Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3828
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Phosphocol P 32 (Injection, Suspension)
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| dailymed-instance:dosage |
The suggested dose range employed in the average patient (70 kg) is: Doses for interstitial use should be based on estimated gram weight of tumor, about 3.7 to 18.5 MBq/gm (0.1 to 0.5 mCi/gm). The patient dose should be measured by a suitable radioactivity calibration system immediately prior to administration.
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| dailymed-instance:descripti... |
Phosphocol P 32 is supplied as a sterile, nonpyrogenic aqueous suspension in a 30% dextrose solution with 2% benzyl alcohol added as preservative. Each milliliter contains 1 mg sodium acetate. Sodium hydroxide or hydrochloric acid may be present for pH adjustment.
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Chromic phosphate P 32 therapy should not be used in the presence of ulcerative tumors. Administration should not be made in exposed cavities or where there is evidence of loculation unless the extent of loculation is determined.
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| dailymed-instance:supply |
Catalog Number 470 Phosphocol P 32 - Chromic Phosphate P 32 Suspension (NDC No. 0019-N470-P0) is available in 10 milliliter vials containing 555 megabecquerels (15 millicuries) with a concentration of 185 megabecquerels (5 millicuries) per milliter. The radiopharmaceutical is manufactured with a specific activity of 122 megabecquerels (3.3 millicuries) per milligram Chromic Phosphate at the time of standardization. The U.S. Nuclear Regulatory Commission has approved distribution of this radiopharmaceutical to persons licensed to use byproduct material listed in Section 35.300, and to persons who hold an equivalent license issued by an Agreement State.
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General: As in the use of any other radioactive material care should be taken to insure minimum radiation exposure to the patient, consistent with proper patient management, and to insure minimum radiation exposure to occupational workers. Careful intracavitary instillation is required to avoid placing the dose of chromic phosphate P 32 into intrapleural or intraperitoneal loculations, bowel lumen or into the body wall. Intestinal fibrosis or necrosis and chronic fibrosis of the body wall have been reported to result from unrecognized misplacement of the therapeutic agent. The presence of large tumor masses indicates the need for other forms of treatment. However, when other forms of treatment fail to control the effusion, chromic phosphate P 32 may be useful. In bloody effusion, treatment may be less effective.<br/>Pediatric Use: Safety and effectiveness in pediatric patients has not been established. Risk of Malignancy Acute lymphocytic leukemia has been reported in children following the intra-articular administration of Phosphocol P 32 .
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| dailymed-instance:genericMe... |
Chromic Phosphate, P-32
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| dailymed-instance:fullName |
Phosphocol P 32 (Injection, Suspension)
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| dailymed-instance:adverseRe... |
Untoward effects may be associated with use of chromic phosphate P 32. These include transitory radiation sickness, bone marrow depression, pleuritis, peritonitis, nausea and abdominal cramping. Radiation damage may occur if accidentally injected interstitially or into a loculation.<br/>Post-marketing Experience: The following adverse reactions associated with the use of Phosphocol P32 have been identified during post approval use: Leukemia in Children Radiation injury (necrosis and fibrosis) to the small bowel, cecum, and bladder following administration of P 32 into the peritoneal cavity. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
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| dailymed-instance:warning |
Not for intravascular use. This radiopharmaceutical should not be administered to patients who are pregnant or during lactation unless the therapeutic benefits outweigh the potential hazards. Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides produced by nuclear reactor or particle accelerator and whose experience and training have been approved by the appropriate government agency authorized to license the use of radionuclides.<br/>Leukemia: Phosphocol P 32 may increase the risk for leukemia in certain situations. Two children (ages 9 and 14) with hemophilia developed acute lymphocytic leukemia approximately 10 months after intra-articular injections of Phosphocol P 32 (0.6 and 1.5 mCi total dose). Phosphocol P 32 is not indicated in the intra-articular treatment of hemarthroses.
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Phosphocol P 32
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