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  Kit For The Preparation Of Technetium Tc 99m Mebrofenin

  

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  The suggested intravenous dose range of Technetium Tc 99m Mebrofenin in the average patient (70 kg) is:

    Nonjaundiced patient: 74 - 185 MBq (2-5 mCi)   Patient with serum bilirubin   level greater than 1.5 mg/dL: 111-370 MBq (3-10 mCi)

  The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

  The patient should be in a fasting state, 4 hours is preferable. False positives (non-visualization) may result if the gallbladder has been emptied by ingestion of food.

  An interval of at least 24 hours should be allowed before repeat examination.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

   

  RADIATION DOSIMETRY

  The estimated absorbed radiation doses1,2 to organs and tissues of an average subject (70 kg) from an intravenous injection of 370 MBq (10 millicuries) of Technetium Tc 99m Mebrofenin are shown in Table 4.

  TABLE 4

  Estimated Absorbed Radiation Doses†

  Normal Subjects*

  Severely Jaundiced

  Patients**

  Tissue

  mGy/

  370 MBq

  rads/

  10 mCi

  mGy/

  370 MBq

  rads/

  10 mCi

  Total Body

  2.0

  0.2

  1.7

  0.17

  Liver

  4.7

  0.47

  8.1

  0.81

  Gallbladder Wall

  13.7

  1.37

  12.5

  1.25

  Small Intestine

  29.9

  2.99

  16.0

  1.60

  Upper Large

  Intestine Wall

  47.4

  4.74

  24.8

  2.48

  Lower Large

  Intestine Wall

  36.4

  3.64

  19.7

  1.97

  Kidney

  2.2

  0.22

  1.9

  0.19

  Urinary Bladder Wall

  2.9

  0.29

  24.2

  2.42

  Ovaries

  10.1

  1.01

  6.4

  0.64

  Testes

  0.5

  0.05

  1.1

  0.11

  Red Marrow

  3.4

  0.34

  2.5

  0.25

  †Method of Calculation:

  (1) Loberg, M.D., Buddemeyer, E.V.: Application of pharmacokinetic modeling to the radiation dosimetry of hepatobiliary agents. In Third International Radiopharmaceutical Dosimetry Symposium, FDA No. 81-8166, U.S. Department of Health and Human Services, Public Health Service, FDA, Bureau of Radiological Health, Rockville, MD, (1981) pp. 318-332.

  (2) Values for S: "S", Absorbed Dose per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No. 11 (1975).

  * Bilirubin <1.5 mg/dL

  Calculations assume that 98% of the injected activity is taken up by the liver; activity not removed in the urine in 24 hours is excreted in the intestines and no enterohepatic circulation of activity.

  ** Bilirubin >10 mg/dL (mean 21.8 mg/dL)

  Calculations assume that 66% of the injected activity is taken up by the liver; activity not removed in the urine in 24 hours is excreted in the intestines and no enterohepatic circulation of activity.

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  Kit For The Prepartion Of Technetium Tc99m Sulfur Colloid

  

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  Technetium Tc 99m Sulfur Colloid Injection emits radiation. Use procedures to minimize radiation exposure. Measure patient dose by a suitable radioactivity calibration system immediately before administration.

  2.1 Recommended Doses

  • Breast cancer or malignant melanoma setting in adults: 3.7 to 37 MBq (0.1 to 1 mCi) in volumes ranging from 0.1 to 1 mL by subcutaneous injection. • Peritoneo-venous (LeVeen) shunt setting in adults: 37 to 111 MBq (1 to 3 mCi) by intraperitoneal injection,  or 12 to 37 MBq (0.3 to 1 mCi) in a volume not to exceed 0.5 mL by percutaneous transtubal (efferent limb) injection. Patient repositioning or other measures may be used to help assure uniform mixing of the radiopharmaceutical with peritoneal fluid. • Imaging areas of functioning reticuloendothelial cells:   In adults: • liver/spleen imaging: 37 to 296 MBq (1 to 8 mCi) by intravenous injection; • bone marrow imaging: 111 to 444 MBq (3 to 12 mCi) by intravenous injection.   In pediatric patients: • liver/spleen imaging in children: 0.56 to 2.78 MBq (0.015 to 0.075 mCi) per kg of body weight (BW) by intravenous injection; • liver/spleen imaging in newborns: 7.4 to 18.5 MBq (0.20 to 0.50 mCi) by intravenous injection; • bone marrow imaging: 1.11 to 5.55 MBq (0.03 to 0.15 mCi) per kg of BW by intravenous injection. • Gastroesophageal and pulmonary aspiration imaging studies:   In adults: • gastroesophageal studies: 5.55 to 11.1 MBq (0.15 to 0.30 mCi) by oral administration; • pulmonary aspiration studies: 11.1 to 18.5 MBq (0.30 to 0.50 mCi) by oral administration.   In pediatric patients: • gastroesophageal and pulmonary aspiration studies: 3.7 to 11.1 MBq (0.10 to 0.30 mCi) by oral or nasogastric tube administration. For oral administration, combine the radiopharmaceutical with a milk feeding. For nasogastric tube administration, administer the radiopharmaceutical into the stomach then instill a normal volume of dextrose or milk feeding.

