Cardinal Health 414, LLC's Kit for the Preparation of Technetium TC 99M Sestamibi Injection is not to be used with the Recon-o-Stat™ thermal cycler due to the smaller vial size requirements of this heating device. ** 95% Confidence Intervals are based on meta-analysis and represent the spread in the individual estimates. Table 11 shows the tracer localization rates where the tracer localization rate (%) is defined as the percentage of patients who had at least one lymph node containing the specific tracer. Preparation of the Technetium TC 99M Sestamibi from the Kit for Preparation of Technetium Tc 99m Sestamibi Injection is done by the following aseptic procedure: Note: Adherence to the above product reconstitution instructions is recommended. The contents are sealed under nitrogen. The reports were insufficient to establish the basis for failed tracer localization. The Technetium TC 99M Sestamibi scintigraphic images were read in a randomized method by two groups of three blinded readers. Product should be used within 6 hours after preparation. For anterior images, position the patient supine with both arms behind the head. 2Data supplied by Oak Ridge Associated Universities, Radiopharmaceutical Internal Dose Information Center, 1986. discard after six (6) hours from the time of preparation. Interference from chest wall lesions such as breast tumors and healing rib fractures can be minimized by employing the three recommended projections. When comparing weight-adjusted radioactivity (up to 0.3 mCi/kg) doses administered to adolescents and younger children to the recommended dose administered to adults (up to 30 mCi), the radiation absorbed doses in both adolescents and younger children were similar to those in adults. However, after sodium pertechnetate Tc 99m is added, adequate shielding of the final preparation must be maintained. An initial marker image, that was not used in the data analysis, was obtained using a cobalt Co57 point source as a marker of a palpable mass. It is also concentrated in the injured myocardium, primarily in areas of irreversibly damaged myocardial cells. Low, Moderate or High Uptake The TechneScan PYP Kit must be maintained in a refrigerator, 2° to 8°C (36° to 46°F) until use. The standard of truth was defined as cardiac events occurring 6 months following the administration of Technetium TC 99M Sestamibi. Each 10mL multi-dose Reaction Vial contains, in lyophilized form, 2 mg sodium thiosulfate anhydrous, 2.3 mg edetate disodium and 18.1 mg bovine gelatin; each Solution A vial contains 1.8 mL 0.148 N hydrochloric acid solution and each Solution B vial contains 1.8 mL aqueous solution of 24.6 mg/mL sodium biphosphate anhydrous and 7.9 mg/mL sodium hydroxide. Assumptions: Calculations for the absorbed radiation dose are based upon an effective half-time of 3 hours for the open shunt and 6.02 hours for the closed shunt and an even distribution of the radiopharmaceutical in the peritoneal cavity with no biological clearance. Available for Android and iOS devices. Therefore, formula feedings should be substituted for breast feedings. Myocardial uptake which is coronary flow dependent is 1.2% of the injected dose at rest and 1.5% of the injected dose at exercise. Technescan™ PYP™ (Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection) is a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous administration after reconstitution with sterile sodium pertechnetate Tc 99m injection or sterile 0.9% sodium chloride injection. Both prior to and following administration of Technetium Tc 99m Pyrophosphate Injection, patients should be encouraged to drink fluids. As shown in Table 9 and Table 10, the majority of the normal Technetium TC 99M Sestamibi images are associated with non-malignant tissue (78–81%) and the majority of low, moderate or high uptake Technetium TC 99M Sestamibi images are associated with malignant disease (79–83%). No clinically meaningful measurements of sensitivity, specificity or other diagnostic performance parameters could be demonstrated in this study. Definitive human studies to demonstrate possible redistribution have not been reported. Allow to stand for five (5) minutes at room temperature. If considering Technetium TC 99M Sulfur Colloid Injection administration to a pregnant woman, inform the patient about the potential for adverse pregnancy outcomes based on the radiation dose from the drug and the gestational timing of exposure. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker. 1Bergqvist L, Strand S-E, Persson B, et al. Use within 6 hours after labeling with Technetium Tc 99m. Whether these lesions were benign or malignant is not known. Heparinized catheter systems should be avoided. The syringe is gently rotated to mix and allowed to incubate at room temperature for 10 minutes prior to injection via the 3-way stopcock. Twenty-seven percent of the injected dose is excreted in the urine, and approximately thirty-three percent of the injected dose is cleared through the feces in 48 hours. Using proper shielding, the reaction vial should be visually inspected. Several adverse reactions due to the use of Technetium Tc 99m Pyrophosphate Injection have been reported. These lesions were not biopsied. Proportion of scan result in patients with events; N=24, Proportion of event-free patients by scan results, Kit for the Preparation of Technetium Tc99m, kit for the preparation of technetium tc99m sestamibi injection, powder, lyophilized, for solution, We comply with the HONcode standard for trustworthy health information -, Drug class: radiologic conjugating agents. In a clinical pharmacology study, 46 pediatric patients with Kawasaki disease received Technetium TC 99M Sestamibi administration at the following doses: 0.1–0.2 mCi/kg for rest, 0.3 mCi/kg for stress in one day studies; 0.2 mCi/kg for rest and 0.2 mCi/kg for stress in two day studies. In 11 of these patients the pain appears to be associated with biopsy/surgical