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Sodium Iodide I-131 Therapeutic
2.1 Radiation Safety
Sodium Iodide I 131 Solution emits radiation and must be handled with safety measures to minimize inadvertent radiation exposure to clinical personnel and patients [see Warnings and Precautions (5.7)].
Radiopharmaceuticals should be used only by or under the direction of physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Wear waterproof gloves during the entire sodium iodide I-131 solution handling and administration procedure. Maintain adequate shielding during the radiation-emitting life of the product. Measure the patient dose using a suitable radioactivity calibration system immediately prior to administration.2.2 Hyperthyroidism
For hyperthyroidism, the usual sodium iodide I-131 dose range is 148 to 370 MBq (4 to 10 mCi). Higher doses may be necessary for the treatment of toxic nodular goiter and other special situations. Consider discontinuation of anti-thyroid therapy in a severely hyperthyroid patient three to four days before administration of sodium iodide I-131. Evaluate patients for risk of thyroid enlargement and obstruction of structures in the neck [see Warnings and Precautions (5.1, 5.2)].
2.3 Thyroid Carcinoma
For thyroid carcinoma, the usual sodium iodide I-131 therapeutic dose is 3700 to 5550 MBq (100 to 150 mCi). For ablation of post-operative residual thyroid tissue, the usual dose is 1850 MBq (50 mCi).
2.4 Individualization of Therapy
Individualize sodium iodide I-131 therapy, including dose selection, based upon patient-specific factors such as the nature of the underlying condition, co-morbidities, age, estimated thyroid tissue iodine uptake, thyroid size, as well as ability of the patient to comply with the therapeutic regimen and radiation safety procedures. Perform a clinical assessment, including history, physical examination and laboratory testing when preparing patients for sodium iodide I-131 therapy in order to detect conditions which may alter thyroid iodine uptake and increase the risks of the therapy or diminish its effectiveness. For example, intake of iodine in radiographic contrast may diminish thyroid iodine uptake while low serum chloride or nephrosis may increase thyroid iodine uptake. Obtain a drug history and ascertain whether any medications need to be withheld before the administration of the therapy [see Drug Interactions (7)].
2.5 Radiation Dosimetry
The estimated absorbed radiation doses1 to an average (70 kg) euthyroid (normal functioning thyroid) patient from an oral dose of iodine-131 in both milligray (mGy) per megabecquerel (MBq) and rad per millicurie (mCi) are shown in Table 1.
Table 1. Absorbed Radiation Doses
Tissue
Thyroid Uptake
5%
15%
25%
mGy/MBq
rads/mCi
mGy/MBq
rads/mCi
mGy/MBq
rads/mCi
Thyroid
72
266
210
777
360
1300
Stomach Wall
0.45
1.7
0.46
1.7
0.46
1.7
Red Marrow
0.038
0.14
0.054
0.20
0.07
0.26
Liver
0.03
0.11
0.032
0.12
0.035
0.13
Testes
0.029
0.11
0.028
0.10
0.027
0.10
Ovaries
0.044
0.16
0.043
0.16
0.043
0.16
Urinary Bladder
0.58
2.1
0.52
1.9
0.46
1.7
Salivary Glands2
0.5
1.85
0.5
1.85
0.5
1.85
Other
0.040
0.15
0.065
0.24
0.090
0.33
2.1 Radiation Safety
Sodium Iodide I 131 Solution emits radiation and must be handled with safety measures to minimize inadvertent radiation exposure to clinical personnel and patients [see Warnings and Precautions (5.7)].
Radiopharmaceuticals should be used only by or under the direction of physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Wear waterproof gloves during the entire sodium iodide I-131 solution handling and administration procedure. Maintain adequate shielding during the radiation-emitting life of the product. Measure the patient dose using a suitable radioactivity calibration system immediately prior to administration.2.2 Hyperthyroidism
For hyperthyroidism, the usual sodium iodide I-131 dose range is 148 to 370 MBq (4 to 10 mCi). Higher doses may be necessary for the treatment of toxic nodular goiter and other special situations. Consider discontinuation of anti-thyroid therapy in a severely hyperthyroid patient three to four days before administration of sodium iodide I-131. Evaluate patients for risk of thyroid enlargement and obstruction of structures in the neck [see Warnings and Precautions (5.1, 5.2)].