  2.2 Drug Preparation and Administration

  • The contents of the two Solution vials, the Solution A vial containing the appropriate acidic solution and the Solution B vial containing the appropriate buffer solution, are intended only for use in the preparation of the Technetium Tc 99m Sulfur Colloid Injection and are not to be directly administered to the patient. • Do not use Sodium Pertechnetate Tc 99m containing oxidants to reconstitute this kit. • The contents of the kit are not radioactive. However, after the Sodium Pertechnetate Tc 99m is added, maintain adequate shielding of the final preparation. Wear waterproof gloves during the preparation procedure. • Do not use Sodium Pertechnetate Tc 99m containing more than 10 micrograms per mL of aluminum ion because a flocculent precipitate may occur and such a precipitate may localize in the lung. • The contents of the kit are sterile and non-pyrogenic. This preparation contains no bacteriostatic preservative. Follow the directions carefully and adhere strictly to aseptic procedures during preparation.

  Prepare Technetium Tc 99m Sulfur Colloid Injection by the following aseptic procedure:

  1. Remove the dark brown plastic cap from the Sulfur Colloid multi-dose Reaction Vial and swab the top of the vial closure with alcohol to sterilize the surface. Complete the radiation label and affix to the vial. Place the vial in an appropriate lead-capped radiation shield labeled and identified. 2. With a sterile shielded syringe, aseptically obtain 1 to 3 mL of a suitable, oxidant-free sterile and non-pyrogenic Sodium Pertechnetate Tc 99m, each milliliter containing a maximum activity of 18,500 MBq (500 mCi). 3. Aseptically add the Sodium Pertechnetate Tc 99m to the vial. 4. Place a lead cover on the vial shield and dissolve the reagent by gentle swirling. 5. Just before use, remove the red cap from the Solution A vial and swab the top of the vial closure with alcohol to sterilize the surface. Using a sterile needle and syringe, aseptically withdraw 1.5 mL Solution A from the vial. Aseptically Inject 1.5mL Solution A into the multi-dose Reaction Vial and swirl again. 6. Transfer the multi-dose Reaction Vial from vial shield and place in a vigorously boiling water bath (water bath should be shielded with 1/8” to 1/4” lead) deep enough to cover the entire liquid contents of the vial. Keep the vial in the water bath for five minutes. 7. Remove the multi-dose Reaction Vial from the water bath and place in the lead shield and allow to cool for three minutes. Swab the vial closure again with an antiseptic. 8. Just before use, remove the blue cap from the Solution B vial and swab the top of the vial closure with alcohol to sterilize the surface. Using a sterile needle and syringe, aseptically withdraw 1.5 mL Solution B from the vial. Aseptically Inject 1.5 mL Solution B into the multi-dose Reaction Vial and swirl again. 9. Record time and date of preparation. 10. Allow the preparation to cool to body temperature before use. Maintain adequate shielding of the radioactive colloid preparation at all times. 11. Where appropriate, dilute the preparation with sterile Sodium Chloride Injection to bring the dosage to within the recommended range. 12. Mix the multi-dose Reaction Vial and aseptically withdraw material with a sterile shielded syringe for use within 6 hours of preparation. For optimum results this time should be minimized. The vial contains no bacteriostatic preservative. Store the reconstituted vial at 20 to 25°C (68 to77°F). Discard vial 6 hours after reconstitution. 13. Carefully agitate the shielded syringe immediately prior to administration of sulfur colloid to avoid particles aggregation and non-uniform distribution of radioactivity.

