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Sacubitril And Valsartan Tablet, Film Coated
Product Images NDC 43598-643
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Product Visual Gallery
This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Sacubitril And Valsartan (NDC 43598-643). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Dr. Reddy's Laboratories 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.
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Population Description: The text provides information on the geometric mean ratio and 90% CI for various factors including AUC Crnax, renal impairment levels (mild, moderate, severe), hepatic impairment levels (mild, moderate), age groups (≥65 years, 18-45 years), gender (male/female), ethnicity (Asian - Japanese and Chinese/Caucasian, Black/Caucasian), and changes relative to reference values. This data can be valuable for understanding the impact of these factors on specific outcomes.*
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The text describes a comparison study called PARADIGM-HF, where patients were treated with either Enalapril or Sacubitril and Valsartan. The study evaluated the time to first occurrence of cardiovascular death or heart failure hospitalizations, time to occurrence of cardiovascular death, and time to occurrence of heart failure hospitalizations. The results of the study show significant differences between the two treatments, with p<0.0001 indicating a strong statistical significance favoring Sacubitril and Valsartan over Enalapril in reducing cardiovascular events.*
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The text provides data on various subgroups of the population based on age, gender, weight, race, region, medical conditions like diabetes and hypertension, prior medication usage, time since diagnosis of heart failure, cause of heart failure, and treatment with medications like Sacubitril and Valsartan and Enalapril. It also includes information on hazard ratios comparing the effectiveness of Sacubitril and Valsartan versus Enalapril. This data can be used for analysis and evaluation in the context of heart failure treatment.*
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This text provides information on hazard ratios for different treatments (Sacubitril and Valsartan vs. enalapril, and Sacubitril and Valsartan vs. valsartan) in clinical trials such as PARADIGM-HF and PARAGON-HF. It also includes data on left ventricular ejection fraction at screening in percentage. The text shows numeric values and headings for these parameters, which could be used for further analysis or comparisons in a medical context.*
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* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
