P32 Sodium Phosphate: Package Insert and Label Information

P32 SODIUM PHOSPHATE — phosphorus p-32 injection, suspension
AnazaoHealth Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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.

DECAY CHART

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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1

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P32 SODIUM PHOSPHATE
p32 sodium phosphate injection, suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51808-127
Route of Administration INTRA-ARTICULAR, INTRAPERITONEAL, INTERSTITIAL, INTRAPLEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHOSPHORUS P-32 (PHOSPHORUS P-32) PHOSPHORUS P-32 5 mCi in 1 mL
Inactive Ingredients
Ingredient Name Strength
DEXTROSE 0.3 g in 1 mL
BENZYL ALCOHOL 0.02 mL in 1 mL
SODIUM ACETATE 1 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51808-127-01 3 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/19/2012
Labeler — AnazaoHealth Corporation (011038762)
Establishment
Name Address ID/FEI Operations
AnazaoHealth Corporation 011038762 MANUFACTURE (51808-127)

Revised: 06/2012 AnazaoHealth Corporation

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