Argatroban Injection, Solution
Product Images NDC 55150-241

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Argatroban (NDC 55150-241). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Eugia Us Llc, 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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Figure 1. Relationship At Steady State Between Argatroban Dose, Plasma Argatroban Concentration And Anticoagulant Effect (Argatroban Fig1)

A figure showing the relationship at steady state between Argatroban infusion dose (mcg/kg/min) on the x-axis and plasma Argatroban concentration (mcg/mL) at the top x-axis, plotted against two coagulation test measures: aPTT (seconds ± SEM) on the left y-axis represented by squares, and ACT (seconds ± SEM) on the right y-axis represented by circles. Both measures increase with increasing infusion dose and plasma concentration.*

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Figure 2. Inr Relationship Of Argatroban Plus Warfarin Versus Warfarin Alone (Argatroban Fig2)

A scatter plot titled 'INR Relationship of Argatroban Plus Warfarin Versus Warfarin Alone' showing data from 24 subjects. It compares INR values with Argatroban plus Warfarin (y-axis) against Warfarin alone (x-axis). Two regression lines represent Thromboplastin A (ISI = 0.88) and Thromboplastin B (ISI = 1.78) with corresponding linear equations and a confidence interval for Warfarin INR prediction.*

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Figure 3. Time-to-first Event For The Composite Efficacy Endpoint: Hit Patients Study 1 (Argatroban Fig3)

A Kaplan-Meier survival curve titled 'Time-to-First Event for the Composite Efficacy Endpoint: HIT Patients STUDY 1' showing proportion event-free over study days up to 37. Two groups are compared: Argatroban (N=160) with a higher event-free proportion, and Historical Control (N=147) with lower event-free proportion. A p value of 0.007 is indicated, with censored data noted in the legend.*

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Figure 4. Time-to-first Event For The Composite Efficacy Endpoint: Hitts Patients Study 1 (Argatroban Fig4)

A Kaplan-Meier survival curve chart showing time-to-first event for the composite efficacy endpoint in HITTS patients from Study 1. The y-axis shows the proportion event-free, and the x-axis shows study days up to 35. Two groups are compared: Argatroban (N=144) and Historical Control (N=46). The chart includes a p value of 0.018 and notes that censoring indicates no clinical endpoint observed during follow-up (up to 37 days).*

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Package Label-principal Display Panel (50 mg per 50 mL (1 mg / mL))

Label for Argatroban 50 mg/50 mL solution for intravenous injection in 0.9% Sodium Chloride. Contains 1 mg argatroban per mL, with sodium chloride and sorbitol. Includes storage instructions, manufacturer info (AuroMedics Pharma LLC), and barcode. The label is primarily white with blue and black text.*

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Package Label-principal Display Panel (50 mg per 50 mL (1 mg / mL) – Container-Carton (10 Vials))

Argatroban in 0.9% Sodium Chloride Injection 50 mg per 50 mL (1 mg/mL) IV infusion solution carton label. The label includes dosage strength, route, and warnings such as not to dilute prior to administration and to discard unused portion. It indicates a 50 mL single-dose vial, sterile, non-pyrogenic. Distributed by AuroMedics Pharma LLC, made in India, with storage instructions and components listed.*

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Argatroban Fig7

Label for Argatroban in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg/mL) intravenous infusion solution. The label shows 10 x 50 mL single dose vials. It is sterile, non-pyrogenic, and distributed by AuroMedics Pharma LLC. Storage and usage instructions are also included on the label.*

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Argatroban Chemical Structure (Argatroban Str)

Chemical structure of Argatroban, showing its molecular components including a sulfonamide group, a cyclohexane ring with a carboxylic acid group, and associated functional groups including an amidine group and water of hydration (H2O).*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.