Precedex Injection, Solution, Concentrate
Product Images NDC 0404-9938

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Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Precedex (NDC 0404-9938). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Henry Schein, 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.

FDA Label Image

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FDA Label Image

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This text provides a Table 9 that shows the Ramsay Level of Sedation Scale with corresponding clinical scores and levels of sedation achieved, ranging from asleep with no response to anxious or agitated.*
FDA Label Image

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Table 10 shows the results of a study (ITT) on the use of Midazolam as a rescue medication during intubation. The study involved two groups of patients, one receiving a placebo and the other receiving Precedex. The mean total dose of Midazolam administered to the patients in the placebo group was 19mg, while the mean total dose administered to the Precedex group was 5mg. The difference was found to be statistically significant (p-value=0.0011). The study found that 25% of patients in the placebo group did not receive any Midazolam, while 61% of patients in the Precedex group did not. The study population included all randomized patients, and an ANOVA model with treatment center was used for analysis.*
FDA Label Image

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The table presents data on the use of propofol as a rescue medication during intubation for Study Two. The study compared the use of Propofol and Placebo Precedex for the indicated purpose. The table shows the mean total dose of Propofol, standard deviation and the categorized use of Propofol between the Placebo Precedex group (N=198) and the Propofol group (N=203). The ANOVA model with treatment c and Chi-square results are also included.*
FDA Label Image

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This is a table presenting the Observer's Assessment of Alertness/Sedation, with different categories such as responsiveness, speech, facial expression, and eye response. Each category has a score representing different levels of alertness/sedation, ranging from scores of 5 for being alert and responsive to scores of 1 for being in a state of deep sleep and not responding to prodding or shaking.*
FDA Label Image

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The text provides a table (Table 13) displaying key efficacy results of Procedural Sedation Studies. The table includes information on the number of patients enrolled, percentage not requiring rescue treatment, confidence interval, mean and standard deviation of total dose of midazolam administered, and confidence intervals of the mean rescue dose required for each treatment arm. The studies evaluated dexmedetomidine 0.5 meg/kg and 1 meg/kg infusion and placebo. The text also notes that the ITT population, defined as all randomized and treated patients, was used to generate the results.*
FDA Label Image

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This is a prescription medication identified by the National Drug Code (NDC) 0409-1638-02. It comes in a vial container with a size of 2mL.*
FDA Label Image

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This is a list of National Drug Codes (NDC) and their corresponding containers and sizes. The NDC numbers listed are 0409-1660-20, 0409-1660-50, 0409-1660-10, and 0409-1434-01. The containers are vials and bottles, and the sizes range from 20 mL to 250 mL.*
FDA Label Image

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PRECEDEX (DEXMEDETOMIDINE HCL) is a drug available in 200mcg/2ml single dose vials for intravenous use. The solution is preservative-free and must be diluted before use. It is important to keep the drug out of children's reach and store it at 20 to 25°C (58 to 77°F). The drug is packaged by Henry Schein, Inc. and can be identified by NDC: B454-3338-62 and ITEM #: 2480914. The other texts seem to be unclear due to errors.*

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