Technetium Tc 99m Sestamibi Injection
Product Images NDC 69945-092

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Technetium Tc 99m Sestamibi (NDC 69945-092). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Curium 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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Technetium Tc 99m Sestamibi Injection Kit 69945 1

This table shows the estimated radiation absorbed doses for various organs in the body from Tca9m Sestamibi. The information is presented for different time periods and levels of activity in the body. The table includes details about the radiation absorbed dose measured in Tads/mGyT or rads/μGy. The organs included in the table are breasts, gallbladder wall, small intestine, upper and lower large intestine wall, stomach wall, heart wall, kidneys, liver, lungs, bone surfaces, thyroid, ovaries, testes, red marrow, urinary bladder wall, and total body.*

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Technetium Tc 99m Sestamibi Injection Kit 69945 10

This is a table presenting the results of a study that used technetium Tc99m sestamibi to identify target lesions in patients with non-palpable and palpable mass abnormal mammograms. The table includes data on sensitivity, specificity, positive predictive value, negative predictive value, agreement, and prevalence for two different studies. The data is presented as numbers and percentages, and some patients had more than one target lesion. There were some exclusions made in the study, as stated in the notes.*

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Technetium Tc 99m Sestamibi Injection Kit 69945 11

The text describes the degree of technetium Tc99m sestamibi breast imaging uptake in patients with mammographically detected non-palpable and palpable lesions in comparison to histopathology results. The degree of uptake is categorized as normal, equivocal, and low, moderate, or high. The percentage of non-malignant and malignant lesions for each category of uptake is provided, along with median findings for three blinded readers. The study also includes information on the benign tissue, fibroadenoma, benign intramammary nodes, and radial scar.*

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Technetium Tc 99m Sestamibi Injection Kit 69945 12

Kit for the Preparation of Technetium Tc 99m Sestamibi Injection is a product used for intravenous use after labeling with additive-free technetium. It contains various ingredients such as Ttrakis, Stannous Chloride Dihydrate, L-Gysteine Hydrochloride monohydrate, Sodium Gtrate Dihydrate and Mannitol. The pH of the product is adjusted to 5.6 to 5.7 with HCl or NaOH prior to lyophilization, and it is sealed under nitrogen. It needs to be stored at a temperature ranging from 15°C to 25°C, away from light. Full prescribing information is available in the package insert. Made by Curium US LLC.*

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Technetium Tc 99m Sestamibi Injection Kit 69945 2

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Technetium Tc 99m Sestamibi Injection Kit 69945 3

The table shows the different adverse events reported in patients (men and women) who received Technetium Tc99m Sestamibi in breast or cardiac clinical studies. The adverse events are categorized by body system and include headache, chest pain/angina, nausea, and taste perversion, among others. The table excludes 22 patients whose gender was not recorded.*

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Technetium Tc 99m Sestamibi Injection Kit 69945 4

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Technetium Tc 99m Sestamibi Injection Kit 69945 5

This is a table showing the principal radiation emission data of Gamma-2. The mean percentage of disintegration energy emitted by Gamma-2 is 89.07, and the mean energy emitted is 1405 KeV.*

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Technetium Tc 99m Sestamibi Injection Kit 69945 6

This is a table showing the radiation attenuation caused by different thicknesses of lead shielding. The table includes the thickness in centimeters and the coefficient of attenuation, which measures how much the radiation is reduced by the shielding. The shielding thicknesses range from 0.017 cm to 0.33 cm.*

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Technetium Tc 99m Sestamibi Injection Kit 69945 7

This is a physical decay chart for Tc99m, with a half-life of 6.02 hours. It shows the fraction of remaining material at different time intervals, ranging from 0 to 12 hours. The calibration time is not specified.*

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Technetium Tc 99m Sestamibi Injection Kit 69945 8

Table 6.0 presents data on the biological and effective clearance rates for the heart and liver during REST and STRESS across different time intervals (5 min, 30 min, 1 hour, 2 hours, and 4 hours). The data shows the amount of clearance achieved for each biological and effective measure at each time interval.*

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Technetium Tc 99m Sestamibi Injection Kit 69945 9

The text presents Table 7.0 related to Cardiac Events. It shows the proportion of patients with events by scan results, proportion of scan results in patients with events, and proportion of event-free patients by scan results. Patients who had pharmacologic stress Tcogm-Sestamibi imaging were studied, and similar findings were obtained. The data indicates that the proportion of patients with abnormal scan results is higher than normal scan results, which is statistically significant (p<0.01).*

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