  Measure the patient dose by a suitable radioactivity calibration system immediately before administration. Check radiochemical purity before patient administration.

  Inspect Technetium Tc 99m Sulfur Colloid Injection visually for particulate matter and discoloration before administration, whenever solution and container permit. Do not administer the drug if it contains particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations.

  2.3 Radiation Dosimetry

  • Subcutaneous injection to assist in lymph node localization Table 1. Estimated Adult Absorbed Radiation Doses from Subcutaneous Administration of Technetium Tc 99m Sulfur Colloid Injection (mSv/MBq and rem/mCi)1

  Target Organ

  mSv/MBq

  rem/mCi

  Injection Site

  9.51

  35. 2

  Lymph Nodes

  0.951

  3.52

  Liver

  0.0028

  0.0104

  Spleen

  0.0017

  0.00629

  Bone Marrow

  0.0019

  0.00703

  Testes

  0.0009

  0.0033

  Ovaries

  0.00018

  0.00066

  Total Body

  0.004

  0.0148

  1Bergqvist L, Strand S-E, Persson B, et al. Dosimetry inLymphoscintigraphy of Tc 99m Antimony Sulfide Colloid,J Nucl Med, 23: 698-705, 1982.

  • Intravenous Injection

  Adult Radiation Doses

  Table 2. Estimated Adult Absorbed Radiation Doses from Technetium Tc 99m Sulfur Colloid Injection Administration (mSv/MBq and rem/mCi)2

  Diffuse Parenchymal Disease

  Target Organ

  Normal Liver

  Early to Intermediate

  Intermediate to Advanced

  mSv/MBq

  rem/mCi

  mSv/MBq

  rem/mCi

  mSv/MBq

  rem/mCi

  Liver

  0.091

  0.338

  0.058

  0.213

  0.044

  0.163

  Spleen

  0.058

  0.213

  0.074

  0.275

  0.115

  0.425

  Bone Marrow

  0.008

  0.028

  0.012

  0.045

  0.021

  0.079

  Testes

  0.0003

  0.001

  0.0005

  0.002

  0.0008

  0.003

  Ovaries

  0.0016

  0.006

  0.0022

  0.008

  0.0032

  0.012

  Total Body

  0.005

  0.019

  0.005

  0.019

  0.005

  0.018

  2Modified from Summary of Current Radiation Dose Estimates to Humans with Various Liver Conditions from 99m Tc-Sulfur Colloid, MIRD Dose Estimate Report No 3, J Nucl Med 16: 108A - 108B, 197 

  Pediatric Radiation Doses

  Table 3A. Estimated Pediatric Absorbed Radiation Doses from Technetium Tc 99m Sulfur Colloid Injection Administration of 1 MBq and 1 mCi for Liver/Spleen and Bone Marrow Imaging (in mSv/MBq and rem/mCi)3

  Age

  Body Weight

  Newborn

  3.5 kg

  1 year

  12.1 kg

  5 years

  20.3 kg

  10 years

  33.5 kg

  15 years

  55 kg

  Absorbed Dose

  Target Organ

  Liver

  mSv/MBq

  0.86

  0.38

  0.22

  0.18

  0.13

  rem/mCi

  3.2

  1.4

  0.82

  0.67

  0.49

  Spleen

  mSv/MBq

  0.76

  0.32

  0.18

  0.13

  0.09

  rem/mCi

  2.8

  1.2

  0.65

  0.49

  0.33

  Red Marrow

  mSv/MBq

  0.16

  0.05

  0.03

  0.022

  0.01

  rem/mCi

  0.58

  0.18

  0.11

  0.081

  0.036

  Ovaries

  mSv/MBq

  0.04

  0.02

  0.0103

  0.0043

  0.0022

  rem/mCi

  0.14

  0.064

  0.038

  0.016

  0.008

  Testes

  mSv/MBq

  0.011

  0.006

  0.004

  0.004

  0.001

  rem/mCi

  0.04

  0.021

  0.013

  0.014

  0.002

  Total Body

  mSv/MBq

  0.032

  0.026

  0.018

  0.012

  0.006

  rem/mCi

  0.12

  0.096

  0.066

  0.043

  0.022

  3from Age-dependent “S” values of Henrichs et al, Berlin 1982, except for the 1-year old. The 1-year old “S” values were taken from phantom work of the Metabolism and Dosimetry Group at ORNL

