Technescan PYP

Rx only

Diagnostic–For Intravenous Use

When injected intravenously, Technetium Tc 99m Pyrophosphate has a specific affinity for areas of altered osteogenesis. It is also concentrated in the injured myocardium, primarily in areas of irreversibly damaged myocardial cells.

One to two hours after intravenous injection of Technetium Tc 99m Pyrophosphate, an estimated 40 to 50% of the injected dose had been taken up by the skeleton, and approximately 0.01 to 0.02% per gram of acutely infarcted myocardium. Within a period of one hour, 10 to 11% remains in the vascular system, declining to approximately 2 to 3% twenty-four hours post injection. The average urinary excretion was observed to be about 40% of the administered dose after 24 hours.

TechneScan PYP also has an affinity for red blood cells. When administered 15 to 30 minutes prior to the intravenous administration of sodium pertechnetate Tc 99m (in vivo red blood cell labeling), approximately 75% of the injected radioactivity remains in the blood pool providing excellent images of the cardiac chambers. When the modified in vivo/in vitro red blood cell labeling method is used, comparable percentages of the injected radioactivity are obtained.

Toxicology data are available upon request.

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.

General

TechneScan PYP should not be used more than six hours after preparation.

The components of the kit are sterile and non-pyrogenic. 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.

The imaging of gastrointestinal bleeding is dependent on such factors as the region of imaging, rate and volume of the bleed, efficacy of labeling of the red blood cells and timeliness of imaging. Due to these factors, images should be taken sequentially over a period of time until a positive image is obtained or clinical conditions warrant the discontinuance of the procedure. The period of time for collecting the images may range up to thirty-six hours.

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.

The contents of the TechneScan PYP reaction vial may be used for the preparation of Technetium Tc 99m Pyrophosphate Injection. TechneScan PYP may also be reconstituted with sterile, non-pyrogenic normal saline containing no preservatives and injected intravenously prior to labeling of red blood cells with sodium pertechnetate Tc 99m using either the in vivo or modified in vivo/in vitro method.

As in the use of any other radioactive material, care should be taken to ensure minimum radiation exposure to the patient, consistent with proper patient management, and to ensure 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 produced by nuclear reactor or particle accelerator and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.

Overdosage

In case of overdose of Technetium Tc 99m Pyrophosphate, encourage patients to maintain hydration and to void frequently to minimize radiation exposure.

Bone Imaging

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.

Cardiac Imaging

The patient's cardiac condition should be stable before beginning the cardiac imaging procedure.

If not contraindicated by the cardiac status, patients should be encouraged to ingest fluids and to void frequently in order to reduce unnecessary radiation exposure.

Interference from chest wall lesions such as breast tumors and healing rib fractures can be minimized by employing the three recommended projections.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long term animal studies have been performed to evaluate carcinogenic or mutagenic potential, or whether this drug affects fertility in males or females.

Pregnancy Category C

Animal reproduction studies have not been conducted with Technetium Tc 99m Pyrophosphate Injection. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Technetium Tc 99m Pyrophosphate Injection should be given to a pregnant woman only if clearly needed.

Ideally, examinations using radiopharmaceuticals, especially those elective in nature, of a woman of childbearing capability should be performed during the first few (approximately 10) days following the onset of menses.

Nursing Mothers

Technetium Tc 99m is excreted in human milk during lactation, therefore, formula feedings should be substituted for breast feeding.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Catalog Number 094.

TechneScan PYP is supplied as a lyophilized powder packaged in vials. Each vial contains 11.9 mg sodium pyrophosphate, 3.2 mg (minimum) stannous chloride (SnCl2•2H2O) and 4.4 milligrams (maximum) total tin expressed as stannous chloride (SnCl2•2H2O), sealed 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.

Kit containing 5 vials is available.

The TechneScan PYP Kit must be maintained in a refrigerator, 2° to 8°C (36° to 46°F) until use. The reconstituted vial should be stored at controlled room temperature, 20° to 25°C (68° to 77°F).

