The following Structured Product Label (SPL) was submitted to the FDA by Anazaohealth Corporation for the product Pyrophosphate (NDC 51808-218). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, indications and usage, dosage and administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
AnazaoHealth compounds Stannous-Pyrophosphate as a sterile lyophilized powder for the preparation of Tc99m Pyrophosphate. Each 10 ml reaction vial contains: 27.6 milligrams sodium pyrophosphate decahydrate, 3.5 milligrams stannous chloride, all lyophilized 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
Stannous Pyrophosphate is indicated as a blood pool imaging agent which may be used for gated pool imaging and for the detection of sites of gastrointestinal bleeding. When administered intravenously, 15-30 minutes prior to intravenous administration of sodium pertechnetate Tc99m 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.
It is also indicated as 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.
The recommended adult dose of Tc99m Pyrophosphate Injection is:
Figure 1
E247d821-figure-01 (E247d821 Figure 01)
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