国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
FLUDEOXYGLUCOSE F-18 (UNII: 0Z5B2CJX4D) (FLUDEOXYGLUCOSE F-18 - UNII:0Z5B2CJX4D)
Hamamatsu/Queen’s PET Imaging Center, LLC
FLUDEOXYGLUCOSE F-18
FLUDEOXYGLUCOSE F-18 100 mCi in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Fludeoxyglucose F 18 Injection, USP is indicated in positron emission tomography (PET) imaging for assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnoses of cancer. Fludeoxyglucose F 18 Injection, USP is indicated in positron emission tomography (PET) imaging in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging, for the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function. Fludeoxyglucose F 18 Injection, USP is indicated in positron emission tomography (PET) imaging in patients for the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. None known
Fludeoxyglucose F 18 Injection, USP is supplied in a multi-dose septum capped 30 mL glass vial containing between 0.37 – 3.7 GBq/mL (10 - 100 mCi/mL), of no carrier added 2-deoxy-2 [18 F]fluoro-D-glucose, at end of synthesis, in approximately 24 mL. NDC# 76376 - 618- 30 This radiopharmaceutical is licensed by the Nuclear Regulatory Commission, for distribution to entities licensed pursuant to 10 CFR 35.200.
Abbreviated New Drug Application
FLUDEOXYGLUCOSE F 18- FLUDEOXYGLUCOSE F-18 INJECTION, SOLUTION HAMAMATSU/QUEEN’S PET IMAGING CENTER, LLC ---------- FLUDEOXYGLUCOSE F 18 INJECTION, USP, FOR INTRAVENOUS USE DESCRIPTION Fludeoxyglucose F 18 Injection, USP is a positron emitting radiopharmaceutical containing no-carrier added radioactive 2-deoxy-2-[ F]fluoro-D-g1ucose, which is used for diagnostic purposes in conjunction with Positron Emission Tomography (PET). It is administered by intravenous injection. The active ingredient 2-deoxy-2-[ F]fluoro-D-g1ucose (Fludeoxyglucose F 18), abbreviated [ F] FDG, has a molecular formula of C H FO with a molecular weight of 181.26 Daltons, and has the following chemical structure: Fludeoxyglucose F 18 Injection, USP is provided as a ready to use isotonic, sterile, pyrogen free, clear, colorless citrate buffered solution. Each mL contains between 0.37 to 3.7 GBq (10.0 – 100 mCi) of 2-deoxy-2-[ F]fluoro-D glucose at the end of synthesis (EOS), 4.5 mg of sodium chloride and 7.2 mg of citrate ions. The pH of the solution is between 5.0 to 7.5. The solution is packaged in a multiple-dose glass vial and does not contain any preservative. PHYSICAL CHARACTERISTICS Fluorine F 18 decays by positron (β ) emission and has a half-life of 109.7 minutes. The principal photons useful for diagnostic imaging are the 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron (Table 1). TABLE 1. PRINCIPAL RADIATION EMISSION DATA FOR FLUORINE F 18 * RADIATION/EMIS S ION % PER DISINTEGRATION MEAN ENERGY Positron(β ) 96.73 249.8 keV Gamma(±) 193.46 511.0 keV EXTERNAL RADIATION The specific gamma ray constant for fluorine F 18 is 6.0 R/hr/mCi (0.3 Gy/hr/kB) at 1cm. The half- value layer (HVL) for the 511 keV photons is 4.1 mm lead (Pb). A range of values for the attenuation of radiation results from the interposition of various thickness of Pb. The range of attenuation coefficients for this radionuclide is shown in Table 2. For example, the interposition of an 8.3 mm thickness of Pb, with a 完全なドキュメントを読む