  Table 3B. Estimated Pediatric Maximum Absorbed Radiation Doses from Administration of the Maximum Recommended Dose for Technetium Tc 99m Sulfur Colloid Injection (mSv and rem) 3

  Age

  Body Weight

  Newborn

  3.5 kg

  1 year

  12.1 kg

  5 years

  20.3 kg

  10 years

  33.5 kg

  15 years

  55 kg

  Maximum

  Recommended Dose:

  a*

  b*

  a*

  b*

  a*

  b*

  a*

  b*

  a*

  b*

  MBq

  18.5

  22.2

  33.3

  67.3

  55.5

  114.7

  92.5

  186.1

  151.7

  307.1

  mCi

  0.5

  0.6

  0.9

  1.82

  1.5

  3.1

  2.5

  5.03

  4.1

  8.3

  Maximum Absorbed Dose from Maximum Recommended Dose Administered (mSv and rem)

  Target Organ

  Liver

  mSv

  16

  19.2

  12.6

  25.46

  12.3

  25.42

  16.7

  33.6

  20.1

  40.69

  rem

  1.6

  1.92

  1.26

  2.55

  1.23

  2.54

  1.67

  3.36

  2.01

  4.07

  Spleen

  mSv

  14

  16.8

  10.8

  21.83

  9.75

  20.15

  12.2

  24.55

  13.5

  27.33

  rem

  1.4

  1.68

  1.08

  2.18

  0.98

  2.02

  1.22

  2.45

  1.35

  2.73

  Red Marrow

  mSv

  2.9

  3.48

  1.62

  3.27

  1.65

  3.41

  2.03

  4.08

  1.48

  3

  rem

  0.29

  0.35

  0.16

  0.33

  0.17

  0.34

  0.2

  0.41

  0.15

  0.3

  Ovaries

  mSv

  0.7

  0.84

  0.58

  1.17

  0.57

  1.18

  0.4

  0.8

  0.34

  0.69

  rem

  0.07

  0.084

  0.058

  0.117

  0.057

  0.118

  0.04

  0.08

  0.034

  0.069

  Testes

  mSv

  0.2

  0.24

  0.19

  0.38

  0.2

  0.41

  0.35

  0.7

  0.09

  0.18

  rem

  0.02

  0.024

  0.019

  0.038

  0.02

  0.041

  0.035

  0.07

  0.009

  0.018

  Total Body

  mSv

  0.6

  0.72

  0.86

  1.74

  0.99

  2.05

  1.07

  2.15

  0.9

  1.82

  rem

  0.06

  0.072

  0.086

  0.174

  0.099

  0.205

  0.107

  0.215

  0.09

  0.182

  *a liver/spleen imaging

  *b bone marrow imaging

  3.from Age-dependent “S” values of Henrichs et al., Berlin 1982, except for the 1-year old. The 1-year old “S” values were taken from phantom work of the Metabolism and Dosimetry Group at ORNL

  • Oral Administration Table 4. Adult Radiation Absorbed Dose from Oral Administration of 1mCi of Technetium Tc99m Sulfur Colloid Injection (mSv/MBq and rem/mCi)

  Target Organ

  Assumed Residence Time (hr.)

  mSv/MBq

  rem/mCi

  Stomach Wall

  1.5

  0.038

  0.14

  Small Intestine

  4

  0.07

  0.26

  Upper Large Intestine Wall

  13

  0.13

  0.48

  Upper Large Intestine Wall

  24

  0.089

  0.33

  Ovaries

  -

  0.026

  0.096

  Testes

  -

  0.001

  0.005

  Total Body

  -

  0.005

  0.018

  • Intraperitoneal Injection Table 5. Adult Absorbed Radiation Dose from Intraperitoneal Injection of 3 mCi of Technetium Tc 99m Sulfur Colloid (mSv/MBq and rem/mCi)

  Target Organ

  Shunt Open

  Shunt Closed

  mSv/MBq

  rem/mCi

  mSv/MBq

  rem/mCi

  Liver

  0.092

  0.34

  0.015

  0.056

  Ovaries and Testes

  0.0003 to 0.0016

  0.0012 to 0.006

  0.015

  0.056

  Organs in the Peritoneal Cavity

  -

  -

  0.015

  0.056

  Total Body

  0.0049

  0.0180

  0.005

  0.019

  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. 

