The following Structured Product Label (SPL) was submitted to the FDA by Anazaohealth Corporation for the product P32 Sodium Phosphate (NDC 51808-127). 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, warnings, 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’s compounded P32 Chromic Phosphate is supplied as a sterile, nonpyrogenic aqueous solution. It contains 30 % dextrose solution, 1 mg sodium acetate, 2 % benzyl alcohol added as a preservative. Sodium hydroxide or hydrochloric acid may be added for pH adjustment.
P32 chromic phosphate is indicated for intracavitary instillation for the treatment of peritoneal or pleural effusions caused by metastatic disease, and may be injected interstitially for the treatment of cancer. It is also used in hemophilia patients for intraarticular injections.
Radioactive phosphorous works by local irradiation by beta emission.
P32 sodium phosphate should not be used in the presence of ulcerative tumors.
Not for intravascular injection.
Shake the vial well before injection.
For intraperitoneal instillation, administer 10-20 mCi
For intrapleural instillation, administer 6 to 12 mCi
Doses for interstitial use should be based on estimated gram weight of tumor, about 0.1 to 0.5 mCi/gm.
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5ed86373-figure-02 (5ed86373 Figure 02)
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