Thallous Chloride Tl 201

Thallous Chloride Tl 201 Manufacturers

• Ge Healthcare, Medi-physics, Inc.
  

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  Thallous Chloride Tl 201 | Ge Healthcare, Medi-physics, Inc.

  

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  The recommended adult (70 kg) dose of Thallous Chloride Tl 201 Injection is 37-74 MBq (1-2 mCi). Thallous Chloride Tl 201 Injection is intended for intravenous administration only.

  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.

  Aseptic procedures should be employed in the withdrawal of the dose for patient administration.

  For resting thallium studies, imaging should begin 10-20 minutes after injection. Myocardial-to-background ratios are improved when patients are injected upright and in the fasting state; the upright position reduces the hepatic and gastric Thallium Tl 201 concentration.

  When utilized in conjunction with exercise stress testing, Thallous Chloride Tl 201 Injection should be administered at the inception of a period of maximum stress which is sustained for approximately 30 seconds after injection. Imaging should begin within 10 minutes after administration to obtain maximum target-to-background ratios. Several investigators have reported that within two hours after the completion of stress testing the target-to-background ratios may decrease significantly in lesions that are attributable to transient ischemia.

  For the localization of parathyroid hyperactivity, Thallous Chloride Tl 201 may be administered before, with or after a minimal dose of a thyroid imaging agent such as sodium pertechnetate Tc99m or sodium iodide I 123 to enable thyroid subtraction imaging.

  RADIATION DOSIMETRY

  The estimated absorbed doses at calibration time to an average patient (70 kg) from an intravenous injection of a maximum dose of 74 MBq, 2 mCi of Thallous Chloride Tl 201 Injection are shown in Table 4.

  Table 4. Radiation Dose Estimates of Thallous Chloride Tl 201 Injection: Absorbed Dose/74 MBq, 2 mCi Thallium Tl 201 Administered* Tissue mGy/74 MBq Rads/2 mCi * Values listed include an average maximum correction of 8% to the radiation doses from Thallous Chloride Tl 201 Injection due to the radiocontaminants Thallium Tl 200 and Thallium Tl 202 at calibration time. Heart Wall 10.0 1.0   Liver 12.0 1.2   Kidneys 24.0 2.4   Testes 11.0 1.1   Ovaries   9.6 0.96 Thyroid   9.6 0.96 Gastrointestinal Tract:   Stomach Wall   8.2 0.82   Small Intestine   7.8 0.78   Upper Large Intestine Wall   5.2 0.52   Lower Large Intestine Wall   4.4 0.44 Total Body   4.4 0.44

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• Lantheus Medical Imaging, Inc.
  

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  Thallous Chloride Tl 201 | Lantheus Medical Imaging, Inc.

  

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  DOSAGE AND ADMINISTRATION: The recommended adult dose of intravenous Thallous Chloride Tl 201 Injection for planar myocardial imaging is 37 to 74 MBq (1-2 mCi). The recommended intravenous doses for SPECT myocardial imaging are 74 to 111 MBq (2-3 mCi). The efficacy of a 1.0 mCi dose SPECT imaging has not been well established.

  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.

  For patients undergoing resting thallium studies, imaging is optimally begun within 10-20 minutes after injection. Several investigators have reported improved myocardial-to-background ratios when patients are injected in the fasting state, in an upright posture, or after briefly ambulating. The upright position reduces the hepatic and gastric Thallium TI 201 concentration.

  Best results with thallium imaging performed in conjunction with exercise stress testing appear to be obtained if the thallium is administered when the patient reaches maximum stress and when the stress is continued for 30 seconds to one minute after injection. Imaging should begin within ten minutes post-injection since target-to-background ratio is optimum by that time. Several investigators have reported significant decreases in the target-to-background ratios of lesions attributable to transient ischemia by two hours after the completion of stress Imaging.

  For the localization of parathyroid hyperactivity, Thallous Chloride Tl 201 Injection may be administered before, with or after a minimal dose of a thyroid imaging agent such as sodium pertechnetate Tc99m or sodium iodide I 123 to enable thyroid subtraction imaging.

