparing four groups receiving infliximab at different doses and intervals: 3 mg/kg every 8 weeks, 3 mg/kg as needed (PRN), 5 mg/kg every 8 weeks, and 5 mg/kg as needed (PRN). The y-axis represents percent of patients, and the x-axis represents weeks of treatment.*

FDA Label Image

Principal Display Panel (100 mg Vial Carton)

Packaging label for Renflexis (infliximab-abda) 100 mg/vial injection by Merck Sharp & Dohme LLC, manufactured by Samsung Bioepis Co., Ltd. The label indicates single-dose vial for intravenous infusion, with storage instructions and reconstitution information. The product is distributed in the USA and manufactured in the Republic of Korea, with no U.S. standard of potency.*

* 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.