P32 SODIUM PHOSPHATE SOLUTION [ANAZAOHEALTH CORPORATION]

P32 SODIUM PHOSPHATE SOLUTION [ANAZAOHEALTH CORPORATION]
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NDC 51808-128-01
Set ID 735f92e3-cc92-4d9b-afe8-f935a685ee78
Category HUMAN PRESCRIPTION DRUG LABEL
Packager AnazaoHealth Corporation
Generic Name
Product Class
Product Number
Application Number
  • 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.

  • 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

    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

  • 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

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  • INGREDIENTS AND APPEARANCE
    P32 SODIUM PHOSPHATE 
    p32 sodium phosphate solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51808-128
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHOSPHORUS P-32 (UNII: 690284A407) (PHOSPHORUS P-32 - UNII:690284A407) PHOSPHORUS P-3210 mCi  in 4 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51808-128-014 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(51808-128)

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