Rocuronium Bromide Injection, Solution
Product Images NDC 51662-1545

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Rocuronium Bromide (NDC 51662-1545). 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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Vial Label (51662 1542 1 Etomidate Injection Vial Label)

Label for Rocuronium Bromide Injection 100 mg per 10 mL (10 mg/mL) by AuroMedics Pharma LLC. It is a sterile, nonpyrogenic intravenous solution, provided in a 10 mL multiple dose vial. The label includes warnings about its paralyzing effects and storage instructions, stating to refrigerate between 2° to 8°C and not to freeze.*

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Serialized Label (51662 1545 1 Serialized Label)

Rocuronium Bromide injection, solution in a 10 mL vial containing 100 mg per 10 mL (10 mg/mL) strength. The vial features a yellow and red cap and displays labeling with product name, strength, usage warning, and distribution information by HF Acquisition Co LLC, Mukilteo, WA.*

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1 (Clinical P 1)

A data table presenting the percentage of patients with excellent or good intubating conditions and the median time to completion of intubation after rocuronium bromide dose administration over 5 seconds. It includes data for adults (18 to 64 years), infants (3 months to 1 year), and pediatric patients (1 to 12 years) receiving specific doses, with time to intubation ranging from 1 to 7 minutes.*

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10 (Clinical P 10)

A data table titled 'Table 10: Mean (SD) Pharmacokinetic Parameters of Rocuronium in Pediatric Patients During Sevoflurane (induction) and Isoflurane/Nitrous Oxide (maintenance) Anesthesia.' It presents pharmacokinetic parameters including clearance, volume of distribution, and half-life across patient age ranges from birth to under 28 days up to 11 to under 17 years.*

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2 (Clinical P 2)

Table showing median and range for time to onset and clinical duration after initial Rocuronium Bromide dose during anesthesia with Nitrous Oxide/Oxygen and Halothane in pediatric and adult patients. It lists doses by age group and weight, with columns for time to 80% block, time to maximum block, and clinical duration in minutes.*

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3 (Clinical P 3)

A data table titled 'Table 6' presenting median and range values for time to onset and clinical duration after initial intubating doses of Rocuronium Bromide during anesthesia in pediatric patients. It details doses by age group, time to maximum block, and time to reappearance of T3, categorized for neonates, infants, toddlers, children, and adolescents.*

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4 (Clinical P 4)

A box plot chart titled 'Time to 80% or Greater Block vs. Initial Dose of Rocuronium Bromide by Age Group' showing median, 25th and 75th percentiles, and individual values. The x-axis categorizes doses in mg/kg for three age groups: 18 to 64 years, 65 years and older, and 1 to 12 years. The y-axis represents time in minutes, displaying variations in time to achieve 80% block for different doses of rocuronium bromide by age.*

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5 (Clinical P 5)

A scatter box plot chart comparing duration of clinical effect in minutes versus initial dose of Rocuronium Bromide by age group. Data includes median, 25th and 75th percentiles, and individual values for doses in mg/kg across various age groups from 3 months to 64 years and older.*

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6 (Clinical P 6)

A line graph titled 'Duration of Clinical Effect vs. Number of Rocuronium Bromide Maintenance Doses, by Dose' showing minutes of clinical effect on the vertical axis and dose number on the horizontal axis. Two lines represent dosage groups: 0.15 mg/kg (N=13) showing duration approximately 15 to 20 minutes, and 0.1 mg/kg (N=29) showing duration approximately 10 to 13 minutes across doses 1 to 5.*

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7 (Clinical P 7)

A data table presenting mean and standard deviation pharmacokinetic parameters of rocuronium bromide in adult and geriatric patients during opioid/nitrous oxide/oxygen anesthesia. It compares clearance, volume of distribution, and elimination half-life between adults (ages 27 to 58 years) and geriatrics (65 years or greater).*

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8 (Clinical P 8)

A table presenting mean and standard deviation pharmacokinetic parameters for adults with normal renal and hepatic function, renal transplant patients, and hepatic dysfunction patients during isoflurane anesthesia. Parameters include clearance, volume of distribution at steady state, and half-life beta elimination with corresponding values for each patient group.*

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9 (Clinical P 9)

A data table presenting mean and standard deviation pharmacokinetic parameters of Rocuronium in pediatric patients of various age ranges (3 to less than 12 months, 1 to less than 3 years, and 3 to less than 8 years) during halothane anesthesia. Parameters include clearance, volume of distribution at steady state, and elimination half-life.*

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T1 (Clinical T1)

A data table titled 'Infusion Rates Using Rocuronium Bromide Injection (0.5 mg/mL)' showing infusion delivery rates in mL/hr for varying patient weights (in kg and lbs) across different drug delivery rates in mcg/kg/min, ranging from 4 to 16 mcg/kg/min. The table provides specific infusion rate values for patient weights from 10 kg to 100 kg.*

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T2 (Clinical T2)

A table titled 'Infusion Rates Using Rocuronium Bromide Injection (1 mg/mL)' presenting infusion delivery rates (mL/hr) based on patient weight in kilograms and pounds, and drug delivery rate in mcg/kg/min. The patient weights range from 10 kg to 100 kg, and drug delivery rates from 4 to 16 mcg/kg/min.*

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T3 (Clinical T3)

A data table titled 'Infusion Rates Using Rocuronium Bromide Injection (5 mg/mL)' showing patient weight in kilograms and pounds, with corresponding drug delivery rates in mcg/kg/min and infusion delivery rates in mL/hr. The table provides detailed infusion rate values for various patient weights ranging from 10 to 100 kg and drug delivery rates from 4 to 16 mcg/kg/min. A footnote indicates the solution contains 500 mg rocuronium bromide in 100 mL.*

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Structure (Structure)

Chemical structure of Rocuronium Bromide, showing its detailed molecular formula with atoms and bonds, including a bromide ion (Br-). This depicts the molecular arrangement of the active ingredient found in the Rocuronium Bromide injection solution.*

* 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.