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Ultratag™ RBC Kit for the Preparation of Technetium Tc 99m-Labeled Red Blood Cells

INDICATIONS AND USAGE

Ultratag RBC Kit for the preparation of Technetium Tc 99m-Labeled Red Blood Cells are used for blood pool imaging, including cardiac first pass and gated equilibrium imaging and for detection of sites of gastrointestinal bleeding.

IMPORTANT RISK INFORMATION

WARNINGS AND PRECAUTIONS

  • It is essential that the user follow the directions carefully and adhere to strict aseptic procedures during preparation.
  • The contents of the kit are intended only for use in the preparation of technetium Tc 99m-labeled red blood cells and are NOT to be administered directly to the patient.
  • The contents of this kit are not radioactive. After sodium pertechnetate Tc 99m is added, however, adequate shielding of the final preparation must be maintained.
  • Technetium Tc 99m-labeled red blood cells must be handled with care to ensure minimum radiation exposure to the patient, consistent with proper patient management, and to ensure minimum radiation exposure to occupational workers.
  • The labeled red blood cells must be reinjected only into the patient from whom the blood was drawn.
  • Nuclear medicine procedures involving withdrawal and reinjection of blood have the potential for transmission of blood borne pathogens. Procedures should be implemented to avoid administration errors and viral contamination of personnel during blood product labeling.
  • The labeled red blood cells be administered within 30 minutes of preparation or as soon as possible thereafter.
  • Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides.

USE IN SPECIFIC POPULATIONS

  • Breastfeeding: should be discontinued because Technetium Tc 99m is excreted in human milk.
  • Safety and effectiveness in pediatric patients have not been established.

How Supplied

Distribution Direct
Expiration Kit expires 15 months from date on manufacture.
Storage Conditions Store kit at controlled room temperature 20-25ºC (68-77ºF). Syringe I should be protected from light if not stored in the kit tray.

Order Information

Description Qty Unit Size Order # 11 Digit NDC
Kit, 5 unit 1 each N068B0 00019906820

FREQUENTLY ASKED QUESTIONS

QuestionAnswer
If syringe I, syringe II or the technetium Tc-99m are not added in order, can I still use the kit?If not prepared in order, red blood cell labeling may not tag efficiently. Refer to package insert for preparation instructions.
What is the shelf life for the Ultratag RBC kit for the preparation of technetium Tc-99m-labeled red blood cells?Ultratag RBC lits have a fifteen (15) month expiration date from date of manufacture. Each product package is labeled with the specific expiration date. The kit should not be used after the expiration date stated on the package label.
Who do I contact for additional safety or usage questions?Call Mallinckrodt Product Monitoring at 800.778.7898.