2.3 Thyroid Carcinoma
For thyroid carcinoma, the usual sodium iodide I-131 therapeutic dose is 3700 to 5550 MBq (100 to 150 mCi). For ablation of post-operative residual thyroid tissue, the usual dose is 1850 MBq (50 mCi).
2.4 Individualization of Therapy
Individualize sodium iodide I-131 therapy, including dose selection, based upon patient-specific factors such as the nature of the underlying condition, co-morbidities, age, estimated thyroid tissue iodine uptake, thyroid size, as well as ability of the patient to comply with the therapeutic regimen and radiation safety procedures. Perform a clinical assessment, including history, physical examination and laboratory testing when preparing patients for sodium iodide I-131 therapy in order to detect conditions which may alter thyroid iodine uptake and increase the risks of the therapy or diminish its effectiveness. For example, intake of iodine in radiographic contrast may diminish thyroid iodine uptake while low serum chloride or nephrosis may increase thyroid iodine uptake. Obtain a drug history and ascertain whether any medications need to be withheld before the administration of the therapy [see Drug Interactions (7)].
2.5 Radiation Dosimetry
The estimated absorbed radiation doses1 to an average (70 kg) euthyroid (normal functioning thyroid) patient from an oral dose of iodine-131 in both milligray (mGy) per megabecquerel (MBq) and rad per millicurie (mCi) are shown in Table 1.
Table 1. Absorbed Radiation Doses
Tissue
Thyroid Uptake
5%
15%
25%
mGy/MBq
rads/mCi
mGy/MBq
rads/mCi
mGy/MBq
rads/mCi
Thyroid
72
266
210
777
360
1300
Stomach Wall
0.45
1.7
0.46
1.7
0.46
1.7
Red Marrow
0.038
0.14
0.054
0.20
0.07
0.26
Liver
0.03
0.11
0.032
0.12
0.035
0.13
Testes
0.029
0.11
0.028
0.10
0.027
0.10
Ovaries
0.044
0.16
0.043
0.16
0.043
0.16
Urinary Bladder
0.58
2.1
0.52
1.9
0.46
1.7
Salivary Glands2
0.5
1.85
0.5
1.85
0.5
1.85
Other
0.040
0.15
0.065
0.24
0.090
0.33
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Sodium Iodide I 131
2.1 Radiation Safety
Sodium Iodide I 131 Capsules emit radiation and must be handled with safety measures to minimize inadvertent radiation exposure to clinical personnel and patients [see Warnings and Precautions (5.7)].
Radiopharmaceuticals should be used only by or under the direction of physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Wear waterproof gloves during the entire sodium iodide I-131 capsule handling and administration procedure. Maintain adequate shielding during the radiation-emitting life of the product. Measure the patient dose using a suitable radioactivity calibration system immediately prior to administration.2.2 Hyperthyroidism
For hyperthyroidism, the usual sodium iodide I-131 dose range is 148 to 370 MBq (4 to 10 mCi). Higher doses may be necessary for the treatment of toxic nodular goiter and other special situations. Consider discontinuation of anti-thyroid therapy in a severely hyperthyroid patient three to four days before administration of sodium iodide I-131. Evaluate patients for risk of thyroid enlargement and obstruction of structures in the neck [see Warnings and Precautions (5.1, 5.2)].
2.3 Thyroid Carcinoma
For thyroid carcinoma, the usual sodium iodide I-131 therapeutic dose is 3700 to 5550 MBq (100 to 150 mCi). For ablation of post-operative residual thyroid tissue, the usual dose is 1850 MBq (50 mCi).
2.4 Individualization of Therapy
Individualize sodium iodide I-131 therapy, including dose selection, based upon patient-specific factors such as the nature of the underlying condition, co-morbidities, age, estimated thyroid tissue iodine uptake, thyroid size, as well as ability of the patient to comply with the therapeutic regimen and radiation safety procedures. Perform a clinical assessment, including history, physical examination and laboratory testing when preparing patients for sodium iodide I-131 therapy in order to detect conditions which may alter thyroid iodine uptake and increase the risks of the therapy or diminish its effectiveness. For example, intake of iodine in radiographic contrast may diminish thyroid iodine uptake while low serum chloride or nephrosis may increase thyroid iodine uptake. Obtain a drug history and ascertain whether any medications need to be withheld before the administration of the therapy [see Drug Interactions (7)].