Procedural Precautions

All transfer and vial stopper entries must be done using aseptic techniques.

Procedure

Note 1: Wear waterproof gloves during the entire preparation procedure and during subsequent patient dose withdrawals from the reaction vial.

Note 2: Make all transfers of sodium pertechnetate Tc 99m solution during the preparation procedure with an adequately shielded syringe.

Note 3: Keep the Radioactive Preparation in the lead shield described below (with cap in place) during the useful life of the Radioactive Preparation. Make all withdrawals and injections of the Radioactive Preparation with an adequately shielded syringe.

1. A Technescan PYP reaction vial is removed from the refrigerator and approximately five (5) minutes are allowed for the contents to come to room temperature.
2. Attach radioassay information label with radiation warning symbol to the reaction vial and place the vial in a lead Dispensing Shield fitted with a lead cap and having a minimum wall thickness of 1/8 inch. Do not remove reaction vial from the Dispensing Shield except, temporarily, for Step 5 below.
3. Sodium pertechnetate Tc 99m solution (1 to 10 milliliters) is added to the reaction vial. In choosing the amount of technetium Tc 99m radioactivity to be used in the preparation of the Technetium Tc 99m Pyrophosphate Injection, the labeling efficiency, number of patients, administered radioactive dose, and radioactive decay must be taken into account. The recommended maximum amount of technetium Tc 99m to be added to the reaction vial is 3.7 gigabecquerels (100 millicuries).
4. With the reaction vial in the Dispensing Shield (with cap in place), shake sufficiently to bring the lyophilized material into solution. Allow to stand for five (5) minutes at room temperature.
5. Using proper shielding, the reaction vial should be visually inspected. The resulting solution should be clear and free of particulate matter. If not, the reaction vial should not be used.
6. Assay the product in a suitable calibrator and record the time, date of preparation and the activity of the Technetium Tc 99m Pyrophosphate Injection onto the radioassay information label. Store the reaction vial in the Dispensing Shield at
   15° to 30°C when not in use and discard after six (6) hours from the time of preparation.

1. A Technescan PYP reaction vial is removed from the refrigerator and approximately five (5) minutes are allowed for the contents to come to room temperature.
2. Reconstitute the reaction vial with 3 milliliters of sterile, non-pyrogenic normal saline containing no preservatives.
3. Shake the reaction vial sufficiently to bring the lyophilized material into solution. Allow to stand for five (5) minutes at room temperature.
4. The reaction vial should be visually inspected. The resulting solution should be clear and free of particulate matter. If not, the reaction vial should not be used.
5. Store reconstituted reaction vial at 15° to 30°C when not in use and discard after six (6) hours from time of preparation.

This reagent kit is approved for distribution to persons licensed by the U.S. Nuclear Regulatory Commission to use byproduct material identified in Section 35.200 or under an equivalent license of an Agreement State.

Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and other brands are trademarks of a Mallinckrodt company.

© 2017 Mallinckrodt.

Manufactured by: Mallinckrodt Nuclear Medicine LLC
Maryland Heights, MO 63043

Made in USA

A094I0

Rev 03/2017                 

Mallinckrodt™
Pharmaceuticals                                                                       

Technescan™ PYP™

(Stannous Pyrophosphate)
Vial contains 11.9 mg Sodium Pyrophosphate, 3.2 mg (minimum) stannous chloride (SnCl2•2H2O) and 4.4 mg (maximum) total tin as stannous chloride (SnCl2•2H2O). Prior to lyophilization the pH is adjusted with hydrochloric acid. The pH of the reconstituted drug is between 4.5 and 7.5. The contents are sealed under nitrogen.
Sterile, non-pyrogentic. For Intravenous use after drug preparation. See package insert for directions for use.
Do not use Tc 99m solutions containing an oxidizing agent.
Rx only
Store refrigerated at 2° to 8°C (36° to 46°F).

Manufactured by:
Mallinckrodt Nuclear Medicine LLC
Maryland Heights, MO 63043

Made in USA

Mallinckrodt™

Pharmaceuticals

A094V0
R10/2015