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Macitentan Tablet, Film Coated
Product Images NDC 0480-0915
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 0480-0915). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Teva Pharmaceuticals, 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.
Product Images & Figures Index
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This text provides information on the interacting drugs and their effects when used together with macitentan active metabolite. The text includes the point estimate and 90% confidence interval for drugs like sildenafil, cyclosporine-A, ketoconazole, and rifampin when interacting with macitentan. It also shows the change relative to macitentan alone for each drug.*
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This is a study comparing the efficacy of Macitentan 10 mg versus a placebo in reducing risk for a particular condition. The hazard ratio between the two treatments is 0.547 with a 97.5% confidence interval of (0.392, 0.762). The Logrank p-value suggests a statistically significant difference between the two groups (p < .0001). The study spanned over 36 months, showing the number at risk for each group decreased over time.*
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This is a statistical summary presenting hazard ratios and confidence intervals for different factors affecting the overall treatment effect on PAH patients. The data is segmented by variables like age, sex, race, PAH etiology, congenital heart diseases, and geographical regions, among others. The hazard ratios are calculated for each category, along with percentages and confidence intervals. The text mentions baseline characteristics, primary endpoints, and various specific conditions related to PAH. Additionally, it includes details on patients excluded for being under 18 years old or having different functional classes at baseline.*
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This is a table providing results of a study comparing the effects of Macitentan 10 mg versus a Placebo. The results are displayed in terms of number of individuals at risk over different months from treatment start, along with hazard ratio, 97.5% confidence interval, and the logrank p-value. These metrics are helpful in understanding the effectiveness of Macitentan in comparison to the placebo in this study.*
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The text provides information about Macitentan tablets containing 10 mg and recommends a daily dosage. It also includes storage instructions and details about the manufacturer. Additionally, it mentions the need to keep the medication out of reach of children and instructs pharmacists to dispense the accompanying Medication Guide to each patient.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