  • Other Exposure Estimates Table 6. Radiation Doses to Hospital Personnel (µSv/MBq and mrem/mCi)

  Technician

  Preparation of Drug*

  Administered Drug

  Target

  µSv/MBq

  mrem/mCi

  µSv/MBq

  mrem/mCi

  Extremity Dose

  0.016

  0.0575

  0.07

  0.25

  Whole Body Dose

  0.0007

  0.0025

  0.003

  0.0125

  *Using shielded vial and syringe

  2.4 Imaging Considerations

  Breast cancer or malignant melanoma setting in adults:

  • In clinical studies, patients received injection of Technetium Tc 99m Sulfur Colloid Injection and a concomitant blue dye tracer in order to enhance the ability to detect lymph nodes. Visual inspection was performed to identify the blue-labeled nodes and a hand held gamma counter was used to identify nodes concentrating the radiopharmaceutical. Multiple methods were used to detect the concentrated radioactivity within lymph nodes. For example, investigators used thresholds of background radioactivity to localize nodes containing a minimum of radioactive counts 3 times higher than the background or containing at least 10 fold higher counts than contiguous nodes . • In clinical studies of patients with malignant melanoma, preoperative lymphoscintigraphy was usually performed using planar imaging techniques to establish a road map of nodal basins and to facilitate intraoperative identification of lymph nodes. [see Clinical Studies (14)] • Technetium Tc 99m Sulfur Colloid Injection and other tracers may not localize all lymph nodes and the tracers may differ in their extent of lymph node localization. The lymph node localization of Technetium Tc 99m Sulfur Colloid Injection is dependent upon the underlying patency and structure of the lymphatic system, the extent of functional reticuloendothelial cells within lymph nodes and the radiopharmaceutical injection technique. Distortion of the underlying lymphatic system architecture and function by prior surgery, radiation or extensive metastatic disease may result in failure of the radiopharmaceutical and other tracers to localize lymph nodes. The use of Technetium Tc 99m Sulfur Colloid Injection is intended to supplement palpation, visual inspection and other procedures important to lymph node localization. [see Clinical Studies (14)]   Peritoneo-venous (LeVeen) shunt setting in adults: Following administration of Technetium Tc 99m Sulfur Colloid Injection into the peritoneal cavity, the radiopharmaceutical mixes with the peritoneal fluid. Clearance from the peritoneal cavity varies from insignificant, which may occur with complete shunt blockage, to very rapid clearance with subsequent transfer into the systemic circulation when the shunt is patent. Following transfer into the systemic circulation, the radiopharmaceutical concentrates within the liver (a target organ). Obtain serial images of both the shunt and liver. An adequate evaluation of the difference between total blockage of the shunt and partial blockage may not be feasible in all cases. Transperitoneal absorption of sulfur colloid into the systemic circulation may occur, but it occurs slowly. Therefore, the most definitive scintigraphic evaluation of shunt patency will generally be obtained if there is visualization of both the shunt itself and the liver and/or spleen within the first three hours post intraperitoneal injection of the radiopharmaceutical.   Imaging areas of functioning reticuloendothelial cells in liver, spleen or bone marrow: Altered biodistribution with lung and soft tissue uptake instead of reticuloendothelial system has been reported after intravenous injection. The size and physical-chemical properties of the sulfur colloid particles formed from the components of the kit may determine the biodistribution of the colloid and its uptake by the reticuloendothelial system. Diseases affecting the reticuloendothelial system may also alter the expected uptake pattern.   Gastroesophageal and pulmonary aspiration imaging studies: To facilitate the imaging of gastroesophageal reflux consider administering Sulfur Colloid by nasogastric tube.

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• Kit For The Preparation...
  

