Kit for the Preparation of Technetium Tc99m

Pyrophosphate Injection

For Diagnostic Use, Rx Only

Product Information and Features

  • Each 10 ml multidose reaction vial contains:
    • 12.0 mg sodium pyrophosphate
    • 2.8 mg minimum stannous tin and 4.9 mg maximum total tin as stannous chloride dihydrate
    • pH adjusted to 5.3 to 5.7
    • Contents lyophilized and sealed under nitrogen
  • High tin content for increased red cell binding capacity
  • Available in either 5 vial kits (CPYR05) and 30 vial convenience packs (CPYR30)

Indications and Usage

Technetium Tc 99m Pyrophosphate Injection is a bone 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.

Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection 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 reconstituted with sterile non-pyrogenic isotonic saline and administered intravenously 30 minutes prior to the intravenous administration of Sodium Pertechnetate Tc 99m Injection, approximately 76% of the injected radioactivity remains in the blood pool.

IMPORTANT SAFETY INFORMATION

WARNINGS AND GENERAL 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 prior to 24 hours in the evolutionary phase of the infarct or after 6 days in the resolution phase. In a limited study involving 22 patients in whom the ECG was positive and serum enzymes questionable or negative, but in whom the final diagnosis of acute myocardial infarction was made, the incidence of false negative images was 23 percent. The incidence of false positive images has been found to be 7 to 9 percent. False positive images have also been reported following coronary by-pass graft surgery, in unstable angina pectoris, old myocardial infarcts and in cardiac contusions.

Preliminary reports indicate impairment of brain scans using Sodium Pertechnetate Tc99m Injection which have been preceded by a bone scan using an agent containing stannous ions. The impairment may result in false positive or false negative brain scans. It is recommended, where feasible, that brain scans precede bone imaging procedures. Alternately, a brain imaging agent such as Technetium Tc 99m Pentetate Injection may be employed.

The lyophilized contents of the Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection reaction vial are to be administered to the patient only as an intravenous solution (see Procedures for Reconstitution). Any Sodium Pertechnetate Tc 99m solution which contains an oxidizing agent is not suitable for use with Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection. When reconstituted with Sodium Pertechnetate Tc 99m, Technetium Tc 99m Pyrophosphate Injection must be used within 6 hours. Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection may also be reconstituted with sterile, non-pyrogenic isotonic saline containing no preservatives and injected intravenously prior to the administration of Sodium Pertechnetate Tc 99m Injection.

Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection contains no preservatives.

Vials are sealed under nitrogen: air or oxygen is harmful to the contents of the vials and the vials should not be vented.

The components of the Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection are supplied sterile and non-pyrogenic. Aseptic procedures normally employed in making additions and withdrawals for sterile, non-pyrogenic containers should be used during addition of the Sodium Pertechnetate Tc 99m Injection and the withdrawal of doses for patient administration.

Shielding should be utilized when preparing Technetium Tc 99m Pyrophosphate Injection.

Technetium Tc 99m Pyrophosphate Injection as well as other radioactive drugs must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to the patients and clinical personnel consistent with proper patient management.

The solution should not be used if cloudy, discolored, or found to contain particulate matter.

Radiopharmaceuticals should be used only by physicians who are qualified by training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

No special handling is required for the non-radioactive drug product.

ADVERSE REACTIONS

Some hypersensitivity reactions have been associated with pyrophosphate use.

Please See Full Prescribing Information Above

The above information provided in this page is intended for use by professional licensed health care provider only. This information is not intended for Medical advice. Please refer to Package Insert for full Prescribing Information including the adverse reactions with the use. Technetium Tc 99m Pyrophosphate Injection as well as other radioactive drugs must be handled with care, and appropriate safety measures should be used to minimize radiation exposure to the patients and clinical personnel consistent with proper patient management.