Dabigatran Etexilate Capsule
Product Images NDC 0378-0265

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Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Dabigatran Etexilate (NDC 0378-0265). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Mylan 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.

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Dabigatran Etexilate Mesylate (Image 01)

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Figure 1. Adjudicated Major Bleeding By Baseline Characteristics Including Hemorrhagic Stroke Treated Patients (Image 02)

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Figure 3.1. Effect Of P-gp Inhibitor Or Inducer (rifampicin) Drugs On Peak And Total Exposure To Dabigatran (cmax And Auc). Shown Are The Geometric Mean Ratios (ratio) And 90% Confidence Interval (90% Ci). The Perpetrator And Dabigatran Etexilate Dose And Dosing Frequency Are Given As Well As The Time Of Perpetrator Dosing In Relation To Dabigatran Etexilate Dose (time Difference) (Image 03)

Figure 3.1. Effect Of P-gp Inhibitor Or Inducer (rifampicin) Drugs On Peak And Total Exposure To Dabigatran (cmax And Auc). Shown Are The Geometric Mean Ratios (ratio) And 90% Confidence Interval (90% Ci). The Perpetrator And Dabigatran Etexilate Dose And Dosing Frequency Are Given As Well As The Time Of Perpetrator Dosing In Relation To Dabigatran Etexilate Dose (time Difference) (Image 03)
This document appears to contain information related to the interaction of various drugs with P-glycoprotein inhibitors and inducers. It lists different drug names, doses, and metrics such as AUC (area under the curve) and Cmax (maximum concentration). The text also mentions fold changes in pharmacokinetics (PK) and presents confidence intervals (CI). The data provided seems to be comparing the effects of different drugs on PK parameters when interacting with P-glycoprotein inhibitors or inducers. It emphasizes the relative changes compared to a reference value.*
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Figure 3.2: Effect Of Non-p-gp Inhibitor Or Inducer, Other Drugs, On Peak And Total Exposure To Dabigatran (cmax And Auc). Shown Are The Geometric Mean Ratios (ratio) And 90% Confidence Interval (90% Ci). The Perpetrator And Dabigatran Etexilate Dose And Dosing Frequency Are Given As Well As The Time Of Perpetrator Dosing In Relation To Dabigatran Etexilate Dose (time Difference) (Image 04)

Figure 3.2: Effect Of Non-p-gp Inhibitor Or Inducer, Other Drugs, On Peak And Total Exposure To Dabigatran (cmax And Auc). Shown Are The Geometric Mean Ratios (ratio) And 90% Confidence Interval (90% Ci). The Perpetrator And Dabigatran Etexilate Dose And Dosing Frequency Are Given As Well As The Time Of Perpetrator Dosing In Relation To Dabigatran Etexilate Dose (time Difference) (Image 04)
This is a list of different drugs with their corresponding dosages and frequencies, as well as fold change and 90% confidence intervals. The text mentions various medications such as Atorvastatin, Clopidogrel, Diclofenac, Enoxaparin, Pantoprazole, and Ranitidine. Dosages and frequencies vary for each drug. The text may be part of a study or research on drug interactions or efficacy.*
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Figure 2. Average Time Course For Effects Of Dabigatran On Aptt, Following Approved Dabigatran Etexilate Capsules Dosing Regimens In Adult Patients With Various Degrees Of Renal Impairment (Image 05)

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Figure 5. Stroke And Systemic Embolism Hazard Ratios By Baseline Characteristics (Image 06)

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Dabigatran Etexilate Capsules 75 mg Bottle Label (Image 07)

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Figure 2. Kaplan-meier Curve Estimate Of Time To First Stroke Or Systemic Embolism (Image 08)

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Dabigatran Etexilate Capsules 150 mg Bottle Label (Image 09)

Dabigatran Etexilate Capsules 150 mg Bottle Label (Image 09)
This text contains information about a medication called dabigatran etexilate mesylate, providing details on its dosage, storage instructions, manufacturer, and pharmacist dispensing notes. It also mentions the importance of keeping the medication out of reach of children and the requirement to swallow the capsules whole. The medication must be used within 4 months of opening and is not substitutable with other dosages. It emphasizes storing the medication in the original package to protect it from moisture.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.