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  Kit For The Preparation Of Technetium Tc99m Pyrophosphate

  

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  After preparation with oxidant-free Sodium Pertechnetate Tc 99m Injection, the suggested dose range of Technetium Tc 99m Pyrophosphate Injection in the average ADULT patient (70 kg) is:

  Bone Imaging -185-555 megabecquerels (5-15 mCi)

  Cardiac Imaging - 370-555 megabecquerels (10-15 mCi)

  The suggested dose range of the non-radioactive reconstituted Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection in the average ADULT patient (70 kg) is:

  Blood Imaging - Administer not less that one-third nor more than the total contents of one vial

  [555-740 megabecquerels (15-20mCi) of Pertechnetate Tc 99m Injection].

   

  Bone and Cardiac Imaging

  Technetium Tc 99m Pyrophosphate Injection is injected intravenously over a 10 to 20 second period. For optimal results, bone imaging should be done 1 to 6 hours following administration. Cardiac imaging should be done 30 to 90 minutes following administration. The acute myocardial infarct can be visualized from 24 hours to 6 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.

  Blood Pool Imaging

  Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection may be reconstituted with sterile, non-pyrogenic isotonic saline containing no preservatives. Administer not less than one-third nor more than the total contents of one vial 30 minutes prior to the intravenous administration of 555 to 740 megabecquerels (15-20 mCi) Sodium Pertechnetate Tc 99m Injection. The non-radioactive reconstituted Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection should be injected by direct venipuncture. Heparinized catheter systems should be avoided. Cardiac imaging should be done 10 to 30 minutes following the administration of Sodium Pertechnetate Tc 99m Injection utilizing a scintillation camera interfaced to an electrocardiographic gating device.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

  The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

   

  Radiation Dosimetry

  Bone and Cardiac Imaging

  The effective half-life was assumed to be the physical half-life for all calculated values. The estimated radiation absorbed doses to an average ADULT patient (70 kg) from an intravenous injection of a maximum of 555 megabecquerels (15 mCi) of Technetium Tc 99m Pyrophosphate Injection are shown in Table 4.

  TABLE 4: Estimated Absorbed Radiation Doses Bone and Cardiac Imaging*

  Technetium Tc 99m Pyrophosphate Injection

  Target Organ

  mGy/555 MBq

  rads/15 mCi

  Total Body

  1.8

  0.18

  Kidneys

  3.6

  0.36

  Red Marrow

  3.5

  0.35

  Bone Surfaces

  21.1

  2.11

  Bladder Wall

  13.3

  1.33

  Testes

  1.4

  0.14

  Ovaries

  2.1

  0.21

  Effective Dose Equivalent

  3.3 mSv

  0.33 rem

  *Based on the model in MIRD Dose Estimate Report No. 13 (J Nucl Med 30:1117-1122, 1989).

  Estimate calculated using phantoms of Cristy & Eckerman (Report ORNL/TM-8381/V1 & V7). Bone and marrow model of Eckerman (Aspects of dosimetry of radionuclides within the skeleton with particular emphasis on the active marrow. In Fourth International Radiopharmaceutical Dosimetry Symposium; A.T. Schlafke-Stelson and E.E. Watson eds. CONF-851113, Oak Ridge Associated Universities, Oak Ridge, TN 37831, 1986. pp 514-534.) used.

  The effective dose equivalent is a quantity which may be suitable for comparing risks of different procedures in nuclear medicine, radiology, and other applications involving ionizing radiation, but should not be construed to give information about risks to individual patients and should not be applied to situations involving radiation therapy.

   

  Blood Pool Imaging

  The estimated absorbed radiation doses to an average adult patient (70 kg) from an intravenous injection of 740 megabecquerels (20 mCi) of Sodium Pertechnetate Tc 99m Injection, 30 minutes after the intravenous administration of the non-radioactive reconstituted Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection are shown in Table 5.

  TABLE 5: Estimated Absorbed Radiation Doses Blood Pool Imaginga

  Sodium Pertechnetate Tc 99m 30 min.

  Post Injection with Pyrophosphate

  Target Organ

  mGy/740 MBq

  rads/20 mCi

  Total Body

  3.2

  0.32

  Spleen

  3.6

  0.36

  Bladder Wallb

  24.0

  2.40

  Testes

  2.4

  0.24

  Ovaries

  4.6

  0.46

  Blood

  10.4

  1.04

  Red Marrow

  4.4

  0.44

  a Assume 75% of the Sodium Pertechnetate Tc 99m labels red blood cells and the other 25% remains as pertechnetate. Method of calculation: MIRD Dose Estimate Report No. 8, J Nucl Med. 17: 74-77, 1976.

  b If 25% excreted with 1 hour Tb

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  Kit For The Preparation Of Technetium Tc 99m Medronate

  

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  Shielding should be utilized when preparing Technetium Tc 99m Medronate Injection.

