Get your patient on Kit For The Preparation Of Technetium Tc99m Pyrophosphate - Technetium Tc99m Pyrophosphate injection (Technetium Tc99m Pyrophosphate)

Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection may be reconstituted with sterile, non-pyrogenic isotonic saline containing no preservatives. Administer not less than one-third nor more than the total contents of one vial 30 minutes prior to the intravenous administration of 555 to 740 megabecquerels (15-20 mCi) Sodium Pertechnetate Tc 99m Injection. The non-radioactive reconstituted Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection should be injected by direct venipuncture. Heparinized catheter systems should be avoided. Cardiac imaging should be done 10 to 30 minutes following the administration of Sodium Pertechnetate Tc 99m Injection utilizing a scintillation camera interfaced to an electrocardiographic gating device.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.

Radiation Dosimetry

Bone and Cardiac Imaging

The effective half-life was assumed to be the physical half-life for all calculated values. The estimated radiation absorbed doses to an average ADULT patient (70 kg) from an intravenous injection of a maximum of 555 megabecquerels (15 mCi) of Technetium Tc 99m Pyrophosphate Injection are shown in Table 4.

•Based on the model in MIRD Dose Estimate Report No. 13 (J Nucl Med 30:1117-1122, 1989).

Estimate calculated using phantoms of Cristy & Eckerman (Report ORNL/TM-8381/V1 & V7). Bone and marrow model of Eckerman (Aspects of dosimetry of radionuclides within the skeleton with particular emphasis on the active marrow. In Fourth International Radiopharmaceutical Dosimetry Symposium; A.T. Schlafke-Stelson and E.E. Watson eds. CONF-851113, Oak Ridge Associated Universities, Oak Ridge, TN 37831, 1986. pp 514-534.) used.

The effective dose equivalent is a quantity which may be suitable for comparing risks of different procedures in nuclear medicine, radiology, and other applications involving ionizing radiation, but should not be construed to give information about risks to individual patients and should not be applied to situations involving radiation therapy.

Blood Pool Imaging

The estimated absorbed radiation doses to an average adult patient (70 kg) from an intravenous injection of 740 megabecquerels (20 mCi) of Sodium Pertechnetate Tc 99m Injection, 30 minutes after the intravenous administration of the non-radioactive reconstituted Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection are shown in Table 5.

^a Assume 75% of the Sodium Pertechnetate Tc 99m labels red blood cells and the other 25% remains as pertechnetate. Method of calculation: MIRD Dose Estimate Report No. 8, J Nucl Med . 17: 74-77, 1976.

^b If 25% excreted with 1 hour T _b

Technetium Tc 99m decays by isomeric transition with a physical half-life of 6.02 hours.¹ The principal photon that is useful for detection and imaging studies is listed in Table 1.

¹Kocher DC: Radioactive decay data tables. DOE/TIC-11026: 108, 1981

The specific gamma ray constant for Tc 99m is 0.78 R/hr-millicurie at 1 cm. The first half-value layer is 0.017 cm of lead (Pb). A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of a 0.25 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000.

To correct for physical decay of this radionuclide, the fractions that remain at selected intervals after the time of calibration are shown in Table 3.

• Calibration time

Technetium Tc 99m Pyrophosphate Injection is prepared from Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection by the following aseptic procedure:

1. Waterproof gloves should be worn during the preparation procedure. Remove the white flip-off cap from the vial and swab the top of the vial closure with alcohol to sterilize the surface.
2. Complete the radiation label and affix to the vial. Place the vial in an appropriate radiation shield suitably labeled and identified.
3. With a sterile shielded syringe, aseptically obtain 1-10 milliliters of a suitable, oxidant free, sterile and non-pyrogenic Sodium Pertechnetate Tc 99m Injection containing no more than 3.7 gigabecquerels (100 mCi). Aseptically add the Sodium Pertechnetate Tc 99m Injection to the vial.
4. Swirl the contents of the vial for one minute and let stand for at least 10 minutes.
5. Record date and time of preparation.
6. It is recommended that the radiochemical purity of the prepared radiopharmaceutical be checked prior to patient administration.
7. Examine vial contents for particulates and discoloration prior to injection.
8. Withdrawals for administration must be made aseptically using a sterile shielded syringe and needle. Since the vials contain nitrogen to prevent oxidation of the complex, the vials should not be vented. If repeated withdrawals are made from a vial, the replacement of contents with air should be minimized.
9. Aseptically withdraw material with a sterile lead shielded syringe for use within six (6) hours of preparation. For optimal results, this time should be minimized. The vial contains no bacteriostatic preservative. Store the reconstituted vial at 20-25°C (68-77°F) [See USP]. Discard the vial six (6) hours after reconstitution.
10. The patient dose should be measured by suitable radioactivity calibration system immediately prior to administration.

The non-radioactive Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is prepared by adhering to the following aseptic procedure:

1. Remove the white flip-off cap from the vial and swab the top of the vial closure with alcohol to sterilize the surface.
2. Reconstitute the reaction vial with 3 milliliters of sterile, non-pyrogenic, isotonic saline containing no preservatives.
3. Swirl the contents of the vial for one minute and let stand for at least 10 minutes.
4. Record date and time of preparation.
5. Examine vial contents for particulates and discoloration prior to injection.
6. Withdrawals for administration must be made aseptically using a sterile syringe and needle. Since the vials contain nitrogen to prevent oxidation of the complex, the vials should not be vented. If repeated withdrawals are made from a vial, the replacement of contents with air should be minimized.
7. Aseptically withdraw the reconstituted non-radioactive Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection with a sterile syringe for use within six (6) hours of preparation. For optimal results, this time should be minimized. The vial contains no bacteriostatic preservative. Store the reconstituted vial at 20-25°C (68-77°F) [See USP]. Discard the vial six (6) hours after reconstitution.
8. Between one-third and a total vial of stannous pyrophosphate may be administered by direct venipuncture 30 minutes prior to intravenous administration of 555 to 740 megabecquerels (15-20 mCi) of Sodium Pertechnetate Tc 99m Injection. Heparinized catheter systems should not be used.
9. The patient dose of Sodium Pertechnetate Tc 99m Injection should be measured by a suitable radioactivity calibration system immediately prior to administration.

NDC # 45567-0060-1 for 5 vial kits

NDC # 45567-0060-2 for 30 vial kits

This reagent kit for preparation of a radiopharmaceutical is approved for use by persons licensed pursuant to Section 120.547, Code of Massachusetts Regulation 105, or under equivalent license of the U.S. Nuclear Regulatory Commission or an Agreement State.

Manufactured By:

Sun Pharmaceutical Industries, Inc.

Billerica, MA 01821

PL-000017

Rev 2

Feb 2025