  RADIATION DOSIMETRY Table 4 Radiation Dose Estimates for Thallous Chloride Tl 201 Injection (plus contaminants) Estimate Radiation Dose Organ MGy/MBq Rad/mCi Adrenals .065 0.24 Brain .061 0.22 Breasts .036 0.13 GB Wall .084 0.31 LLI Wall .34 1.3 Small Intestine .45 1.7 Stomach .19 0.69 ULI .33 1.2 Heart Wall .28 1.0 Kidneys .46 1.7 Liver .099 0.37 Lungs .048 0.18 Muscle .047 0.17 Ovaries .10 0.38 Pancreas .075 0.28 Marrow .056 0.21 Bone Surfaces .089 0.33 Skin .034 0.13 Spleen .18 0.66 Testes .83 3.1 Thymus .047 0.17 Thyroid .62 2.3 Urinary Bladder wall .053 0.20 Uterus .086 0.32 Effective Dose Equiv. .36 mSv/MBq 1.3 rem/mCi

  Based on data gathered in humans by Krahwinkel et al. (J Nucl Med 29(9):1582-1586, 1988) and data gathered in humans by Gupta et al. (Int J Nucl Med & Biol 8:211-213, 1981).

  Bladder voiding interval 4.8hr. Contaminants assumed: TI-200 (0.3%), TI-202 (0.84%), Pb-203 (0.2%). Includes dose from TI-201 Auger electrons. Estimate calculated using phantom of Cristy & Eckerman (Report ORNL/TM-8381/V1 & V7). Radiation Internal Dose Information Center.

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• Mallinckrodt Inc.
  

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  Thallous Chloride Tl 201 | Mallinckrodt Inc.

  

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  2.1 Radiation Safety

  Thallous Chloride Tl 201 Injection emits radiation and must be handled with appropriate safety measures and in accordance with the “as low as reasonably achievable” (ALARA) principle of radioactivity dosing.

  Use the lowest dose of Thallous Chloride Tl 201 Injection necessary to obtain the intended diagnostic image. Individualize the dose and consider factors such as body size, and the equipment and technique to be employed. 

  2.2 Recommended Dose

  Myocardial perfusion

  Planar scintigraphy: 37 to 74 MBq (1 to 2 mCi) administered intravenously SPECT: 74 to 111 MBq (2 to 3 mCi) administered intravenously

  Parathyroid hyperactivity localization

  Planar or SPECT: 75 to 130 MBq (2 to 3.5 mCi) administered intravenously

  2.3 Drug Administration and Imaging

  For resting myocardial studies, begin imaging 10 to 20 minutes after injection of Thallous Chloride Tl 201. Myocardial-to-background ratios are improved when patients are injected upright and in the fasting state; the upright position reduces the hepatic and gastric Thallium Tl 201 concentration.

  For exercise stress testing administer Thallous Chloride Tl 201 Injection at the start of a period of maximum stress which is sustained for approximately
  30 seconds after injection. Begin imaging within ten minutes after administration to obtain maximum target-to-background ratios. Within two hours after the completion of the stress testing the target-to-background ratios may decrease in lesions that are attributable to transient ischemia.

  For localization of parathyroid hyperactivity, administer Thallous Chloride
  Tl 201 Injection before, with or after a minimal dose of a thyroid imaging agent such as sodium pertechnetate Tc 99m or sodium iodide I 123 to enable thyroid subtraction imaging. 

  2.4 Radiation Dosimetry

  The estimated absorbed radiation doses at calibration time to a 70 kg patient from an intravenous injection of Thallous Chloride Tl 201 are shown in Table 1. The estimates were calculated based on human data from Krahwinkel et al.1 and Thomas et al.2 Assumed percentages of 98.3% 201Tl, 0.3% 200Tl, 1.2% 202Tl, and 0.2% 203Pb. The effective dose was calculated using ICRP 103 tissue weighting factors and assumptions on the biodistribution data based on data from Krahwinkel et al. and Thomas et al.