  After preparation with oxidant-free Sodium Pertechnetate Tc 99m Injection, the suggested dose range of Technetium Tc 99m Medronate Injection in the average ADULT patient (70 kg.) is:

    370-740 megabecquerels: (10-20 millicuries) given intravenously.   Imaging is optimal at 1 to 4 hours post Injection.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

  The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

  Radiation Dosimetry

  The effective half-life was assumed to be the physical half-life for all calculated values. The estimated radiation absorbed doses to an average ADULT patient (70 kg) from an intravenous injection of a maximum of 740 megabecquerels (20 millicuries) of Technetium Tc 99m Medronate Injection are shown in Table 4.

  TABLE 4 Estimated Absorbed Radiation Dose2 Technetium Tc 99m Medronate

  Organ

  (MGy/740 MBq)

  (Rads / 20 mCi)

  Total Body

  1.3

  0.13

  Bone Total

  7.0

  0.70

  Red Marrow

  5.6

  0.56

  Kidneys

  8.0

  0.80

  Liver

  0.6

  0.06

  Bladder Wall

  2 hour void

  26

  2.60

  4.8 hour void

  62

  6.20

  Ovaries

  2 hour void

  2.4

  0.24

  4.8 hour void

  3.4

  0.34

  Testes

  2 hour void

  1.6

  0.16

  4.8 hour void

  2.2

  0.22

  2Method of calculation: "S" Absorbed Dose Per Unit Cumulated Activity for Selected Radionuclides and Organs, MIRD Pamphlet No 11 (1975)

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  Kit For The Preparation Of Technetium Tc99m Disofenin

  

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  The suggested dose range for i.v. administration, to be employed in the average patient (70kg) is:

    Non-Jaundiced patient: 37 - 185 MBq (1-5 mCi)   Patient with serum bilirubin level greater than 5 mg/dL: 111-296 MBq (3-8 mCi)

  The patient dose should be measured by a suitable radioactivity calibration system immediately prior to patient administration. (If blood is drawn into the syringe, any unnecessary delay prior to injection may lead to clot formation in situ.) Do not backflush the syringe; slow injection is recommended. Radiochemical purity should be checked prior to patient administration.

  Store at controlled room temperature (20-25°C) before and after reconstitution.

  The patient should be in a fasting state; 4 hours is preferable. False positives (non-visualization) may result if the gallbladder has been emptied by ingestion of food.

  This preparation is usually administered to a patient only once. However, should a second dose be required, the interval between doses should not be less than 24 hours.

  Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

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  Kit For The Preparation Of Technetium Tc99m Sestamibi

  

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  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 Acqusition

  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 breasts

  2.2 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 Sestamibi

  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 Large Intestine Wall

  5.4

  55.5

  5.4

  55.5

  Lower Large Intestine 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

  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 Large Intestine Wall

  4.5

  44.4

  4.5

  44.4

  Lower Large Intestine 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

  4.2

  Radiation 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.

  2.3 Instructions for Preparation

  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:

  Boiling Water Bath Procedure

  a. 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. Tear off a radiation symbol and attach it to the neck of the vial.

  b. 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.

  c. Place the vial in a suitable radiation shield with a fitted radiation cap.

  d. 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.

  e. 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.

  f. Shake vigorously, about 5 to 10 quick upward-downward motions.

  g. 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.

  h. Remove the vial from the water bath, place in the lead shield and allow to cool for 15 minutes.

  i. Using proper shielding, the vial contents should be visually inspected. Use only if the solution is clear and free of particulate matter and discoloration.

  j. 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 vial shield label and affix the label to the shield.

  k. Store the reaction vial containing the Technetium Tc 99m Sestamibi at 20-25°C (68-77°F)[See USP] until use; at such time the product should be aseptically withdrawn. Technetium Tc 99m Sestamibi should be used within 6 hours of preparation. The vial contains no preservative.

    Note: Adherence to the above product reconstitution instructions is recommended.   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.   Pharmalucence Inc.’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.

  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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