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Technescan™ PYP™ Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection

INDICATIONS AND USAGE

Technescan PYP Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is a skeletal imaging agent used to demonstrate areas of altered osteogenesis, and a cardiac imaging agent used as an adjunct in the diagnosis of acute myocardial infarction.

Technescan PYP is a blood pool imaging agent which may be used for gated blood pool imaging and for the detection of sites of gastrointestinal bleeding. When administered intravenously 15 to 30 minutes prior to intravenous administration of sodium pertechnetate Tc 99m for in vivo red blood cell labeling, approximately 75 percent of the injected activity remains in the blood pool. The modified in vivo/in vitro red blood cell labeling method may also be used for blood pool imaging.

IMPORTANT RISK INFORMATION

WARNINGS AND PRECAUTIONS

  • As an adjunct in the diagnosis of confirmed myocardial infarction (ECG and serum enzymes positive), the incidence of false negative images has been found to be 6 percent. False negative images can also occur if made too early in the evolutionary phase of the infarct or too late in the resolution phase. False positive images have been reported following coronary by-pass graft surgery, in unstable angina pectoris, old myocardial infarcts and in cardiac contusions.
  • Brain imaging should precede bone imaging procedures due to the potential of false negative and false positive imaging results.
  • Impairment of blood pool images in may occur in patients receiving sodium heparin for anticoagulant therapy. This is characterized by a reduction in the amount of injected radioactivity remaining in the blood pool.
  • Technescan PYP should be injected by direct venipuncture. Heparinized catheter systems should be avoided.
  • Technescan PYP should not be used more than six hours after preparation.
  • It is essential that the user follow the directions carefully and adhere to strict aseptic procedures during preparation.
  • The contents of this kit are not radioactive. However, after sodium pertechnetate Tc 99m is added, adequate shielding of the final preparation must be maintained.
  • Any sodium pertechnetate Tc 99m solution which contains an oxidizing agent is not suitable for use in the preparation of Technetium Tc 99m Pyrophosphate Injection.
  • Care should be taken to insure minimum radiation exposure to the patient, consistent with proper patient management, and to insure minimum radiation exposure to occupational workers.
  • Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides.
  • Both prior to and following administration of Technetium Tc 99m Pyrophosphate Injection, patients should be encouraged to drink fluids. Patients should void as often as possible after administration of Technetium Tc 99m Pyrophosphate Injection to minimize background interference from its accumulation in the bladder and to reduce unnecessary exposure to radiation.
  • The patient's cardiac condition should be stable before beginning the cardiac imaging procedure.

ADVERSE REACTIONS

  • Serious adverse reactions may include hypotension, fever and chills and hypersensitivity reactions such as itching and various skin rashes
  • Common adverse reactions include flushing, nausea, vomiting and dizziness.

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 6 hours from time of preparation
Shelf Life 6 months post manufacture
Storage Conditions Kit: Must be maintained in a refrigerator, 2-8°C (36-46°F) until use. The reconstituted vial should be stored at controlled room temperature, 20-25°C (68-77°F).

Order Information

Description Qty Unit Size Order # 11 Digit NDC
Kit, 5 vial 1 each N094B0 00019909420

FREQUENTLY ASKED QUESTIONS

QuestionAnswer
What is the shelf life for the Technescan PYP kit for the preparation of technetium Tc99m pyrophosphate injection? The kits have a six (6) month expiration from date of manufacture. Each product package is labeled with the specific expiration date. It should not be used after the expiration date stated on the package label.
How long after preparation can the Technescan PYP kit be used? It should not be used more than six hours after preparation.
Who do I contact for additional safety or usage questions?Call Mallinckrodt Product Monitoring at (800) 778-7898.