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Technetium Tc99m Pyrophosphate
Overview
What is Kit for the Preparation of Technetium Tc99m Pyrophosphate?
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.
What does Kit for the Preparation of Technetium Tc99m Pyrophosphate look like?
What are the available doses of Kit for the Preparation of Technetium Tc99m Pyrophosphate?
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What should I talk to my health care provider before I take Kit for the Preparation of Technetium Tc99m Pyrophosphate?
Sorry No records found
How should I use Kit for the Preparation of Technetium Tc99m Pyrophosphate?
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.
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 -
Cardiac Imaging -
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 -
[555740 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.
What interacts with Kit for the Preparation of Technetium Tc99m Pyrophosphate?
None known.
What are the warnings of Kit for the Preparation of Technetium Tc99m Pyrophosphate?
Array
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.
What are the precautions of Kit for the Preparation of Technetium Tc99m Pyrophosphate?
General
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.
Bone Imaging
Both prior to and following Technetium Tc 99m Pyrophosphate Injection administration, if not contraindicated for the patient’s cardiac condition, patients should be encouraged to drink fluids. Patients should void as often as possible after the Technetium Tc 99m Pyrophosphate Injection to minimize background interference and unnecessary radiation exposure from accumulation in the bladder.
Cardiac Imaging
Array
Blood Pool Imaging
Array
Carcinogenesis, Mutagenesis, Impairment of Fertility
No long-term animal studies have been performed to evaluate carcinogenic potential or whether Technetium Tc 99m Pyrophosphate Injection affects fertility in males or females. Mutagenesis studies have not been conducted.
Pregnancy Category C
Animal reproduction and teratogenicity studies have not been conducted with Technetium Tc 99m Pyrophosphate Injection. It is also not known whether Technetium Tc 99 Pyrophosphate Injection can cause fetal harm when administered to a pregnant woman or can affect reproductive 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, to 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 Pyrophosphate Injection is excreted in human milk during lactation, therefore, formula feeding should be substituted for breast feeding.
Pediatric use
Safety and effectiveness in pediatric patients have not been established.
Geriatric use
Clinical studies of the Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
What are the side effects of Kit for the Preparation of Technetium Tc99m Pyrophosphate?
Some hypersensitivity reactions have been associated with pyrophosphate use.
What should I look out for while using Kit for the Preparation of Technetium Tc99m Pyrophosphate?
None known.
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.
What might happen if I take too much Kit for the Preparation of Technetium Tc99m Pyrophosphate?
Sorry No Records found
How should I store and handle Kit for the Preparation of Technetium Tc99m Pyrophosphate?
Storage and handlingKeep out of reach of children.Dispense in original container. Store tablets dispensed outside the original container in a tight light-resistant container with an expiration date not to exceed 3 months.Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature]Storage and handlingKeep out of reach of children.Dispense in original container. Store tablets dispensed outside the original container in a tight light-resistant container with an expiration date not to exceed 3 months.Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature]Storage and handlingKeep out of reach of children.Dispense in original container. Store tablets dispensed outside the original container in a tight light-resistant container with an expiration date not to exceed 3 months.Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature]Storage and handlingKeep out of reach of children.Dispense in original container. Store tablets dispensed outside the original container in a tight light-resistant container with an expiration date not to exceed 3 months.Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). [See USP Controlled Room Temperature]The Kit for the Preparation of Technetium Tc 99m Pyrophosphate InjectionIncluded 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]. The Kit for the Preparation of Technetium Tc 99m Pyrophosphate InjectionIncluded 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]. The Kit for the Preparation of Technetium Tc 99m Pyrophosphate InjectionIncluded 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]. The Kit for the Preparation of Technetium Tc 99m Pyrophosphate InjectionIncluded 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].
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
When injected intravenously, Technetium Tc 99m Pyrophosphate Injection has a specific affinity for areas of 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 Injection, an estimated 40 to 50 percent of the injected dose has been taken up by the skeleton, and approximately 0.01 to 0.02 percent per gram of acutely infarcted myocardium. Within a period of one hour, 10 to 11 percent remains in the vascular system, declining to approximately 2 to 3 percent twenty-four hours post injection.
The non-radioactive reconstituted Kit for the Preparation of Technetium Tc 99m Pyrophosphate Injection also has an affinity for red blood cells. When administered 30 minutes prior to the intravenous administration of Sodium Pertechnetate Tc 99m Injection, approximately 76 percent of the injected activity remains in the blood pool providing excellent images of the cardiac chambers.
Non-Clinical Toxicology
None known.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.
When given concurrently the following drugs may interact with thiazide diuretics.
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.
Some hypersensitivity reactions have been associated with pyrophosphate use.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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