Label: P32 SODIUM PHOSPHATE - p32 sodium phosphate solution

  • NDC Code(s): 51808-128-01
  • Packager: AnazaoHealth Corporation
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated June 19, 2012

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  • SPL UNCLASSIFIED SECTION

    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.

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  • 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.

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  • INDICATIONS AND USAGE

    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

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  • 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

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  • 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

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Figure 1

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  • INGREDIENTS AND APPEARANCE
    P32 SODIUM PHOSPHATE 
    p32 sodium phosphate solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51808-128
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PHOSPHORUS P-32 (UNII: 690284A407) (PHOSPHORUS P-32 - UNII:690284A407) PHOSPHORUS P-32 10 mCi  in 4 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    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 Business Operations
    AnazaoHealth Corporation 011038762 MANUFACTURE(51808-128)
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