Description
AnazaoHealth’s compounded Cr-51 vial is a sterile, non-pyrogenic diagnostic radiopharmaceutical that consists up to 1 mCi of Cr-51 (precalibrated) in a volume up to 5 mL normal saline and 6 mg/mL benzyl alcohol.
Sodium Chromate 51
FDA Label NDC 51808-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Anazaohealth Corporation for the product Sodium Chromate 51 (NDC 51808-101). 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, mechanism of action, contraindications, dosage and administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications And Usage
Cr51 is indicated for use in determining red blood cell volume or mass, studying red blood cell survival time (in conditions such as hemolytic anemia), and evaluating blood loss
Mechanism Of Action
The chromium in this agent is present as the dianionic chromate ion in which form it appears to bind to the red blood cell in two steps, initially by a rapid but reversible attachment to the cell membrane followed by a slower nearly irreversible binding to intracellular hemoglobin and reduction to the anionic state. It has been suggested that the slow rate of uptake is dependent on the rate at which chromate can penetrate the cell membrane. Binding is maintained until the red blood cells are sequestered by the spleen or until elution of the chromium occurs into the plasma. The chromium is then readily excreted mainly in the urine. Once liberated by elution or erythrocyte senescence, chromium 51 is not available for relabeling of red cells.
In normal individuals the erythrocyte survival half-time T ½ as measured by the chromium 51 "random labeling" technique, generally ranges between 25 and 35 days. This apparent short survival time, when compared to the 120 day life span of the red blood cells, is due to the elution of chromium from the cells and to cell damage that probably occurs during the process of withdrawing them from the body and labeling. Subnormal T ½ may be indicative of blood toss, sequestration of red blood cells by the spleen, or shortened cell viability, as occurs In hemolytic anemia
Contraindications
There are no known contraindications for this preparation
Dosage And Administration
- The suggested dose range in the average patient (70kg) is:
Determination of red blood cell volume or mass-0.37 to 1.11 megabecquerels (10 to 30 microcuries). - Study of red blood cell survival time-5.55 megabecquerels (150 microcuries).
- Evaluation of blood loss-7.40 megabecquerels (200 microcuries)
Package Label.Principal Display Panel
Figure 2
40ecc37d-figure-02 (40ecc37d Figure 02)
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