Label Image (Lbl500903617)
Pradaxa
Product Images NDC 50090-3617
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Pradaxa (NDC 50090-3617). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by A-s Medication Solutions, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Figure 1 (Pradaxa 01)
This is a clinical trial report that compares the safety of Pradaxa 150 with warfarin for the prevention of major bleeding events in patients with stroke or cardiovascular risk factors. The trial involved over 18,000 patients who were divided into subgroups based on age, gender, weight, medical history, and other factors. The report includes statistical analyses, such as hazard ratios, for each subgroup to determine the efficacy of the treatments.*
Chemical Structure (Pradaxa 02)
Figure 2 (Pradaxa 03)
This appears to be a chart or graph displaying the time course of a test called aPTT (activated partial thromboplastin time) with measurements in seconds. There are two dosages of a medication called PRADAXA listed, 150 mg BID (twice a day) for patients with a creatinine clearance > 30 mL/min and 75 mg BID for patients with a creatinine clearance € 30 mL/min. However, the chart is incomplete and it is unclear what the percentages indicate.*
Figure 3.1 (Pradaxa 04)
Figure 3.2 (Pradaxa 05)
This appears to be a table or chart without any clear headings. Without additional context or information, it is not possible to provide a useful description.*
Figure 4 (Pradaxa 06)
This appears to be a graph or chart, but it cannot be properly read without additional context. The text includes medication names and dosages, as well as a time period, but the purpose or meaning of the chart is not available.*
Figure 5 (Pradaxa 07)
This is a table of patient characteristics and their subgroups in a study comparing Pradaxa 150 to Warfarin for stroke. It provides information on patients' VKA use, age, gender, weight, history of stroke/TIA, diabetes at baseline, CHADS2 score, region, and ASA use at baseline. It also includes data on the number of patients in each subgroup and their respective total count. There are further columns and tables providing hazard ratios and confidence intervals for PRADAXA 150 vs. Warfarin.*
Figure (Pradaxa 08)
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
