Kit For The Preparation Of Tc 99m Pyrophosphate
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Questions & Answers
Side Effects & Adverse Reactions
Reports indicate impairment of brain images using sodium pertechnetate Tc 99m, which have been preceded by a bone image. The impairment may result in false positives or false negatives. It is recommended, where feasible, that brain imaging precede bone imaging procedures.
Preliminary reports indicate impairment of blood pool images 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
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. 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 been reported following coronary by-pass graft surgery, in unstable angina pectoris, old myocardial infarcts and in cardiac contusions.
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.
History
There is currently no drug history available for this drug.
Other Information
TechneScan™ PYP™ (kit for the preparation of Technetium Tc 99m Pyrophosphate Injection) is a sterile, non-pyrogenic, diagnostic radiopharmaceutical suitable for intravenous administration after reconstitution with sterile sodium pertechnetate Tc 99m injection or sterile 0.9% sodium chloride injection.
Each 10 milliliter reaction vial contains 11.9 milligrams sodium pyrophosphate, 3.2 milligrams (minimum) stannous chloride (SnCl2•2H2O) and 4.4 milligrams (maximum) total tin expressed as stannous chloride (SnCl2•2H2O) in lyophilized form under an atmosphere of nitrogen. Prior to lyophilization the pH is adjusted with hydrochloric acid. The pH of the reconstituted drug is between 4.5 and 7.5. No bacteriostatic preservative is present.
The precise structures of the stannous-pyrophosphate and technetium-stannous-pyrophosphate complexes are not known at this time.
Sources
Kit For The Preparation Of Tc 99m Pyrophosphate Manufacturers
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Mallinckrodt Inc.
![Kit For The Preparation Of Tc 99m Pyrophosphate (Technescan Pyp) Injection, Powder, Lyophilized, For Solution [Mallinckrodt Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Kit For The Preparation Of Tc 99m Pyrophosphate | Mallinckrodt Inc.
Bone and Cardiac ImagingThe recommended adult doses of Technetium Tc 99m Pyrophosphate Injection are:
Indication Doses as
Technetium Tc 99 Fraction of
Vial Contents Required Skeletal Imaging 185 to 555 megabecquerels
(5 to 15 mCi) 0.07 to 0.91 Cardiac Imaging 370 to 555 megabecquerels
(10 to 15 mCi) 0.26 to 0.45Technetium Tc 99m Pyrophosphate Injection is injected intravenously over a 10- to 20-second period. For optimal results, bone imaging should be done one to six hours following administration. Cardiac imaging should be done 60 to 90 minutes following administration. The acute myocardial infarct can be visualized from 24 hours to nine 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.
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. It is also recommended that the radiochemical purity be checked prior to administration.
Blood Pool ImagingThe recommended adult dose of TechneScan PYP is one-third (0.33) to the entire vial contents, followed by 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate Tc 99m. Cardiac imaging should be done 10 minutes following the administration of sodium pertechnetate Tc 99m (in vivo method) or Tc 99m labeled red blood cells (modified in vivo/in vitro method) utilizing a scintillation camera interfaced to an electrocardiographic gating device.
In Vivo Method: TechneScan PYP is reconstituted with sterile, non-pyrogenic normal saline containing no preservatives. The patient dose is administered intravenously 15 to 30 minutes prior to the intravenous administration of 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate Tc 99m. TechneScan PYP should be injected by direct venipuncture. Heparinized catheter systems should be avoided.
Modified In Vivo/In Vitro Method Using Acid-Citrate-Dextrose (ACD): TechneScan PYP is reconstituted with sterile, non-pyrogenic normal saline containing no preservatives, and the patient dose is administered intravenously. An intravenous line containing a 3-way stopcock is inserted in a large peripheral vein and kept patent with a continuous drip of sterile, non-pyrogenic normal saline containing no preservatives. Thirty minutes after TechneScan PYP injection, the infusion line and stopcock are cleared by withdrawing and discarding approximately 5 milliliters of whole blood. Immediately following, approximately 5 milliliters of whole blood are withdrawn into a syringe containing 1 milliliter preservative-free acid-citrate-dextrose (ACD) and 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate Tc 99m. The stopcock is then turned, residual blood is flushed from the intravenous line, and the normal saline flow is readjusted. The syringe is gently rotated to mix and allowed to incubate at room temperature for 10 minutes prior to injection via the 3-way stopcock.
