Pradaxa Capsule
Product Images NDC 0597-0108

Product Visual Gallery

This gallery contains 11 technical images submitted to the FDA as part of the official labeling for Pradaxa (NDC 0597-0108). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Boehringer Ingelheim 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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Pradaxa 01

This seems to be a table of data related to a study comparing the effects of the two blood-thinning medicines, PRADAXA and Warfarin, on patients with different age groups, weight, medical histories, and other variables. The data shows the percentage of patients who had major bleeding events during the treatment with PRADAXA 150 or Warfarin, and also shows the Hazard ratio for each variable.*

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Pradaxa 02

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Pradaxa 03

This appears to be a graph displaying the aPTT time course with a reference to the PRADAXA dose. The x-axis appears to represent time while the y-axis represents the aPTT value in seconds. There are two horizontal lines at 60 and 80, respectively. The text below the graph indicates that PRADAXA dose should be 150 mg BID when CrCt is greater than 30 mLmin and 75 mg BID when CrCl is € 30 mimin. The text "24" and "72%" may not be related to the graph and their meaning is unclear without additional context.*

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Pradaxa 04

This appears to be a table showing the fold change in pharmacokinetic parameters and 90% confidence intervals for interacting drugs at different time intervals. The drugs and their dosages are listed, and it appears that the drugs may be inhibitors or inducers. There is also a column showing the change relative to reference.*

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Pradaxa 05

This appears to be a table or list of drugs with some additional details such as dosage and frequency. It is possible that this could be related to pharmacokinetics (PK), as there are mentions of "PK Fold Change" and "90% CT." Without further context or information, it is difficult to determine what specific use this text may have.*

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Pradaxa 06

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Pradaxa 07

This appears to be a table of clinical trial data comparing the medication Pradaxa 150 to Warfarin for patients with strokes or systemic embolism. It includes information about patient subgroups based on factors such as age, gender, weight, history of stroke/TIA, and diabetes at baseline. The table also lists the number of patients in each subgroup and the hazard ratio for each subgroup when comparing Pradaxa to Warfarin. However, the table is difficult to interpret without additional context.*

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Pradaxa 08

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Pradaxa 09

Pradaxa is a medication that comes in capsule form, with each capsule containing 110mg of dabigatran etexilate. It is important to swallow the capsule whole and to use the product within 6 months of opening it. The medication guide that comes with the unit of use container provides information on the appropriate dosage. Pradaxa capsules must not be substituted on a mg-to-mg basis with other dabigatran etexilate dosage forms. Store the medication in its original packaging at room temperature and protect from moisture. The text includes information from the manufacturer and the NDC number, but it is missing some important text that may be on the label.*

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Pradaxa 10

Pradaxa is a medication available in capsule form that contains 75 mg dabigatran etexilate mesylate. It is dispensed in a container with an enclosed medication guide and should be stored at 20°C to 25°C in the original package to protect it from moisture. The capsules must be swallowed whole and used within 6 months of opening. It is essential to see the package insert for dosage information. Substituting Pradaxa capsules with other dabigatran etexilate dosage forms is not recommended. Pradaxa is manufactured in Germany and distributed by Boehringer Ingelheim Pharmaceuticals, Inc.*

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Pradaxa 11

Pradaxa (dabigatran etexilate) is a medication that comes in capsules with each capsule containing 150 mg dabigatran etexilate equivalent to 172.95 mg dabigatran etexilate mesylate. These capsules should be swallowed whole and should be used within six months of opening. It is important to note that Pradaxa capsules cannot be substituted based on milligram potency with other dabigatran etexilate dosage forms. The usual dosage should be determined using the package insert. The capsules should be stored in the original package to prevent moisture damage and the bottle should be tightly closed.*

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