Sodium Phosphate P 32

Dosage Form: intravenous solution

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.

P32 Sodium Phosphate

Dear Medical Professional,

Per your order, we have compounded P32 Sodium Phosphate as a sterile intravenous solution dispensed in a 10 mL plastic vial with a total volume of 4 mL. The characteristics of this preparation are described below.

Sodium Phosphate P 32 Description

AnazaoHealth’s compounded P32 sodium phosphate vial is a sterile, non-pyrogenic radiopharmaceutical. The intravenous solution contains 0.25 N sodium acetate buffer, which is made of 0.9% sodium chloride and 0.09% sodium phosphate dibasic, and is compounded to a total volume of 4 mL. The pH of the solution is between 5 and 6.

Indications and Usage for Sodium Phosphate P 32

P32 sodium phosphate is indicated for the treatment of polycythemia vera and is effective for the treatment of chronic myelocytic leukemia and chronic lymphocytic leukemia. It may also be used in the palliative treatment of selected patients with multiple areas of skeletal metastases

Mechanism of Action

Radioactive phosphorous concentrates to a very high degree in rapidly proliferating tissues

Contraindications

P32 sodium phosphate should not be used as part of a sequential treatment with a chemotherapeutic agent. It should not be administered when the leukocyte count is below 5,000/cu mm or a platelet count that is below 150,000/cu mm.

In chronic myelocytic leukemia, it should not be administered when the leukocyte count is below 20,000/cu mm.

For the treatment of bone metastases, it is usually not administered when the leukocyte count is below 5,000/ cu mm and platelet count is below 100,000/cu mm

Sodium Phosphate P 32 Dosage and Administration

For polycythemia vera, intravenous dosages from 1 to 8 mCi are usually given depending upon the stage of disease and the size of the patient. Repeat doses must be adjusted to individual needs. For chronic leukemia, the individual dose is 6 to 15 mCi, usually administered with concomitant hormone manipulation

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1

P32 SODIUM PHOSPHATE 
p32 sodium phosphate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51808-128
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHOSPHORUS P-32 (PHOSPHORUS P-32) PHOSPHORUS P-32 10 mCi  in 4 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM ACETATE  
Packaging
# Item Code Package Description
1 NDC:51808-128-01 4 mL in 1 VIAL
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(51808-128)
Revised: 06/2012
 
AnazaoHealth Corporation



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