Label: P32 SODIUM PHOSPHATE solution
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Contains inactivated NDC Code(s)
NDC Code(s): 51808-128-01 - Packager: AnazaoHealth Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated June 19, 2012
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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.
- INDICATIONS AND USAGE
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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
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
P32 SODIUM PHOSPHATE
p32 sodium phosphate solutionProduct 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)