procedures. These were usually flushing, hypotension, fever, chills, nausea, vomiting and dizziness, as well as hypersensitivity reactions such as itching and various skin rashes. Contents of the kit before preparation are not radioactive. Usual Dosage: See complete prescribing information. DOE/TIC-11026: 108, 1981. The period of time for collecting the images may range up to thirty-six hours. Although patients with normal images had a lower cardiac event rate than those with abnormal images, in all patients with abnormal images it was not possible to predict which patient would be likely to have further cardiac events; i.e., such individuals were not distinguishable from other patients with abnormal images. Equivocal results do not have a correlation with histology. The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration. Maryland Heights, MO 63043, (Stannous Pyrophosphate) The agent is excreted without any evidence of metabolism. Technetium TC 99M Sestamibi evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g., exercise or pharmacologic stress in accordance with the pharmacologic stress agent’s labeling). At five minutes post injection about 8% of the injected dose remains in circulation. In separate retrospective subset analyses of 259 patients with dense (heterogeneously/extremely dense) and 275 patients with fatty (almost entirely fat/numerous vague densities) breast tissue, the Technetium TC 99M Sestamibi results were similar. Cardiac imaging should be done 10 minutes following the administration of sodium pertechnetate Tc 99m (in vivo method) or Tc 99m labeled red blood cells (modified in vivo/in vitro method) utilizing a scintillation camera interfaced to an electrocardiographic gating device. Disease localization isolated to the apex has not been established. TechneScan PYP also has an affinity for red blood cells. The first half value layer is 0.017 cm of Pb. Modified In Vivo/In Vitro Method Using Heparin: TechneScan PYP is reconstituted with sterile, non-pyrogenic normal saline containing no preservatives, and the patient dose is administered intravenously. The pH of the reconstituted product is 5.5 (5.0–6.0). TechneScan PYP should be injected by direct venipuncture. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 8. The radiation absorbed doses in adolescents, both at rest and stress, were similar to those observed in adults [see Dosage and Administration (2.2)]. Scintigraphic images obtained in humans after the intravenous administration of the drug have been comparable to those obtained with thallous chloride Tl-201 in normal and abnormal myocardial tissue. Within these four studies, the number of reported patients ranged from 12 to 94. For Breast Imaging: The recommended dose range for I.V. A systematic review of eight publications examined the use of Technetium TC 99M Sulfur Colloid and a blue dye (tracers) to assist surgeons in the localization of lymph nodes among patients with malignant melanoma. N = 66 lesions, Low, Moderate or High Uptake Adverse events reported at a rate of 0.5% or greater after receiving Technetium TC 99M Sestamibi administration are shown in the following table: In the clinical studies for breast imaging, breast pain was reported in 12 (1.7%) of the patients. administration of Technetium Tc 99m Sestamibi is a single dose of 740–1110 MBq (20–30 mCi). The resulting solution should be clear and free of particulate matter. For complete study, sets of images should be obtained five minutes after the injection, and in the following sequence: Beginning five minutes after the injection of Technetium TC 99M Sestamibi: The radiation doses to organs and tissues of an average patient (70 Kg) per 1110 MBq (30 mCi) of Technetium TC 99M Sestamibi injected intravenously are shown in Table 1. When injected intravenously, Technetium Tc 99m Pyrophosphate has a specific affinity for areas of altered osteogenesis. Study A Any sodium pertechnetate Tc 99m solution which contains an oxidizing agent is not suitable for use in the preparation of Technetium Tc 99m Pyrophosphate Injection. * Percentage of procedures in which at least one lymph node contained the specific tracer; the percents do not add to 100% due to rounding. For either lateral or anterior images, shield the chest and abdominal organs, or remove them from the field of view. In general, most patients had resected lymph nodes that contained at least one of the tracers. Available for Android and iOS devices. Specific drug-drug interactions have not been studied. The 1-year old “S” values were taken from phantom work of the Metabolism and Dosimetry Group at ORNL. Cases of angina, chest pain, and death have occurred [see Warnings and Precautions (5)]. Radiochemical purity should be checked prior to patient administration. False negative images can also occur if made too early in the evolutionary phase of the infarct or too late in the resolution phase. However, in some patients (estimated at approximately 1.6%) neither tracer was localized to a resected lymph node. Images were obtained 5 minutes after injection as follows: lateral image of the affected breast for 10 minutes, lateral image of the contralateral breast for 10 minutes, and an anterior image of both breasts for 10 minutes. Have emergency resuscitation equipment and personnel immediately available. Rx only STORE AT 20-25°C (68-77°F) [See USP], Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821. Although reported clinical experience has not identified differences in response between elderly and younger patients, greater sensitivity of some older individuals cannot be ruled out. Lymph nodes that contained radioactivity were generally localized based upon increased counts, in comparison to a background threshold (e.g., nodes containing a minimum of radioactive counts 3 times higher than background). 1The ethanol used in this procedure should be 95% or greater.

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