Rocuronium Bromide Injection, Solution
Product Images NDC 51662-1546

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Rocuronium Bromide (NDC 51662-1546). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Hf Acquisition Co Llc, Dba Healthfirst, 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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1 (Clinical 1)

A table presenting clinical data for Rocuronium Bromide doses administered over 5 seconds. It shows percent of patients with excellent or good intubating conditions and time to completion of intubation in minutes for adults (18-64 years), infants (3 months to 1 year), and pediatric patients (1 to 12 years) at specified dose levels.*

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10 (Clinical 10)

A data table showing pharmacokinetic (PK) parameters of Rocuronium Bromide injection by patient age range. Parameters include clearance (CL), volume of distribution, and half-life (t1/2 ß), with values provided for age groups from birth to less than 28 days up to 11 to 17 years.*

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2 (Clinical 2)

A data table presenting Rocuronium Bromide dosing information by age groups (Adults 18-64 years, Geriatric 65+, Infants 3 months to 1 year, Pediatric 1 to 12 years). It includes columns for dose in mg/kg administered over 5 seconds, time to ≥80% block (minutes), time to maximum block (minutes), and clinical duration (minutes) with ranges and sample sizes where available.*

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3 (Clinical 3)

A data table showing Rocuronium Bromide dosage (mg/kg) administered over 5 sec, with columns for time to maximum block (minutes) and time to reappearance of T3 (minutes). The table presents this data segmented by age groups: neonates birth to under 28 days, infants 28 days to 3 months, toddlers over 3 months to 2 years, children over 2 to 11 years, and adolescents 11 to 17 years, including dose response values and sample sizes (n).*

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4 (Clinical 4)

A box and whisker plot titled 'Time to 80% or Greater Block vs. Initial Dose of Rocuronium Bromide by Age Group.' The x-axis shows Rocuronium Bromide dose in mg/kg for three age groups (18 to 64 years, 65 years and older, and 1 to 12 years), and the y-axis shows time in minutes. The plot displays median, 25th and 75th percentiles, and individual data points for each dose and age group combination.*

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5 (Clinical 5)

A scatter and box plot chart titled 'Duration of Clinical Effect vs. Initial Dose of Rocuronium Bromide by Age Group.' The y-axis measures duration in minutes from 0 to 160. The x-axis shows doses in mg/kg for age groups: 18 to 64 years, 65 years and older, 3 months to 1 year, and 1 to 12 years. Individual data points and distribution summaries are displayed for each dose and age group combination.*

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6 (Clinical 6)

A line graph titled 'Duration of Clinical Effect vs. Number of Rocuronium Bromide Maintenance Doses, by Dose,' showing duration in minutes on the y-axis and dose number on the x-axis. Two lines represent dose levels 0.15 mg/kg and 0.1 mg/kg with corresponding sample sizes (N=13 and N=29). Duration generally increases with dose number, with the higher dose showing longer effect duration.*

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7 (Clinical 7)

A data table comparing pharmacokinetic parameters of Rocuronium Bromide in adults (ages 27 to 58 years) and geriatrics (≥65 years). It includes values for clearance, volume of distribution at steady state, and half-life elimination, with mean and standard deviation for each parameter in the two age groups.*

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8 (Clinical 8)

A data table presenting pharmacokinetic (PK) parameters of rocuronium bromide, including clearance, volume of distribution at steady state, and half-life beta elimination, across normal renal and hepatic function, renal transplant patients, and hepatic dysfunction patients.*

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9 (Clinical 9)

A data table presenting pharmacokinetic (PK) parameters for Rocuronium Bromide injection in patients across three age ranges: 3 to less than 12 months, 1 to less than 3 years, and 3 to less than 8 years. Parameters include clearance (L/kg/hr), volume of distribution at steady state (L/kg), and beta elimination half-life (hours), each with mean values and standard deviations.*

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Dosage (Dosage)

Three tables presenting infusion rates using Rocuronium Bromide Injection at concentrations of 0.5 mg/mL, 1 mg/mL, and 5 mg/mL. Each table shows infusion delivery rates in mL/hr according to patient weight (kg and lbs) and drug delivery rates (mcg/kg/min). Notes specify mg amounts of Rocuronium Bromide per 100 mL of solution for each concentration.*

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Structure (Structure)

Chemical structure of rocuronium bromide showing its steroidal backbone with various functional groups including an acetyl group, hydroxyl group, and a bromide ion associated with the molecule.*

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Serialized Label (Serialized Vial Labeling)

Rocuronium Bromide Injection 50 mg per 5 mL (10 mg/mL) vial with a yellow top and red band below the cap. The label includes a warning indicating it is a paralyzing agent and for intravenous use only. Distributed by HF Acquisition Co., LLC, Mukilteo, WA 98275. The vial is a multiple dose form with 5 mL volume.*

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Vial 2 (Vial Label (2))

Label for Rocuronium Bromide Injection, 50 mg per 5 mL (10 mg/mL), a paralyzing agent for intravenous use. The label includes warnings about respiratory arrest and the need for artificial respiration facilities, storage instructions to refrigerate between 2° to 8°C (36° to 46°F) and not to freeze, and usage timelines. It is manufactured in India for AuroMedics Pharma LLC and distributed by HF Acquisition Co LLC, DBA HealthFirst, with NDC 51650-225-05.*

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Vial 1 (Vial Label)

Label for Rocuronium Bromide Injection, 50 mg per 5 mL (10 mg/mL), an intravenous injection solution. The label includes warnings about its paralyzing effects and the necessity of facilities for artificial respiration. It specifies storage instructions, manufacturer information (AuroMedics Pharma LLC), and indicates it is a 5 mL multiple-dose vial.*

* 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.