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.

FDA Label Image

Technetium Tc 99m Sestamibi Injection Kit 69945 1

Data table showing estimated radiation absorbed doses from Technetium Tc 99m Sestamibi by organ under conditions of rest and stress, measured at 2.0 hour and 4.8 hour void times. Values are given in rads and mGy for various organs and body tissues for a dosage of 30 mCi (1110 MBq).*

FDA Label Image

Technetium Tc 99m Sestamibi Injection Kit 69945 10

A data table titled 'TABLE 8.0 Overall Technetium Tc99m Sestamibi Blinded Results of Target Lesions Identified at Study Entry' comparing Study A (Non-Palpable Mass and an Abnormal Mammogram) with Study B (Palpable Mass). The table lists statistics including number of patients and lesions, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), agreement, and prevalence with corresponding values and confidence intervals.*

FDA Label Image

Technetium Tc 99m Sestamibi Injection Kit 69945 11

The image shows two data tables labeled TABLE 9.0 and TABLE 10.0 presenting the degree of Technetium Tc99m Sestamibi breast imaging uptake compared to histopathology results. TABLE 9.0 relates to patients with mammographically detected non-palpable lesions (Study A) for 249, 25, and 66 lesions categorized by normal, equivocal, and low/moderate/high uptake across non-malignant and malignant groups. TABLE 10.0 pertains to patients with palpable lesions (Study B) with 129, 32, and 115 lesions similarly categorized. Both tables include notes on median findings for blinded readers and definitions for non-malignant tissue types.*

FDA Label Image

Technetium Tc 99m Sestamibi Injection Kit 69945 12

Label for a kit used in the preparation of Technetium Tc 99m Sestamibi Injection, 1 mg/mL, for intravenous use. It states the product is for use after labeling with additive-free Technetium Tc 99m and provides formulation details including ingredients such as Tetrakis, Copper, Stannous Chloride Dihydrate, L-Cysteine Hydrochloride Monohydrate, Sodium Citrate Dihydrate, and Mannitol. The label notes storage conditions and includes the manufacturer information: Curium US LLC, Maryland Heights, MO, USA.*

FDA Label Image

Technetium Tc 99m Sestamibi Injection Kit 69945 2

Diagram labeled as 'Figure 1.0 TLC Plate Diagram' showing a thin-layer chromatography (TLC) plate with measurements and labeled parts: solvent front near the top, a marked cut line 2.5 cm below the solvent front, and the origin near the bottom of the plate. The vertical dimensions with specific centimeter markings are indicated alongside the plate.*

FDA Label Image

Technetium Tc 99m Sestamibi Injection Kit 69945 3

A data table listing selected adverse events reported in more than 0.5% of patients who received Technetium Tc99m Sestamibi in breast or cardiac clinical studies. It categorizes events by body system and patient groups (women in breast studies, women and men in cardiac studies, and total). The table includes frequency counts and percentages for various adverse events such as headache, cardiovascular issues, and special senses abnormalities.*

FDA Label Image

Technetium Tc 99m Sestamibi Injection Kit 69945 4

Chemical structure diagram of Technetium Tc 99m Sestamibi showing its coordination complex with copper (Cu) at the center, surrounded by ligands. Includes additional boron trifluoride (BF4-) ion representation on the side.*

FDA Label Image

Technetium Tc 99m Sestamibi Injection Kit 69945 5

A data table titled 'Principal Radiation Emission Data' showing radiation type Gamma-2 with mean percent disintegration 89.07% and mean energy 140.5 KeV. The table summarizes key radiation emission characteristics relevant to Technetium Tc 99m Sestamibi.*

FDA Label Image

Technetium Tc 99m Sestamibi Injection Kit 69945 6

A table titled 'Radiation Attenuation by Lead Shielding' listing various lead shield thicknesses in centimeters alongside corresponding coefficients of attenuation. Thickness values range from 0.017 to 0.33 cm, with attenuation coefficients from 0.5 down to 10^-4.*

FDA Label Image

Technetium Tc 99m Sestamibi Injection Kit 69945 7

A physical decay chart table titled 'Table 5.0. Physical Decay Chart; Tc99m Half-Life 6.02 Hours' showing the fraction remaining of Technetium Tc 99m over hours from 0 to 12. The table lists hours alongside the corresponding fraction of the radioactive material remaining at each time point.*

FDA Label Image

Technetium Tc 99m Sestamibi Injection Kit 69945 8

Data table titled 'Table 6.0 Biological and Effective Clearance' showing numerical values of biological and effective clearance for heart and liver at various time points (5 minutes, 30 minutes, 1 hour, 2 hours, 4 hours) under conditions labeled REST and STRESS.*

FDA Label Image

Technetium Tc 99m Sestamibi Injection Kit 69945 9

Table 7.0 titled 'Cardiac Events' showing proportions of patients with events, scan results in patients with events, and event-free patients by scan results categorized as Normal or Abnormal.*

* 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.