Thallous chloride tl-201

Thallous Chloride Tl 201 Injection is indicated for use with planar scintigraphy or single-photon emission computed tomography (SPECT) for the following applications: Myocardial perfusion imaging in adults for the diagnosis of coronary artery disease by localization of: Non-reversible defects (myocardial infarction) Reversible defects (myocardial ischemia) when used in conjunction with exercise or pharmacologic stress Localization of sites of parathyroid hyperactivity pre- and post-operatively in adults with elevated serum calcium and parathyroid hormone levels Thallous Chloride Tl 201 Injection is a radioactive diagnostic drug indicated for use with planar scintigraphy or single-photon emission computed tomography (SPECT) for: Myocardial perfusion imaging in adults for the diagnosis of coronary artery disease by localization of: Non-reversible defects (myocardial infarction) Reversible…

Thallous chloride Tl 201 with no carrier added accumulates in viable myocardium in a manner analogous to that of potassium. Experiments in healthy subjects using labeled microspheres have shown that the myocardial distribution of thallous chloride Tl 201 correlates with regional perfusion. In clinical studies, Thallous Chloride Tl 201 images have been found to visualize areas of infarction as “cold” or nonlabeled regions that were confirmed by electrocardiographic and enzyme changes. Regions of transient myocardial ischemia corresponding to areas perfused by coronary arteries with partial stenoses have been visualized when Thallous Chloride Tl 201 Injection was administered in conjunction with an exercise stress test. Anatomic configurations may interfere with visualization of the right coronary artery territory.

• For myocardial perfusion imaging: Planar 37 MBq to 74 MBq (1 mCi to 2 mCi). SPECT 74 MBq to 111 MBq (2 mCi to 3 mCi). For localization of parathyroid hyperactivity, planar or SPECT: 75 MBq to 130 MBq (2 mCi to 3.5 mCi) Administer by intravenous injection. See full prescribing information for administration and imaging instructions and radiation dosimetry information.

None. None

Hypersensitivity Reactions: Anaphylactic reactions characterized by cardiovascular, respiratory, and cutaneous symptoms may occur. Have resuscitation equipment and trained staff readily available. Risk Associated with Stress Testing: Induction of cardiovascular stress may be associated with serious adverse reactions. Perform stress testing in a setting where cardiac resuscitation equipment and trained staff are readily available. Radiation Risk: Ensure safe handling to minimize radiation exposure to patients and health care providers.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions Risk Associated with Stress Testing Injection Site Reactions and Tissue Damage The following adverse reactions associated with the use of Thallous Chloride Tl 201 Injection were identified in clinical studies or postmarketing reports.

Store Thallous Chloride Tl 201 Injection in the original container with radiation shielding at 20°C to 25°C (68°F to 77°F).