2.5 Radiation Dosimetry
The estimated absorbed radiation doses1 to an average (70 kg) euthyroid (normal functioning thyroid) patient from an oral dose of iodine-131 in both milligray (mGy) per megabecquerel (MBq) and rad per millicurie (mCi) are shown in Table 1.
Table 1. Absorbed Radiation Doses
Tissue
Thyroid Uptake
5%
15%
25%
mGy/
MBq
rads/
mCi
mGy/
MBq
rads/
mCi
mGy/
MBq
rads/
mCi
Thyroid
72
266
210
777
360
1300
Stomach Wall
0.45
1.7
0.46
1.7
0.46
1.7
Red Marrow
0.038
0.14
0.054
0.20
0.07
0.26
Liver
0.03
0.11
0.032
0.12
0.035
0.13
Testes
0.029
0.11
0.028
0.10
0.027
0.10
Ovaries
0.044
0.16
0.043
0.16
0.043
0.16
Urinary Bladder
0.58
2.1
0.52
1.9
0.46
1.7
Salivary Glands2
0.5
1.85
0.5
1.85
0.5
1.85
Other
0.040
0.15
0.065
0.24
0.090
0.33
2.1 Radiation Safety
Sodium Iodide I 131 Capsules emit radiation and must be handled with safety measures to minimize inadvertent radiation exposure to clinical personnel and patients [see Warnings and Precautions (5.7)].
Radiopharmaceuticals should be used only by or under the direction of physicians who are qualified by training and experience in the safe use and handling of radionuclides and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Wear waterproof gloves during the entire sodium iodide I-131 capsule handling and administration procedure. Maintain adequate shielding during the radiation-emitting life of the product. Measure the patient dose using a suitable radioactivity calibration system immediately prior to administration.2.2 Hyperthyroidism
For hyperthyroidism, the usual sodium iodide I-131 dose range is 148 to 370 MBq (4 to 10 mCi). Higher doses may be necessary for the treatment of toxic nodular goiter and other special situations. Consider discontinuation of anti-thyroid therapy in a severely hyperthyroid patient three to four days before administration of sodium iodide I-131. Evaluate patients for risk of thyroid enlargement and obstruction of structures in the neck [see Warnings and Precautions (5.1, 5.2)].
2.3 Thyroid Carcinoma
For thyroid carcinoma, the usual sodium iodide I-131 therapeutic dose is 3700 to 5550 MBq (100 to 150 mCi). For ablation of post-operative residual thyroid tissue, the usual dose is 1850 MBq (50 mCi).
2.4 Individualization of Therapy
Individualize sodium iodide I-131 therapy, including dose selection, based upon patient-specific factors such as the nature of the underlying condition, co-morbidities, age, estimated thyroid tissue iodine uptake, thyroid size, as well as ability of the patient to comply with the therapeutic regimen and radiation safety procedures. Perform a clinical assessment, including history, physical examination and laboratory testing when preparing patients for sodium iodide I-131 therapy in order to detect conditions which may alter thyroid iodine uptake and increase the risks of the therapy or diminish its effectiveness. For example, intake of iodine in radiographic contrast may diminish thyroid iodine uptake while low serum chloride or nephrosis may increase thyroid iodine uptake. Obtain a drug history and ascertain whether any medications need to be withheld before the administration of the therapy [see Drug Interactions (7)].
2.5 Radiation Dosimetry
The estimated absorbed radiation doses1 to an average (70 kg) euthyroid (normal functioning thyroid) patient from an oral dose of iodine-131 in both milligray (mGy) per megabecquerel (MBq) and rad per millicurie (mCi) are shown in Table 1.
