Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED The Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is supplied in packages of 5 or 30 sterile, non-pyrogenic, white capped 10mL vials. Each multidose vial contains 12.0 mg sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dihydrate; pH is adjusted with hydrochloric acid to 5.3-5.7 prior to lyophilization. No bacteriostatic preservative is present. Sealed under nitrogen. Included in each 5-vial package are one package insert and 10 radiation labels. Included in each 30-vial package are one package insert and 60 radiation labels. Store the kit as packaged at 20-25°C (68-77°F) [See USP]. Store the reconstituted vials at 20-25°C (68-77°) [See USP]. Directions for use Bone and Cardiac Imaging Technetium Tc 99m Pyrophosphate Injection is prepared from Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection by the following aseptic procedure: 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. Complete the radiation label and affix to the vial. Place the vial in an appropriate radiation shield suitably labeled and identified. 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. Swirl the contents of the vial for one minute and let stand for at least 10 minutes. Record date and time of preparation. It is recommended that the radiochemical purity of the prepared radiopharmaceutical be checked prior to patient administration. Examine vial contents for particulates and discoloration prior to injection. 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. 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. The patient dose should be measured by suitable radioactivity calibration system immediately prior to administration. Blood Pool Imaging The non-radioactive Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is prepared by adhering to the following aseptic procedure: Remove the white flip-off cap from the vial and swab the top of the vial closure with alcohol to sterilize the surface. Reconstitute the reaction vial with 3 milliliters of sterile, non-pyrogenic, isotonic saline containing no preservatives. Swirl the contents of the vial for one minute and let stand for at least 10 minutes. Record date and time of preparation. Examine vial contents for particulates and discoloration prior to injection. 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. 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. 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. 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; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- VIAL CONTAINER STERILE NON-PYROGENIC DIAGNOSTIC MULTIDOSE KIT FOR THE PREPARTION OF TECHNETIUM Tc 99m PYROPHOSPHATE INJECTION Each 10mL reaction vial contains in 12.0 mg sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dehydrate; pH is adjusted to 5.3-5.7 with HCI prior to lyophilization. Sealed under nitrogen. Refer to Package Insert for directions for use and the recommended adult doses. Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000018 Rev 0.2 Mar 2020 CONTAINS NO BACTERIOSTATIC PRESERVATIVE. FOR INTRAVENOUS USE ONLY AFTER RECONSTITION WITH LABELING OXIDANT-FREE TECHENTIUM Tc 99m or ISOTONIC SALINE. . Store at 20-25°C (68-77°F) [See USP] after reconstitution and use within 6 hours. Rx Only Vial Label; Package/Label Display Panel-5 VIAL BOX Kit for the Preparation of Technetium Tc99m Pyrophosphate Injection Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 For Customer Service call: 1-800-221-7554 CONTENTS: 1 package insert, 10 radiation labels and 5 reaction vials. Each 10 mL reaction vial contains 12.0 mg sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dehydrate and 4.9 mg maximum total tin as stannous chloride deihydrate. pH is adjusted to 5.3 – 5.7 with HCI prior to lyophilization. Sealed under nitrogen. Contains no bacteriostatic preservative. For intravenous use only after reconstitution with oxidant-free Technetium Tc 99m or isotonic saline. Do not use if solution is cloudy. STORE KIT AS PACKAGED AT 20-25°C (68-77°F) [SEE USP] Store reconstituted vials at 20-25°C (68-77°F) [See USP]. Use within 6 hours after reconstitution. Refer to Package Insert for recommended adult doses. IMPORTANT: Read enclosed Package Insert for full information on preparation, use and indications. Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 For Customer Service call: 1-800-221-7554 PL-000020 Rev 0.3 Mar 2020 5 Vial Carton; Package/Label Display Panel- Radiation Label CAUTION RADIOACTIVE MATERIAL STERILE, NON-PYROGENIC, DIAGNOSTIC, MULTIDOSE TECHNETIUM Tc 99m PYROPHOSPHATE INJECTION FOR INTRAVENOUS USE Total MBq (mCi)_____Volume_____ Assay_____MBq/mL(mCi/mL) as of _____ Each 10mL reaction vial contains 12.0 mg sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dihydrate; pH is adjusted to 5.3-5.7 with HCI prior to lyophilization. Sealed under nitrogen. Contains no bacteriostatic preservative. For intravenous use only after reconstitution with oxidant-free Technetium Tc 99m. Do not use if solution is cloudy. Store reconstituted vial at 20-25°C (68-77°F) [see USP]. Use within 6 hours after labeling with Technetium Tc 99m. Refer to Package Insert for recommended adult doses. (SEE ENCLOSED PACKAGE INSERT) RX ONLY Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000019 Rev 0.2 Mar 2020 Shield Label; Package/Label Display Panel-30 Vial Box Kit for the preparation of Technetium Tc99m Pyrophosphate Injection STERILE, NON-PYROGENIC, DIAGNOSTIC, MULTIDOSE Rx only. Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 For Customer Service call: 1-800-221-7554 Sterile Diagnostic Multidose Non-Pyrogenic CONTENTS: 1 Package insert, 60 radiation labels and 30 reaction vials. Each 10 mL vial contains 12.0 mg sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dihydrate. pH is adjusted to 5.3 – 5.7 with HCI prior to lyophilization. Sealed under nitrogen. Contains no bacteriostatic preservative. For intravenous use only after reconstitution with oxidant-free Technetium Tc 99m or isotonic saline. Do not use if solution is cloudy. Store the kit as packaged AT 20-25°C (68-77°F) [See USP] Store reconstituted vials at 20-25°C (68-77°F) [See USP]. Use within 6 hours after reconstitution. Refer to Package Insert for recommended adult doses. IMPORTANT: Read enclosed Package Insert for full information on preparation, use and indications. Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000021 Rev 0.3 Mar 2020 30 Vial Carton
- HOW SUPPLIED The Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is supplied in packages of 5 or 30 sterile, non-pyrogenic, white capped 10mL vials. Each multidose vial contains 12.0 mg sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dihydrate; pH is adjusted with hydrochloric acid to 5.3-5.7 prior to lyophilization. No bacteriostatic preservative is present. Sealed under nitrogen. Included in each 5-vial package are one package insert and 10 radiation labels. Included in each 30-vial package are one package insert and 60 radiation labels. Store the kit as packaged at 20-25°C (68-77°F) [See USP]. Store the reconstituted vials at 20-25°C (68-77°) [See USP]. Directions for use Bone and Cardiac Imaging Technetium Tc 99m Pyrophosphate Injection is prepared from Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection by the following aseptic procedure: 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. Complete the radiation label and affix to the vial. Place the vial in an appropriate radiation shield suitably labeled and identified. 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. Swirl the contents of the vial for one minute and let stand for at least 10 minutes. Record date and time of preparation. It is recommended that the radiochemical purity of the prepared radiopharmaceutical be checked prior to patient administration. Examine vial contents for particulates and discoloration prior to injection. 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. 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. The patient dose should be measured by suitable radioactivity calibration system immediately prior to administration. Blood Pool Imaging The non-radioactive Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is prepared by adhering to the following aseptic procedure: Remove the white flip-off cap from the vial and swab the top of the vial closure with alcohol to sterilize the surface. Reconstitute the reaction vial with 3 milliliters of sterile, non-pyrogenic, isotonic saline containing no preservatives. Swirl the contents of the vial for one minute and let stand for at least 10 minutes. Record date and time of preparation. Examine vial contents for particulates and discoloration prior to injection. 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. 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. 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. 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
