Canada Spect Products | Cardiology

Ultratag™ RBC

(kit for the preparation of technetium Tc 99m-labeled red blood cells)

Queste informazioni sono ad uso esclusivo di professionisti nel settore sanitario canadese.

INFORMAZIONI DI PRODOTTO

Efficient
The only Health Canada approved in vitro red blood cell Tc 99m labelling agent with typical tagging efficiency of ≥95%.1

Consistent
Consistently high labelling yields, even in the presence of certain medications.2

Confident
Excellent target-to-background ratio1 from in vitro labelling helps in obtaining quality images.3,4

Indicazione e utilizzo

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.

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 Ultratag™ RBC (kit for 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.
  • Ultratag™ RBC (kit for the preparation of 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 Ultratag™ RBC (kit for the preparation of technetium Tc 99m-labeled red blood cells) is excreted in human milk.
  • Safety and effectiveness in pediatric patients have not been established.

Frequently asked questions

Add 370 to 3700 MBq (10 to 100 mCi) sodium pertechnetate Tc 99m (in a volume of up to 3 mL) to the reaction vial, see package insert for additional details.

Safety and efficacy in pediatric patients have not been established.

It is recommended that the labeled red blood cells be administered within 30 minutes of preparation or as soon as possible thereafter. A small study showed that technetium Tc 99m-labeled red blood cells prepared with Ultratag™ RBC have equivalent in vivo labeling efficiency when administered both immediately after preparation (5 patients studied) and at 6 hours after preparation (6 patients studied) with a 24-hour labeling efficiency averaging 97% for both groups.

Ultratag™ RBC can be ordered through Canada Customer Service at Canada Customer Service at 866.885.5988.  Orders are accepted Monday-Friday, 8:00 am through 5:00 pm. EST.

All order changes or cancellations are handled through the Canada Customer Service team at 866.885.5988. Please call a Customer Service Representative for specific information regarding ordering and cancellation of orders.  Order cut off times and cancellation times vary by product.

Call Curium Product Monitoring at 866.789.2211

How is this product supplied

Distribution

Direct

Expiration

Ultratag™ RBC consists of three separate nonradioactive components. The expiration date of the kit reflects the earliest component expiration date.

Storage conditions

Controlled room temperature 20° to 25°C (68° to 77°F)

Order information

Descriptions Qty Uni Size Order # NDC
Ultratag, kit 5 vial 1 Kit – 068B0CA 69945-068-20

References

1Ultratag™ RBC package insert. Curium Canada Inc. Laval, QC, H7T-2R3 CANADA; 2019.
2 Spicer JA, Hladik WB III, Mulberry WE. The effects of selected antineoplastic agents on the labelling of erythrocytes with technetium-99m using the Ultratag RBC kit. J Nucl Med Technol. 1999;27:132-135.
3 Patrick ST, Glowniak JV, Turner FE. Comparison of in vitro RBC labelling with the Ultratag™ RBC kit versus in vivo labelling. J Nucl Med. February 1991;32:242-244.
4 Taylor A, Schuster DM, Alazraki N. A Clinician’s Guide to Nuclear Medicine. 2nd ed. Society of Nuclear Medicine, Inc. 2006;12.

Product contact information

Canada

N/A