Kit for the Preparation of Technetium Tc99m Pyrophosphate 12 mg/10mL
technetium tc99m pyrophosphate · INJECTION · Sun Pharmaceutical Industries, Inc.
Technetium Tc99M Pyrophosphate is a radioactive diagnostic injection used in nuclear medicine imaging to evaluate heart function and detect certain cardiac conditions. It is administered intravenously and helps physicians visualize blood flow and tissue damage in the heart.
Key Facts
- Brand Name
- Kit for the Preparation of Technetium Tc99m Pyrophosphate
- Generic Name
- technetium tc99m pyrophosphate
- NDC Code (Product)
45567-0060- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Strength
- 12 mg/10mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA019039
- Drug Class
- Radioactive Diagnostic Agent [EPC]
- Marketing Start
- 06/30/1987
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND 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
DOSAGE AND 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 ant…
Warnings
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 Technet…
Contraindications
CONTRAINDICATIONS None known.
Adverse Reactions
ADVERSE REACTIONS Some hypersensitivity reactions have been associated with pyrophosphate use.
Frequently Asked Questions
What is Kit for the Preparation of Technetium Tc99m Pyrophosphate used for?
Technetium Tc99M Pyrophosphate is a radioactive diagnostic injection used in nuclear medicine imaging to evaluate heart function and detect certain cardiac conditions. It is administered intravenously and helps physicians visualize blood flow and tissue damage in the heart.
Is Kit for the Preparation of Technetium Tc99m Pyrophosphate a controlled substance?
Kit for the Preparation of Technetium Tc99m Pyrophosphate is not classified as a controlled substance by the DEA.
What is the generic name for Kit for the Preparation of Technetium Tc99m Pyrophosphate?
The generic name for Kit for the Preparation of Technetium Tc99m Pyrophosphate is technetium tc99m pyrophosphate. There are no other listed brand versions of technetium tc99m pyrophosphate.
What is the NDC code for Kit for the Preparation of Technetium Tc99m Pyrophosphate 12 mg/10mL?
The NDC (National Drug Code) for Kit for the Preparation of Technetium Tc99m Pyrophosphate 12 mg/10mL is 45567-0060, listed by Sun Pharmaceutical Industries, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)