  Table 1. Radiation Dose Estimates for Thallous Chloride Tl 201  (includes contaminants)

  Organ

  Estimated Radiation Dose

  mGy/MBq

  rad/mCi

  Adrenals

  6.33E-02

  2.34E-01

  Brain

  5.68E-02

  2.10E-01

  Breasts

  3.39E-02

  1.25E-01

  GB Wall  

  8.31E-02

  3.07E-01

  LLI Wall

  2.96E-01

  1.09E+00

  Small Intestine

  3.79E-01

  1.40E+00

  Stomach

  1.71E-01

  6.34E-01

  ULI Wall

  2.97E-01

  1.10E+00

  Heart Wall

  2.47E-01

  9.14E-01

  Kidneys

  4.10E-01

  1.52E+00

  Liver

  9.39E-02

  3.47E-01

  Lungs

  4.73E-02

  1.75E-01

  Muscle

  4.59E-02

  1.70E-01

  Ovaries

  1.02E-01

  3.76E-01

  Pancreas

  7.52E-02

  2.78E-01

  Red Marrow

  4.44E-02

  1.64E-01

  Bone Surfaces

  9.37E-02

  3.47E-01

  Skin

  3.16E-02

  1.17E-01

  Spleen

  1.66E-01

  6.14E-01

  Testes 

  2.09E-01

  7.73E-01

  Thymus

  4.60E-02

  1.70E-01

  Thyroid

  5.42E-01

  2.00E+00

  Urinary Bladder Wall   

  6.25E-02

  2.31E-01

  Uterus

  8.63E-02

  3.19E-01

  Total Body

  5.77E-02

  2.14E-01

  Effective Dose

  0.145mSv/MBq

  0.535rem/mCi

  1 Krahwinkel W, Herzog H, Feinendegen LE. Pharmacokinetics of
  thallium-201 in normal individuals after routine myocardial scintigraphy.
  J Nucl Med, 1988; 29, 1582–1586. 2 Thomas SR, Stabin MG, Castronovo FP. Radiation-absorbed dose from
  201Tl-thallous chloride . J Nucl Med, 2005; 46(3), 502-508. 2.5 Drug Handling Do not use this drug after six (6) days from the calibration date, or nine (9) days from date of manufacture, whichever comes first. Limit the use of this drug, to physicians who are qualified by training and experience in the safe use and handling of radionuclides. Wear waterproof gloves during the handling procedures. Aseptically withdraw the material for use with a shielded sterile syringe. Measure the patient dose with a suitable radioactivity calibration system immediately prior to administration. Visually inspect the drug for particulate matter and discoloration prior to administration, whenever solution and container permit.  Do not use if contents are turbid. Minimize radiation exposure to the patient and insure minimum radiation exposure to occupational workers.
    2.1 Radiation Safety

  Thallous Chloride Tl 201 Injection emits radiation and must be handled with appropriate safety measures and in accordance with the “as low as reasonably achievable” (ALARA) principle of radioactivity dosing.

  Use the lowest dose of Thallous Chloride Tl 201 Injection necessary to obtain the intended diagnostic image. Individualize the dose and consider factors such as body size, and the equipment and technique to be employed. 

  2.2 Recommended Dose

  Myocardial perfusion

  Planar scintigraphy: 37 to 74 MBq (1 to 2 mCi) administered intravenously SPECT: 74 to 111 MBq (2 to 3 mCi) administered intravenously

  Parathyroid hyperactivity localization

  Planar or SPECT: 75 to 130 MBq (2 to 3.5 mCi) administered intravenously

  2.3 Drug Administration and Imaging

  For resting myocardial studies, begin imaging 10 to 20 minutes after injection of Thallous Chloride Tl 201. Myocardial-to-background ratios are improved when patients are injected upright and in the fasting state; the upright position reduces the hepatic and gastric Thallium Tl 201 concentration.

