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Label Changes for:

Thallous Chloride T1201 Injection

July 2016

Changes have been made to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

July 2016

WARNINGS AND PRECAUTIONS

Risk of Extravasation and Tissue Damage (and Tissue Damage added)
  • Addition of:  Confirm intravenous patency before injection.

ADVERSE REACTIONS

Postmarketing Experience (addition)
  • The following adverse reactions have been identified during post-approval use of Thallous Chloride Tl 201. Because these reactions are 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: Injection site reactions and extravasation of Tl-201 have been reported: burning, pain, redness, swelling, warmth, and, in one case, tissue damage with chronic ulcer formation.
     

 

August 2011 

WARNINGS

  • The vial stopper contains dry natural rubber latex and may cause allergic reactions in providers or patients who are sensitive to latex.

 

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