Table 1. Absorbed Radiation Doses
Tissue
Thyroid Uptake
5%
15%
25%
mGy/
MBq
rads/
mCi
mGy/
MBq
rads/
mCi
mGy/
MBq
rads/
mCi
Thyroid
72
266
210
777
360
1300
Stomach Wall
0.45
1.7
0.46
1.7
0.46
1.7
Red Marrow
0.038
0.14
0.054
0.20
0.07
0.26
Liver
0.03
0.11
0.032
0.12
0.035
0.13
Testes
0.029
0.11
0.028
0.10
0.027
0.10
Ovaries
0.044
0.16
0.043
0.16
0.043
0.16
Urinary Bladder
0.58
2.1
0.52
1.9
0.46
1.7
Salivary Glands2
0.5
1.85
0.5
1.85
0.5
1.85
Other
0.040
0.15
0.065
0.24
0.090
0.33
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Technescan Pyp
Bone and Cardiac Imaging
The recommended adult doses of Technetium Tc 99m Pyrophosphate Injection are:
Indication Doses asTechnetium Tc 99 Fraction ofVial Contents Required Skeletal Imaging 185 to 555 megabecquerels(5 to 15 mCi) 0.07 to 0.91 Cardiac Imaging 370 to 555 megabecquerels(10 to 15 mCi) 0.26 to 0.45Technetium Tc 99m Pyrophosphate Injection is injected intravenously over a 10- to 20-second period. For optimal results, bone imaging should be done one to six hours following administration. Cardiac imaging should be done 60 to 90 minutes following administration. The acute myocardial infarct can be visualized from 24 hours to nine days following onset of symptoms, with maximum localization at 48 to 72 hours. Cardiac imaging should be done with a gamma scintillation camera. It is recommended that images be made of the anterior, left anterior oblique and left lateral projections.
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. It is also recommended that the radiochemical purity be checked prior to administration.
Blood Pool Imaging
The recommended adult dose of Technescan PYP is one-third (0.33) to the entire vial contents, followed by 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate Tc 99m. 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.
In Vivo Method: Technescan PYP is reconstituted with sterile, non-pyrogenic normal saline containing no preservatives. The patient dose is administered intravenously 15 to 30 minutes prior to the intravenous administration of 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate Tc 99m. Technescan PYP should be injected by direct venipuncture. Heparinized catheter systems should be avoided.
Modified In Vivo/In Vitro Method Using Acid-Citrate-Dextrose (ACD): Technescan PYP is reconstituted with sterile, non-pyrogenic normal saline containing no preservatives, and the patient dose is administered intravenously. An intravenous line containing a 3-way stopcock is inserted in a large peripheral vein and kept patent with a continuous drip of sterile, non-pyrogenic normal saline containing no preservatives. Thirty minutes after Technescan PYP injection, the infusion line and stopcock are cleared by withdrawing and discarding approximately 5 milliliters of whole blood. Immediately following, approximately 5 milliliters of whole blood are withdrawn into a syringe containing 1 milliliter preservative-free acid-citrate-dextrose (ACD) and 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate Tc 99m. The stopcock is then turned, residual blood is flushed from the intravenous line, and the normal saline flow is readjusted. 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.
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. An infusion set fitted with a 3-way stopcock is placed in a large peripheral vein, and the intravenous line is heparinized with a saline solution containing 5 to 10 units preservative-free heparin per milliliter. Thirty minutes after Technescan PYP injection, 3 milliliters of blood are withdrawn into a syringe containing 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate Tc 99m. Anticoagulation of the blood is provided by residual heparin in the intravenous line. 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.
Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if contents are turbid.
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Technescan Mag3
The suggested dose range employed in the average adult patient (70 kg) for renal function and imaging studies is 185 MBq (5 mCi) to 370 MBq (10 mCi). In pediatric patients the recommended dose range is 2.6 MBq/kg (70 μCi/kg) to 5.2 MBq/kg (140 μCi/kg) with a minimum dose of 37 MBq (1 mCi).
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
Aseptic procedures and a shielded syringe should be employed in withdrawing doses for administration to patients. The user should wear waterproof gloves during the administration procedure.
