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THALLOUS CHLORIDE TL 201

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Overview

What is THALLOUS CHLORIDE TL 201?

Thallous Chloride Tl 201 Injection is supplied in isotonic solution as a sterile, nonpyrogenic, diagnostic radiopharmaceutical for intravenous administration. Each unit dose contains 1 mL and each milliliter contains 37 MBq (1 mCi) of Thallous Chloride Tl 201 Injection at calibration time. The pH is adjusted to 4.5-7.5 with hydrochloric acid or sodium hydroxide. It is made isotonic with 9 mg sodium chloride/mL and is preserved with 0.009 mL benzyl alcohol/mL.

Thallium Tl 201 is cyclotron produced with no carrier added. The radionuclidic composition at calibration time, expressed as percent of total activity, is not less than 98 percent Thallium Tl 201 with not more than 0.3 percent Thallium Tl 200 , not more than 1.2 percent Thallium Tl 202, not more than 0.2 percent Lead Pb 203, and not more than 0.3 percent all others.

The concentration of each radionuclidic contaminant changes with time. Therefore, it is recommended that Thallous Chloride Tl 201 Injection be administered close to calibration time to minimize the effect of higher levels of radionuclidic contaminants pre and post calibration. Graph 1 shows maximum allowable concentration of each radionuclidic contaminant as a function of time.



What does THALLOUS CHLORIDE TL 201 look like?



What are the available doses of THALLOUS CHLORIDE TL 201?

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What should I talk to my health care provider before I take THALLOUS CHLORIDE TL 201?

Sorry No records found

How should I use THALLOUS CHLORIDE TL 201?

Thallous Chloride Tl 201 may be useful in myocardial perfusion imaging for the diagnosis and localization of myocardial infarction. It may also have prognostic value regarding survival, when used in the clinically stable patient following the onset of symptoms of an acute myocardial infarction, to assess the site and size of the perfusion defect.

Thallous Chloride Tl 201 may also be useful in conjunction with exercise stress testing as an adjunct in the diagnosis of ischemic heart disease (atherosclerotic coronary artery disease) .

It is usually not possible to differentiate recent from old myocardial infarction, or to differentiate exactly between recent myocardial infarction and ischemia.

Thallous Chloride Tl 201 is indicated also for the localization of sites of parathyroid hyperactivity in patients with elevated serum calcium and parathyroid hormone levels. It may also be useful in pre-operative screening to localize extrathyroidal and mediastinal sites of parathyroid hyperactivity and for post-surgical reexamination. Thallous Chloride Tl 201 has not been adequately demonstrated to be effective for the localization of normal parathyroid glands.

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.


What interacts with THALLOUS CHLORIDE TL 201?

None known.



What are the warnings of THALLOUS CHLORIDE TL 201?

In general, diuretics should not be given concomitantly with lithium because they reduce its renal clearance and add a high risk of lithium toxicity. Read prescribing information for lithium preparations before use of such concomitant therapy.

When studying patients suspected or known to have myocardial infarction or ischemia, care should be taken to assure continuous clinical monitoring and treatment in accordance with safe, accepted procedure. Exercise stress testing should be performed only under the supervision of a qualified physician and in a laboratory equipped with appropriate resuscitation and support apparatus.

The contents of this vial are radioactive. Adequate shielding of the preparation must be maintained at all times.


What are the precautions of THALLOUS CHLORIDE TL 201?

Data are not available concerning the effect on the quality of Thallous Chloride Tl 201 Injection scans of marked alterations in blood glucose, insulin, or pH (such as is found in diabetes mellitus). Attention is directed to the fact that thallium is a potassium analog, and since the transport of potassium is affected by these factors, the possibility exists that the thallium may likewise be affected.

General

Do not use after the expiration time and date (5 days maximum after calibration time) stated on the label.

Do not use if contents are turbid.

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

Thallous Chloride Tl 201 Injection, as well as other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel. Also, care should be taken to minimize radiation exposure to patients in a manner consistent with proper patient management.

This radiopharmaceutical is licensed by the Illinois Emergency Management Agency for distribution to persons licensed pursuant to 32 Ill. Admin. Code Section 330.260(a) and Section 335, Subpart D, 335.3010 and Subpart E, 335.4010 or under equivalent licenses of an Agreement State or a Licensing State.

Radiopharmaceuticals should be used only by 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 government agency authorized to license the use of radionuclides.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate carcinogenic potential, mutagenic potential, or whether Thallous Chloride Tl 201 Injection affects fertility in males or females. Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first ten days following the onset of menses.

Pregnancy Category C

Animal reproduction studies have not been conducted with Thallous Chloride Tl 201 Injection. It is also not known whether Thallous Chloride Tl 201 Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Thallous Chloride Tl 201 Injection should be given to a pregnant woman only if clearly needed.

Nursing Mothers

It has been found that this drug is excreted in human milk during lactation. Therefore, formula feedings should be substituted for breast feedings.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 18 have not been established.

Geriatric Use

Clinical studies of Thallous Chloride TI 201 did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.


What are the side effects of THALLOUS CHLORIDE TL 201?