  For exercise stress testing administer Thallous Chloride Tl 201 Injection at the start of a period of maximum stress which is sustained for approximately
  30 seconds after injection. Begin imaging within ten minutes after administration to obtain maximum target-to-background ratios. Within two hours after the completion of the stress testing the target-to-background ratios may decrease in lesions that are attributable to transient ischemia.

  For localization of parathyroid hyperactivity, administer Thallous Chloride
  Tl 201 Injection before, with or after a minimal dose of a thyroid imaging agent such as sodium pertechnetate Tc 99m or sodium iodide I 123 to enable thyroid subtraction imaging. 

  2.4 Radiation Dosimetry

  The estimated absorbed radiation doses at calibration time to a 70 kg patient from an intravenous injection of Thallous Chloride Tl 201 are shown in Table 1. The estimates were calculated based on human data from Krahwinkel et al.1 and Thomas et al.2 Assumed percentages of 98.3% 201Tl, 0.3% 200Tl, 1.2% 202Tl, and 0.2% 203Pb. The effective dose was calculated using ICRP 103 tissue weighting factors and assumptions on the biodistribution data based on data from Krahwinkel et al. and Thomas et al.

  Table 1. Radiation Dose Estimates for Thallous Chloride Tl 201  (includes contaminants)

  Organ

  Estimated Radiation Dose

  mGy/MBq

  rad/mCi

  Adrenals

  6.33E-02

  2.34E-01

  Brain

  5.68E-02

  2.10E-01

  Breasts

  3.39E-02

  1.25E-01

  GB Wall  

  8.31E-02

  3.07E-01

  LLI Wall

  2.96E-01

  1.09E+00

  Small Intestine

  3.79E-01

  1.40E+00

  Stomach

  1.71E-01

  6.34E-01

  ULI Wall

  2.97E-01

  1.10E+00

  Heart Wall

  2.47E-01

  9.14E-01

  Kidneys

  4.10E-01

  1.52E+00

  Liver

  9.39E-02

  3.47E-01

  Lungs

  4.73E-02

  1.75E-01

  Muscle

  4.59E-02

  1.70E-01

  Ovaries

  1.02E-01

  3.76E-01

  Pancreas

  7.52E-02

  2.78E-01

  Red Marrow

  4.44E-02

  1.64E-01

  Bone Surfaces

  9.37E-02

  3.47E-01

  Skin

  3.16E-02

  1.17E-01

  Spleen

  1.66E-01

  6.14E-01

  Testes 

  2.09E-01

  7.73E-01

  Thymus

  4.60E-02

  1.70E-01

  Thyroid

  5.42E-01

  2.00E+00

  Urinary Bladder Wall   

  6.25E-02

  2.31E-01

  Uterus

  8.63E-02

  3.19E-01

  Total Body

  5.77E-02

  2.14E-01

  Effective Dose

  0.145mSv/MBq

  0.535rem/mCi

  1 Krahwinkel W, Herzog H, Feinendegen LE. Pharmacokinetics of
  thallium-201 in normal individuals after routine myocardial scintigraphy.
  J Nucl Med, 1988; 29, 1582–1586. 2 Thomas SR, Stabin MG, Castronovo FP. Radiation-absorbed dose from
  201Tl-thallous chloride . J Nucl Med, 2005; 46(3), 502-508. 2.5 Drug Handling Do not use this drug after six (6) days from the calibration date, or nine (9) days from date of manufacture, whichever comes first. Limit the use of this drug, to physicians who are qualified by training and experience in the safe use and handling of radionuclides. Wear waterproof gloves during the handling procedures. Aseptically withdraw the material for use with a shielded sterile syringe. Measure the patient dose with a suitable radioactivity calibration system immediately prior to administration. Visually inspect the drug for particulate matter and discoloration prior to administration, whenever solution and container permit.  Do not use if contents are turbid. Minimize radiation exposure to the patient and insure minimum radiation exposure to occupational workers.
   

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