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL- VIAL CONTAINER STERILE NON-PYROGENIC DIAGNOSTIC MULTIDOSE KIT FOR THE PREPARTION OF TECHNETIUM Tc 99m PYROPHOSPHATE INJECTION Each 10mL reaction vial contains in 12.0 mg sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dehydrate; pH is adjusted to 5.3-5.7 with HCI prior to lyophilization. Sealed under nitrogen. Refer to Package Insert for directions for use and the recommended adult doses. Manufactured by: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000018 Rev 0.2 Mar 2020 CONTAINS NO BACTERIOSTATIC PRESERVATIVE. FOR INTRAVENOUS USE ONLY AFTER RECONSTITION WITH LABELING OXIDANT-FREE TECHENTIUM Tc 99m or ISOTONIC SALINE. . Store at 20-25°C (68-77°F) [See USP] after reconstitution and use within 6 hours. Rx Only Vial Label
- Package/Label Display Panel-5 VIAL BOX Kit for the Preparation of Technetium Tc99m Pyrophosphate Injection Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 For Customer Service call: 1-800-221-7554 CONTENTS: 1 package insert, 10 radiation labels and 5 reaction vials. Each 10 mL reaction vial contains 12.0 mg sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dehydrate and 4.9 mg maximum total tin as stannous chloride deihydrate. pH is adjusted to 5.3 – 5.7 with HCI prior to lyophilization. Sealed under nitrogen. Contains no bacteriostatic preservative. For intravenous use only after reconstitution with oxidant-free Technetium Tc 99m or isotonic saline. Do not use if solution is cloudy. STORE KIT AS PACKAGED AT 20-25°C (68-77°F) [SEE USP] Store reconstituted vials at 20-25°C (68-77°F) [See USP]. Use within 6 hours after reconstitution. Refer to Package Insert for recommended adult doses. IMPORTANT: Read enclosed Package Insert for full information on preparation, use and indications. Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 For Customer Service call: 1-800-221-7554 PL-000020 Rev 0.3 Mar 2020 5 Vial Carton
- Package/Label Display Panel- Radiation Label CAUTION RADIOACTIVE MATERIAL STERILE, NON-PYROGENIC, DIAGNOSTIC, MULTIDOSE TECHNETIUM Tc 99m PYROPHOSPHATE INJECTION FOR INTRAVENOUS USE Total MBq (mCi)_____Volume_____ Assay_____MBq/mL(mCi/mL) as of _____ Each 10mL reaction vial contains 12.0 mg sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dihydrate; pH is adjusted to 5.3-5.7 with HCI prior to lyophilization. Sealed under nitrogen. Contains no bacteriostatic preservative. For intravenous use only after reconstitution with oxidant-free Technetium Tc 99m. Do not use if solution is cloudy. Store reconstituted vial at 20-25°C (68-77°F) [see USP]. Use within 6 hours after labeling with Technetium Tc 99m. Refer to Package Insert for recommended adult doses. (SEE ENCLOSED PACKAGE INSERT) RX ONLY Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000019 Rev 0.2 Mar 2020 Shield Label
- Package/Label Display Panel-30 Vial Box Kit for the preparation of Technetium Tc99m Pyrophosphate Injection STERILE, NON-PYROGENIC, DIAGNOSTIC, MULTIDOSE Rx only. Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 For Customer Service call: 1-800-221-7554 Sterile Diagnostic Multidose Non-Pyrogenic CONTENTS: 1 Package insert, 60 radiation labels and 30 reaction vials. Each 10 mL vial contains 12.0 mg sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dihydrate. pH is adjusted to 5.3 – 5.7 with HCI prior to lyophilization. Sealed under nitrogen. Contains no bacteriostatic preservative. For intravenous use only after reconstitution with oxidant-free Technetium Tc 99m or isotonic saline. Do not use if solution is cloudy. Store the kit as packaged AT 20-25°C (68-77°F) [See USP] Store reconstituted vials at 20-25°C (68-77°F) [See USP]. Use within 6 hours after reconstitution. Refer to Package Insert for recommended adult doses. IMPORTANT: Read enclosed Package Insert for full information on preparation, use and indications. Manufactured By: Sun Pharmaceutical Industries, Inc. Billerica, MA 01821 PL-000021 Rev 0.3 Mar 2020 30 Vial Carton
Overview
Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection is a multidose reaction vial which contains the sterile, non-pyrogenic, non-radioactive ingredients necessary to produce Technetium Tc 99m Pyrophosphate Injection for diagnostic use by intravenous injection. Each 10 mL vial contains 12.0 mg of sodium pyrophosphate, 2.8 mg minimum stannous tin as stannous chloride dihydrate and 4.9 mg maximum total tin as stannous chloride dihydrate; pH is adjusted to 5.3-5.7 with hydrochloric acid prior to lyophilization. No bacteriostatic preservative is present. Sealed under nitrogen. The chemical names are: (1) Diphosphoric acid, Ditin (2 + ) salt; (2) Ditin (2 + ) pyrophosphate (4 - ). The structural formula is: When a solution of sterile, non-pyrogenic, oxidant-free isotonic Sodium Pertechnetate Tc 99m Injection U.S.P. is added to the vial, Technetium Tc 99m Pyrophosphate Injection is formed for intravenous injection. When a solution of sterile, non-pyrogenic, isotonic saline is added to the vial, it forms a blood pool imaging agent when Sodium Pertechnetate Tc 99m Injection is injected intravenously 30 minutes after the intravenous administration of the non-radioactive reconstituted Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection. The precise structure of Technetium Tc 99m Pyrophosphate Injection is not known at this time. Structural Formula Physical Characteristics 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. TABLE 1: Principal Radiation Emission Data Radiation Mean Percent Per Disintegration Mean Energy (keV) Gamma-2 89.07 140.5 ¹Kocher DC: Radioactive decay data tables. DOE/TIC-11026: 108, 1981 External Radiation 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. TABLE 2: Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation 0.017 0.5 0.08 10 -1 0.16 10 -2 0.25 10 -3 0.33 10 -4 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. TABLE 3: Physical Decay Chart: Tc 99m, half-life 6.02 hours Hours Fraction Remaining Hours Fraction Remaining 0* 1.000 7 0.447 1 0.891 8 0.398 2 0.794 9 0.355 3 0.708 10 0.316 4 0.631 11 0.282 5 0.562 12 0.251 6 0.501 * Calibration time
Indications & 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.
Dosage & Administration
After preparation with oxidant-free Sodium Pertechnetate Tc 99m Injection, the suggested dose range of Technetium Tc 99m Pyrophosphate Injection in the average ADULT patient (70 kg) is: Bone Imaging - 185-555 megabecquerels (5-15 mCi) Cardiac Imaging - 370-555 megabecquerels (10-15 mCi) The suggested dose range of the non-radioactive reconstituted Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection in the average ADULT patient (70 kg) is: Blood Imaging - Administer not less than one-third nor more than the total contents of one vial [555 - 740 megabecquerels (15-20mCi) of Pertechnetate Tc 99m Injection]. Bone and Cardiac Imaging Technetium Tc 99m Pyrophosphate Injection is injected intravenously over a 10 to 20 second period. For optimal results, bone imaging should be done 1 to 6 hours following administration. Cardiac imaging should be done 30 to 90 minutes following administration. The acute myocardial infarct can be visualized from 24 hours to 6 days following onset of symptoms, with maximum localization at 48 to 72 hours. Cardiac imaging should be done with a gamma scintillation camera. It is recommended that images be made of the anterior, left anterior oblique and left lateral projections. Blood Pool Imaging 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. TABLE 4: Estimated Absorbed Radiation Doses Bone and Cardiac Imaging* Technetium Tc 99m Pyrophosphate Injection Target Organ mGy/555 MBq rads/15 mCi Total Body 1.8 0.18 Kidneys 3.6 0.36 Red Marrow 3.5 0.35 Bone Surfaces 21.1 2.11 Bladder Wall 13.3 1.33 Testes 1.4 0.14 Ovaries 2.1 0.21 Effective Dose Equivalent 3.3 mSv 0.33 rem *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. TABLE 5: Estimated Absorbed Radiation Doses Blood Pool Imaging a Sodium Pertechnetate Tc 99m 30 min. Post Injection with Pyrophosphate Target Organ mGy/740 MBq rads/20 mCi Total Body 3.2 0.32 Spleen 3.6 0.36 Bladder Wall b 24.0 2.40 Testes 2.4 0.24 Ovaries 4.6 0.46 Blood 10.4 1.04 Red Marrow 4.4 0.44 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
Warnings & Precautions
WARNINGS 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 biodistribution of technetium Tc 99m pyrophosphate may be altered in the presence of high levels of certain cations (iron, calcium, and aluminum). This may result in reduced uptake of radionuclide in the skeleton and increased extraosseal uptake, which may potentially degrade imaging quality. High levels of these cations may be caused by concomitant medications or medical conditions (e.g., iron overload, hypercalcemia, etc.). Most cases were observed after iron infusion. (See PRECAUTIONS, Drug Interactions .)
Contraindications
None known.
Adverse Reactions
Some hypersensitivity reactions have been associated with pyrophosphate use.
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