Argatroban Injection, Solution
Product Images NDC 55150-241

This is a graph showing the relationship at steady state between Argatroban dose, Plasma Argatroban concentration and anticoagulant effect. The x-axis shows Plasma Argatroban levels in mega per milliliter, ranging from 0 to 2.0 mega per milliliter. The y-axis shows infusion dose in mega per kg per minute, ranging from 0 to 10 mega per kg per minute. The graph shows the anticoagulant effect of Argatroban with increasing doses and plasma concentrations. There is additional text, possibly corrupted during , which is not providing any useful information.*

The text presents a figure showing the INR relationship of Argatroban Plus Warfarin and Warfarin Alone. The data includes information from 24 subjects and is presented in a graph with Warfarin INR values on the x-axis and Argatroban Plus Warfarin INR values on the y-axis. The graph shows that the relationship between Argatroban Plus Warfarin and Warfarin Alone is linear, with a formula provided for the trend line. The text also includes information about thromboplastin A and B, their ISI values, and their relationship to the data presented.*

This figure shows the time-to-first event for the composite efficacy endpoint in HIT patients of Study 1. The study compared Argatroban (N=160, censored=119%) with a historical control group (N=147, censored=90%). The maximum period of follow-up was 37 days. A p-value of 0.007 was obtained. "Censored" denotes the absence of a clinical endpoint (death, amputation, or new thrombosis) during the follow-up period.*

This is a description of the results for the composite efficacy endpoint for HITTS patients in Study 1. Figure 4 shows the time-to-first event for this endpoint with data for the treatment group of Argatroban (N=144) presented. The results indicate a statistically significant p-value of 0.018. The study lasted for up to 37 days and clinical endpoints defined as death, amputation, or new thrombosis were not observed during the follow-up period for 81 patients.*

This is a product label for an injection containing the medication argatroban, with additional ingredients including sorbitol and sodium chloride. The dosage information is available in the package insert. The product should be stored at a controlled room temperature between 20° to 25°C, with some variation allowed. The product should be protected from light and should not be refrigerated or frozen. The label has been produced by AuroMedics Pharma LLC and is intended for medicinal use only under prescription.*

Argatroban is a medication available in a 50mg per 50mL dosage, for intravenous infusion only. It is a sterile, non-pyrogenic solution that should not be diluted prior to administration. The vial stopper is not made of natural rubber latex. The packaging includes a single-dose vial that should be discarded if unused. The usual dosage should be referred to in the package insert, and it is important to keep this drug out of reach of children. The medication should not be used if the solution is cloudy or contains a precipitate, and it should be protected from light and stored in the original carton. The solution should not be refrigerated or frozen. The medication is distributed by AuroMedics Pharma LLC and made in India.*

This is a description of a medication called Argatroban in 0.9% Sodium Chloride Injection. It is available in single-dose vials of 50 mg per 50 mL. The medication is intended for intravenous infusion only and should not be diluted before administration. Unused portions must be discarded. The medication must be protected from light and kept at room temperature between 15°C and 30°C (59°F and 86°F). The package insert should be consulted for dosage information. Sterility and non-pyrogenicity are guaranteed. The medication is distributed by AuroMedics Pharma LLC, located in Windsor, NJ.*