P32 SODIUM PHOSPHATE - p32 sodium phosphate 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.

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P32 Chromic Phosphate Suspension

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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51808-127
Route of AdministrationINTRA-ARTICULAR, INTRAPERITONEAL, INTERSTITIAL, INTRAPLEURAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHOSPHORUS P-32 (UNII: 690284A407) (PHOSPHORUS P-32 - UNII:690284A407) PHOSPHORUS P-325 mCi  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DEXTROSE (UNII: IY9XDZ35W2) 0.3 g  in 1 mL
BENZYL ALCOHOL (UNII: LKG8494WBH) 0.02 mL  in 1 mL
SODIUM ACETATE (UNII: 4550K0SC9B) 1 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51808-127-013 mL in 1 VIAL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/19/2012
Labeler - AnazaoHealth Corporation (011038762)
Establishment
NameAddressID/FEIBusiness Operations
AnazaoHealth Corporation011038762MANUFACTURE(51808-127)

Revised: 6/2012
Document Id: 5ed86373-1e27-42fc-a3b3-b198944f0dff
Set id: 4996cd1e-4338-43d7-b7aa-418909ab8c16
Version: 1
Effective Time: 20120619
 
AnazaoHealth Corporation