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Macitentan Tablet
Product Images NDC 13668-542
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Product Visual Gallery
This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 13668-542). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Torrent Pharmaceuticals Limited, 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
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This information is about drug interactions involving the medication Macitentan. It includes details on interacting drugs such as the active metabolite, Sildenafil, Cyclosporine-A, Ketoconazole, and Rifampin, along with specific recommendations on dose adjustments. For Sildenafil and the active metabolite, no dose adjustment is recommended, while for Cyclosporine-A and Ketoconazole, it is advised to avoid them when taking Macitentan alone.*
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This is a statistical representation of a clinical study comparing the event-free survival rates between patients treated with Macitentan Tablets 10 mg and those who received a placebo. The data includes the Hazard Ratio, 95% confidence interval, and a significant p-value indicating a notable difference in outcomes between the two groups over the treatment period. The Kaplan-Meier curve provides information on the number of patients at risk over months from the start of treatment for each group.*
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This description shows a comparison between patients taking Macitentan Tablets 10mg and those on a placebo, based on event-free survival rates using Kaplan-Meier analysis. The hazard ratio is 0.500 with a 97.5% confidence interval of (0.335, 0.747), indicating a lower risk for patients on Macitentan. The logrank p-value is <0.0001, suggesting a statistically significant difference between the two groups. The data is presented over months from treatment start, with the number at risk for each group provided at different time points.*
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This text provides information on tablets containing 10 mg of macitentan, with details on dosage and storage instructions. It also mentions batch and expiration information, along with serialization details. The tablets are associated with the NDC number 43668-542-30. Additionally, the text advises keeping the medication out of reach of children. Manufacturer information includes Torrepharmaeutical and batch details.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
