Krajina: Izrael
Jazyk: angličtina
Zdroj: Ministry of Health
GALLIUM (67GA) CITRATE; SODIUM CITRATE
ISORAD LTD, ISRAEL
V09HX01
SOLUTION FOR INJECTION
GALLIUM (67GA) CITRATE 1.5 - 2 MCI; SODIUM CITRATE 1.5 - 2 MG
I.V
Required
ISORAD LTD., ISRAEL
GALLIUM (67GA) CITRATE
GALLIUM (67GA) CITRATE
Inflammatory lesions and abscesses. Primary and metastatic tumors Hodgkin's disease. Lymphomas and brochogenic carcinoma.
2015-12-31
1 SOREQ RADIOPHARMACEUTICALS NUCLEAR RESEARCH CENTER (NRC) YAVNE 81800, ISRAEL To Be Used In Diagnostic Institutes Only DESCRIPTION: Gallium Citrate Ga67 Injection is supplied in isotonic solution as a sterile, non-pyrogenic diagnostic radiopharmaceutical for intravenous administration. Each milliliter of the isotonic solution contains Gallium Citrate Ga67 1.5-2 mCi, at the time of calibration, Sodium Citrate 1.5-2 mg and Sodium Chloride 0.9% sol. The pH is adjusted to between 5-8 with hydrochloric acid and/or sodium hydroxide solution. Gallium Ga67, with a half-life of 78.3 hours, is cyclotron produced by the proton irradiation of enriched zinc oxide, is essentially carrier-free and contains negligible concentrations of other radioactive isotopes. The radionuclidic composition at calibration time is not less than 99.89% Gallium Ga67, less than 0.01% Gallium Ga66 and less than 0.1% due to other radio contaminants, each expressed as a percentage of total activity. The radionuclidic composition at calibration time is not less than 99.89% Gallium Ga67, essentially zero (0.0002%) Gallium Ga66 and essentially zero of other radio contaminants each expressed as a percentage of total activity. The chemical structure for Gallium Citrate is shown below: CH 2 COO HO C COO Ga CH 2 COO PHYSICAL CHARACTERISTICS Gallium Ga67 decays to stable Zinc Zn67 by electron capture with a physical half-life of 78.3 hours. 1 TABLE 1. PRINCIPAL RADIATION EMISSION DATA RADIATION MEAN %/DISINTEGRATION MEAN ENERGY (KEV) Gamma-3 35.7 93.3 Gamma-4 19.7 184.6 Gamma-6 16.0 300.2 ___ 1 Kocher, David C., “Radioactive Decay Data Tables”, DOE/TIC-11026 (1981). EXTERNAL RADIATION The specific gamma ray constant for Gallium Ga67 is 5.58 microcoulombs/Kg-hr-MBq (0.80R/hr-mCi) at 1cm. The first half value thickness of lead is 0.066cm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from the interposition of various thicknesses of Pb is shown in Table 2. For example, the use 0.41cm of Pb will de Prečítajte si celý dokument