Adverse reactions that have been reported with the administration of Thallous Chloride Tl 201 Injection include allergic-type skin reactions, pruritus, itching, hypotension, nausea, sweating, and blurred vision.


What should I look out for while using THALLOUS CHLORIDE TL 201?

None known.

When studying patients suspected or known to have myocardial infarction or ischemia, care should be taken to assure continuous clinical monitoring and treatment in accordance with safe, accepted procedure. Exercise stress testing should be performed only under the supervision of a qualified physician and in a laboratory equipped with appropriate resuscitation and support apparatus.

The contents of this vial are radioactive. Adequate shielding of the preparation must be maintained at all times.


What might happen if I take too much THALLOUS CHLORIDE TL 201?

Sorry No Records found


How should I store and handle THALLOUS CHLORIDE TL 201?

Keep out of reach of children.Protect from light, moisture, and excessive heat.Dispense in tight, light-resistant container with child-resistant closure.Keep out of reach of children.Protect from light, moisture, and excessive heat.Dispense in tight, light-resistant container with child-resistant closure.Keep out of reach of children.Protect from light, moisture, and excessive heat.Dispense in tight, light-resistant container with child-resistant closure.Thallous Chloride Tl 201 Injection for intravenous administration is supplied as a sterile, nonpyrogenic solution containing at calibration time, 37 MBq/mL (1 mCi/mL) of Thallous Chloride Tl 201 Injection, 9 mg sodium chloride/mL and 0.009 mL of benzyl alcohol/mL. The pH is adjusted with hydrochloric acid and/or sodium hydroxide solution. Vials are available in the following quantities of radioactivity: 244.2 and 325.6 MBq, 6.6 and 8.8 mCi of Thallous Chloride Tl 201 Injection.NDC 17156-299-16 (6.6 mCi)NDC 17156-299-18 (8.8 mCi)Store in a lead shield at room temperature 15°-30°C (59°-86°F).Thallous Chloride Tl 201 Injection for intravenous administration is supplied as a sterile, nonpyrogenic solution containing at calibration time, 37 MBq/mL (1 mCi/mL) of Thallous Chloride Tl 201 Injection, 9 mg sodium chloride/mL and 0.009 mL of benzyl alcohol/mL. The pH is adjusted with hydrochloric acid and/or sodium hydroxide solution. Vials are available in the following quantities of radioactivity: 244.2 and 325.6 MBq, 6.6 and 8.8 mCi of Thallous Chloride Tl 201 Injection.NDC 17156-299-16 (6.6 mCi)NDC 17156-299-18 (8.8 mCi)Store in a lead shield at room temperature 15°-30°C (59°-86°F).Thallous Chloride Tl 201 Injection for intravenous administration is supplied as a sterile, nonpyrogenic solution containing at calibration time, 37 MBq/mL (1 mCi/mL) of Thallous Chloride Tl 201 Injection, 9 mg sodium chloride/mL and 0.009 mL of benzyl alcohol/mL. The pH is adjusted with hydrochloric acid and/or sodium hydroxide solution. Vials are available in the following quantities of radioactivity: 244.2 and 325.6 MBq, 6.6 and 8.8 mCi of Thallous Chloride Tl 201 Injection.NDC 17156-299-16 (6.6 mCi)NDC 17156-299-18 (8.8 mCi)Store in a lead shield at room temperature 15°-30°C (59°-86°F).Thallous Chloride Tl 201 Injection for intravenous administration is supplied as a sterile, nonpyrogenic solution containing at calibration time, 37 MBq/mL (1 mCi/mL) of Thallous Chloride Tl 201 Injection, 9 mg sodium chloride/mL and 0.009 mL of benzyl alcohol/mL. The pH is adjusted with hydrochloric acid and/or sodium hydroxide solution. Vials are available in the following quantities of radioactivity: 244.2 and 325.6 MBq, 6.6 and 8.8 mCi of Thallous Chloride Tl 201 Injection.NDC 17156-299-16 (6.6 mCi)NDC 17156-299-18 (8.8 mCi)Store in a lead shield at room temperature 15°-30°C (59°-86°F).


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Non-Clinical Toxicology
None known.

When studying patients suspected or known to have myocardial infarction or ischemia, care should be taken to assure continuous clinical monitoring and treatment in accordance with safe, accepted procedure. Exercise stress testing should be performed only under the supervision of a qualified physician and in a laboratory equipped with appropriate resuscitation and support apparatus.

The contents of this vial are radioactive. Adequate shielding of the preparation must be maintained at all times.

Data are not available concerning the effect on the quality of Thallous Chloride Tl 201 Injection scans of marked alterations in blood glucose, insulin, or pH (such as is found in diabetes mellitus). Attention is directed to the fact that thallium is a potassium analog, and since the transport of potassium is affected by these factors, the possibility exists that the thallium may likewise be affected.

Adverse reactions that have been reported with the administration of Thallous Chloride Tl 201 Injection include allergic-type skin reactions, pruritus, itching, hypotension, nausea, sweating, and blurred vision.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Interactions

Interactions

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