Macitentan Tablet, Film Coated
Product Images NDC 70710-1166
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Product Visual Gallery
This gallery contains 6 technical images submitted to the FDA as part of the official labeling for Macitentan (NDC 70710-1166). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Zydus Pharmaceuticals Usa 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 is a statistical description comparing the event-free survival rates of patients receiving Macitentan 10 mg versus Placebo. The Kaplan-Meier analysis showed that Macitentan had a higher event-free rate (318% vs. Placebo) with a Hazard Ratio of 0.547. The 95% Confidence Interval for Hazard Ratio was between 0.392 and 0.762. The Logrank p-value was found to be less than 0.001, indicating statistical significance. The data also includes the number of patients at risk over the months from treatment start for both Macitentan (242 at start, decreasing over time) and Placebo (250 at start, also decreasing over time).*
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This text appears to be a tabular representation of hazard ratios related to various characteristics in a study, such as overall treatment effect, age, sex, race, PAH etiology, concomitant PAH therapy, WHO FC at baseline, geographic region, and walk test baseline. It includes data points such as hazard ratios, EolNo, EpiNp, and confidence intervals. The table also shows a comparison between treatment groups (Mastertan and Pacobo) based on different parameters. Additionally, it mentions the number of patients in each group under specific conditions like age and WHO FC at baseline.*
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This text seems to contain information related to a clinical trial or medical study comparing Macitentan 10 mg with a placebo. The data includes percentages, hazard ratio (0.500), confidence intervals, and the number of participants at risk over various months from treatment start. It appears to provide insights into the effectiveness and outcomes of the treatment.*
Label (A5723ac2 5bfa 4270 9268 6a6533a841f7 06)
Each film-coated tablet contains 10 mg of macitentan. The usual dosage is one 10 mg tablet per day. The tablets should be stored at a temperature between 20°C and 25°C (68°F to 77°F) with permissible excursions between 15°C and 30°C (59°F and 86°F). This medication should be kept out of reach of children. There is a child-resistant packaging. The pharmacist should dispense the Medication Guide provided separately to each patient. For more information, visit the website wi2ydususa.com/medguides or call 1-877-993-8779. The package contains 30 tablets and is for prescription-only use. The medication is distributed by Zydus Pharmaceuticals (USA) Inc. located in Pennington, NJ 08534.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.