Modified In Vivo/In Vitro Method Using Heparin: TechneScan PYP is reconstituted with sterile, non-pyrogenic normal saline containing no preservatives, and the patient dose is administered intravenously. An infusion set fitted with a 3-way stopcock is placed in a large peripheral vein, and the intravenous line is heparinized with a saline solution containing 5-10 units preservative-free heparin per milliliter. Thirty minutes after TechneScan PYP injection, 3 milliliters of blood are withdrawn into a syringe containing 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate Tc 99m. Anticoagulation of the blood is provided by residual heparin in the intravenous line. The syringe is gently rotated to mix and allowed to incubate at room temperature for 10 minutes prior to injection via the 3-way stopcock.
Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if contents are turbid.
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Mallinckrodt Inc.
Kit For The Preparation Of Tc 99m Pyrophosphate | Mallinckrodt Inc.
Bone and Cardiac ImagingThe recommended adult doses of Technetium Tc 99m Pyrophosphate Injection are:
Indication Doses as
Technetium Tc 99 Fraction of
Vial Contents Required Skeletal Imaging 185 to 555 megabecquerels
(5 to 15 mCi) 0.07 to 0.91 Cardiac Imaging 370 to 555 megabecquerels
(10 to 15 mCi) 0.26 to 0.45Technetium Tc 99m Pyrophosphate Injection is injected intravenously over a 10- to 20-second period. For optimal results, bone imaging should be done one to six hours following administration. Cardiac imaging should be done 60 to 90 minutes following administration. The acute myocardial infarct can be visualized from 24 hours to nine 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.
The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration. It is also recommended that the radiochemical purity be checked prior to administration.
Blood Pool ImagingThe recommended adult dose of TechneScan PYP is one-third (0.33) to the entire vial contents, followed by 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate Tc 99m. Cardiac imaging should be done 10 minutes following the administration of sodium pertechnetate Tc 99m (in vivo method) or Tc 99m labeled red blood cells (modified in vivo/in vitro method) utilizing a scintillation camera interfaced to an electrocardiographic gating device.
In Vivo Method: TechneScan PYP is reconstituted with sterile, non-pyrogenic normal saline containing no preservatives. The patient dose is administered intravenously 15 to 30 minutes prior to the intravenous administration of 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate Tc 99m. TechneScan PYP should be injected by direct venipuncture. Heparinized catheter systems should be avoided.
Modified In Vivo/In Vitro Method Using Acid-Citrate-Dextrose (ACD): TechneScan PYP is reconstituted with sterile, non-pyrogenic normal saline containing no preservatives, and the patient dose is administered intravenously. An intravenous line containing a 3-way stopcock is inserted in a large peripheral vein and kept patent with a continuous drip of sterile, non-pyrogenic normal saline containing no preservatives. Thirty minutes after TechneScan PYP injection, the infusion line and stopcock are cleared by withdrawing and discarding approximately 5 milliliters of whole blood. Immediately following, approximately 5 milliliters of whole blood are withdrawn into a syringe containing 1 milliliter preservative-free acid-citrate-dextrose (ACD) and 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate Tc 99m. The stopcock is then turned, residual blood is flushed from the intravenous line, and the normal saline flow is readjusted. The syringe is gently rotated to mix and allowed to incubate at room temperature for 10 minutes prior to injection via the 3-way stopcock.
Modified In Vivo/In Vitro Method Using Heparin: TechneScan PYP is reconstituted with sterile, non-pyrogenic normal saline containing no preservatives, and the patient dose is administered intravenously. An infusion set fitted with a 3-way stopcock is placed in a large peripheral vein, and the intravenous line is heparinized with a saline solution containing 5-10 units preservative-free heparin per milliliter. Thirty minutes after TechneScan PYP injection, 3 milliliters of blood are withdrawn into a syringe containing 555 to 740 megabecquerels (15 to 20 millicuries) of sodium pertechnetate Tc 99m. Anticoagulation of the blood is provided by residual heparin in the intravenous line. The syringe is gently rotated to mix and allowed to incubate at room temperature for 10 minutes prior to injection via the 3-way stopcock.
Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. Do not use if contents are turbid.
![Kit For The Preparation Of Tc 99m Pyrophosphate (Technescan Pyp) Injection, Powder, Lyophilized, For Solution [Mallinckrodt Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=fdd81272-31be-4c37-8006-60b4fa24074e&name=technescan-pyp-injection-kit---alpha-ndcs-1.jpg)
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