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Technescan Hdp
General Instructions
The recommended adult dose of Technetium Tc 99m-labeled Technescan HDP is 555 MBq (15 mCi) with a range of 370 to 740 MBq (10 to 20 mCi). The recommended pediatric dose is 7.4 MBq (0.20 mCi)/kg with a range of 7.4 to 13 MBq (0.20 to 0.35 mCi)/kg. The recommended minimum total pediatric dose is 37 MBq (1.0 mCi). The maximum total dose injected into a pediatric or adult patient is 740 MBq (20.0 mCi). The maximum dose of oxidronate sodium should not exceed 2 mg.
Unit dose preparation instructions should be followed for pediatric patients. The radioactivity of each dose should be measured by a suitable radiation calibration system just prior to administration. The dose should be given intravenously by slow injection. For optimal results imaging should be performed 1 to 4 hours post-injection.
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Tolnaftate
For Myocardial Imaging: The suggested dose range for I.V. administration of Technetium Tc 99m Sestamibi in a single dose to be employed in the average patient (70 Kg) is 370–1110 MBq (10–30 mCi).
For Breast Imaging: The recommended dose range for I.V. administration of Technetium Tc 99m Sestamibi is a single dose of 740–1110 MBq (20–30 mCi).
2.1 Image Acquisition
Breast Imaging: It is recommended that images are obtained with a table overlay to separate breast tissue from the myocardium and liver, and to exclude potential activity that may be present in the opposite breast. For lateral images, position the patient prone with the isolateral arm comfortably above the head, shoulders flat against the table, head turned to the side and relaxed, with the breast imaged pendent through an overlay cutout. The breast should not be compressed on the overlay. For anterior images, position the patient supine with both arms behind the head. For either lateral or anterior images, shield the chest and abdominal organs, or remove them from the field of view.
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:
ten-minute lateral image of breast with abnormality ten-minute lateral image of contralateral breast ten-minute anterior image of both breasts2.2 Radiation Dosimetry
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.
Table 1. Radiation Absorbed Doses from Tc 99m SestamibiRadiation dosimetry calculations performed by Radiation Internal Dose Information Center, Oak Ridge Institute for Science and Education, PO Box 117, Oak Ridge, TN 37831-0117, (865) 576-3448.
Estimated Radiation Absorbed Dose REST 2.0 hour void 4.8 hour void Organ rads/30 mCi mGy/1110 MBq rads/30 mCi mGy/1110 MBq Breasts 0.2 2.0 0.2 1.9 Gallbladder Wall 2.0 20.0 2.0 20.0 Small Intestine 3.0 30.0 3.0 30.0 Upper LargeIntestine Wall 5.4 55.5 5.4 55.5 Lower LargeIntestine Wall 3.9 40.0 4.2 41.1 Stomach Wall 0.6 6.1 0.6 5.8 Heart Wall 0.5 5.1 0.5 4.9 Kidneys 2.0 20.0 2.0 20.0 Liver 0.6 5.8 0.6 5.7 Lungs 0.3 2.8 0.3 2.7 Bone Surfaces 0.7 6.8 0.7 6.4 Thyroid 0.7 7.0 0.7 2.4 Ovaries 1.5 15.5 1.6 15.5 Testes 0.3 3.4 0.4 3.9 Red Marrow 0.5 5.1 0.5 5.0 Urinary Bladder Wall 2.0 20.0 4.2 41.1 Total Body 0.5 4.8 0.5 4.8 Estimated Radiation Absorbed Dose STRESS 2.0 hour void 4.8 hour void Organ rads/30 mCi mGy/1110 MBq rads/30 mCi mGy/1110 MBq Breasts 0.2 2.0 0.2 1.8 Gallbladder Wall 2.8 28.9 2.8 27.8 Small Intestine 2.4 24.4 2.4 24.4 Upper LargeIntestine Wall 4.5 44.4 4.5 44.4 Lower LargeIntestine Wall 3.3 32.2 3.3 32.2 Stomach Wall 0.6 5.3 0.5 5.2 Heart Wall 0.5 5.6 0.5 5.3 Kidneys 1.7 16.7 1.7 16.7 Liver 0.4 4.2 0.4 4.1 Lungs 0.3 2.6 0.2 2.4 Bone Surfaces 0.6 6.2 0.6 6.0 Thyroid 0.3 2.7 0.2 2.4 Ovaries 1.2 12.2 1.3 13.3 Testes 0.3 3.1 0.3 3.4 Red Marrow 0.5 4.6 0.5 4.4 Urinary Bladder Wall 1.5 15.5 3.0 30.0 Total Body 0.4 4.2 0.4 4.22.3 Instructions for Preparation
Preparation of the Technetium Tc 99m Sestamibi from the Kit for the Preparation of Technetium Tc 99m Sestamibi is done by the following aseptic procedure:
Prior to adding the Sodium Pertechnetate Tc 99m Injection to the vial, inspect the vial carefully for the presence of damage, particularly cracks, and do not use the vial if found. Waterproof gloves should be worn during the preparation procedure. Remove the plastic disc from the vial and swab the top of the vial closure with alcohol to sanitize the surface. Place the vial in a suitable radiation shield with a fitted radiation cap. With a sterile shielded syringe, aseptically obtain additive-free, sterile, non-pyrogenic Sodium Pertechnetate Tc 99m Injection [925–5550 MBq, (25–150 mCi)] in approximately 1 to 3 mL. Aseptically add the Sodium Pertechnetate Tc 99m Injection to the vial in the lead shield. Without withdrawing the needle, remove an equal volume of headspace to maintain atmospheric pressure within the vial. Shake vigorously, about 5 to 10 quick upward-downward motions. Remove the vial from the lead shield and place upright in an appropriately shielded and contained boiling water bath, such that the vial is suspended above the bottom of the bath, and boil for 10 minutes. Timing for 10 minutes is begun as soon as the water begins to boil again. Do not allow the boiling water to come in contact with the aluminum crimp. Remove the vial from the water bath, place in the lead shield and allow to cool for fifteen minutes. Using proper shielding, the vial contents should be visually inspected. Use only if the solution is clear and free of particulate matter and discoloration. Assay the reaction vial using a suitable radioactivity calibration system. Record the Technetium Tc 99m concentration, total volume, assay time and date, expiration time and lot number on the radioassay information label and affix the label to the shield. Store the reaction vial containing the Technetium Tc 99m Sestamibi at 15° to 25°C (59° to 77°F) until use; at such time the product should be aseptically withdrawn. Technetium Tc 99m Sestamibi should be used within six hours of preparation. The vial contains no preservative.Note: Adherence to the above product reconstitution instructions is recommended.
Mallinckrodt Nuclear Medicine 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.
The potential for cracking and significant contamination exists whenever vials containing radioactive material are heated.
Product should be used within 6 hours after preparation.
Final product with radiochemical purity of at least 90% was used in the clinical trials that established safety and effectiveness. The radiochemical purity was determined by the following method.
2.4 Determination of Radiochemical Purity in Technetium Tc 99m Sestamibi
Obtain a Baker-Flex Aluminum Oxide coated, plastic TLC plate, #1 B-F, pre-cut to 2.5 cm x 7.5 cm. Dry the plate or plates at 100°C for 1 hour and store in a desiccator. Remove pre-dried plate from the desiccator just prior to use. Apply 1 drop of ethanol* using a 1 mL syringe with a 22–26 gauge needle, 1.5 cm from the bottom of the plate. THE SPOT SHOULD NOT BE ALLOWED TO DRY. Add 2 drops of Technetium Tc 99m Sestamibi solution, side by side on top of the ethanol* spot. Return the plate to a desiccator and allow the sample spot to dry (typically 15 minutes). The TLC tank is prepared by pouring ethanol* to a depth of 3–4 mm. Cover the tank and let it equilibrate for ~10 minutes. Develop the plate in the covered TLC tank in ethanol* for a distance of 5 cm from the point of application. Cut the TLC plate 4 cm from the bottom and measure the Tc 99m activity in each piece by appropriate radiation detector. Calculate the % Tc 99m Sestamibi as:*The ethanol used in this procedure should be 95% or greater. Absolute ethanol (99%) should remain at ≥95% ethanol content for one week after opening if stored tightly capped, in a cool dry place.
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