FDA Label for P32 Sodium Phosphate

View Indications, Usage & Precautions

P32 Sodium Phosphate Product Label

The following document was submitted to the FDA by the labeler of this product Anazaohealth Corporation. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Description



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.


Indications And Usage



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.


Mechanism Of Action



Radioactive phosphorous works by local irradiation by beta emission.


Contraindications



P32 sodium phosphate should not be used in the presence of ulcerative tumors.


Warnings



Not for intravascular injection.


Dosage And Administration



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.


Package Label.Principal Display Panel



Figure 1


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