THALLOUS CHLORIDE Tl 201 1 mCi/mL
thallous chloride, Tl 201 · INJECTION, SOLUTION · Curium US LLC
THALLOUS CHLORIDE Tl 201 is a injection, solution containing thallous chloride, tl 201 at 1 mCi/mL, taken intravenous. Manufactured by Curium US LLC.
Key Facts
- Brand Name
- THALLOUS CHLORIDE Tl 201
- Generic Name
- thallous chloride, Tl 201
- NDC Code (Product)
69945-120- Manufacturer
- Curium US LLC
- Strength
- 1 mCi/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA018150
- Marketing Start
- 11/04/2015
Recall History
Mallinckrodt Inc
Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 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 ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • For myocardial perfusion imaging: Planar 37 MBq to 74 MBq (1 mCi to 2 mCi) ( 2.2 ) SPECT 74 MBq to 111 MBq (2 mCi to 3 mCi) ( 2.2 ) For localization of parathyroid hyperactivity, planar or SPECT: 75 MBq to 130 MBq (2 mCi to 3.5 mCi) Administer by intravenous injection. ( 2.2 ) See full prescribing information for administration and imaging instructions and radiation dosimetry information. ( 2.3 , 2.4 ) 2.1 Radiation Safety – Drug Handling Handle Thallous Chloride Tl 201 Injection with appropriate safety measures to minimize radiation exposure [see Warnings and Precautions ( 5.3 )] . Use waterproof gloves, effective radiation shielding, and other appropriate safety measures when preparing and handling Thallous Chloride Tl 201 Injection. Radiopharmaceuticals should be used by or under the control of healthcare providers who are qualified by specific 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. 2.2 Recommended Dose Myocardial Perfusion Imaging in Adults Planar scintigraphy: 37 MBq to 74 MBq (…
Contraindications
4 CONTRAINDICATIONS None. None
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Risk Associated with Stress Testing [see Warnings and Precautions ( 5.2 )] Injection Site Reactions and Tissue Damage [see Warnings and Precautions ( 5.4 )] The following adverse reactions associated with the use of Thallous Chloride Tl 201 Injection were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Cardiovascular, respiratory, and cerebrovascular disorders: myocardial infarction, arrhythmia, hypotension, bronchoconstriction, and cerebrovascular events in patients who have undergone stress testing Gastrointestinal disorders: nausea, vomiting, and diarrhea General disorders and administration site conditions: injection site reactions (burning, pain, redness, swelling, warmth, and tissue damage with chronic ulcer formation), chills, fever, and sweating Immune system disorders: hypersens…
Frequently Asked Questions
What is THALLOUS CHLORIDE Tl 201 used for?
THALLOUS CHLORIDE Tl 201 contains thallous chloride, Tl 201. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is THALLOUS CHLORIDE Tl 201 a controlled substance?
THALLOUS CHLORIDE Tl 201 is not classified as a controlled substance by the DEA.
What is the generic name for THALLOUS CHLORIDE Tl 201?
The generic name for THALLOUS CHLORIDE Tl 201 is thallous chloride, Tl 201. There are no other listed brand versions of thallous chloride, Tl 201.
What is the NDC code for THALLOUS CHLORIDE Tl 201 1 mCi/mL?
The NDC (National Drug Code) for THALLOUS CHLORIDE Tl 201 1 mCi/mL is 69945-120, listed by Curium US LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)