Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
Fludeoxyglucose F-18 (UNII: 0Z5B2CJX4D) (Fludeoxyglucose F-18 - UNII:0Z5B2CJX4D)
University of North Dakota
Fludeoxyglucose F-18
Fludeoxyglucose F-18 500 mCi in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Fludeoxyglucose F 18 Injection,USP is indicated in PET (positron emission tomography) for: 1. Identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. 2. 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 diagnosis of cancer. 3. Assessment of 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 not indicated for distinguishing epileptogenic foci from brain tumors or other brain lesions which may cause seizures. None known
NDC 24468-001-10 Fludeoxyglucose F18 Injection, USP is supplied in a multi-dose, septum capped 10 mL glass vial containing between 148 - 1480 MBq/mL (4 — 500 mCi/mL) of no carrier added 2-deoxy-2-[ 18 F]fluoro-D-glucose at end of synthesis, in approximately 6 mL. This radiopharmaceutical is licensed by the North Dakota Department of Health for distribution to persons authorized to receive the licensed material pursuant to the terms and conditions of a specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement State. [ 18 F]FDG should be stored upright in a lead shielded container at controlled room temperature. Storage and disposal of [ 18 F]FDG should be in accordance with the regulations and a specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement State. Fludeoxyglucose F18 Injection, USP should be used within 12 hours from the end of synthesis, which is provided on the container label. Caution: Federal Law Prohibits Dispensing Without Prescription. Manufactured by: University of North Dakota Cyclotron and Positron Operations 501 N Columbia Rd., Grand Forks, ND 58203
Abbreviated New Drug Application
FLUDEOXYGLUCOSE F-18- FLUDEOXYGLUCOSE F-18 INJECTION INJECTION UNIVERSITY OF NORTH DAKOTA ---------- DESCRIPTION Fludeoxyglucose F18 Injection, USP is a positron emitting radiopharmaceutical containing no-carrier added radioactive 2-deoxy-2-[ F]fluoro-D-glucose that 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-glucose, abbreviated [ F]FDG, has a molecular formula of C H F0 with a molecular weight of 181.26 daltons, and has the following chemical structure: Fludeoxyglucose F18 Injection, USP is provided as a ready to use sterile, pyrogen free, clear, colorless solution. Each milliliter contain between 150 to 1850 MBq (4 — 500 mCi) of 2-deoxy-2-[ F]fluoro-D-glucose at the end of synthesis (EOS), and 9 mg of sodium chloride in citrate buffer. The pH of the solution is between 4.5 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 ( +) emission and has a half life of 110 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. PRINCIPLE EMISSION DATA FOR FLUORINE F-18 Radiation/Emission % Per Disintigration Mean Energy Positron (+) 96.73 249.8 keV Gamma (+/-)* 193.46 511.0 keV *Produced by positron annihilation From: Kocher, D.C. "Radioactive Decay Tables" DOE/TIC-11026, 89 (1981). EXTERNAL RADIATION 18 18 18 8 11 18 8 18 The specific gamma ray constant for Fluorine F 18 is 6.0 R/hr/mCi (0.3 Gy/hr/kBq) 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 thicknesses 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 coefficient of at Baca dokumen lengkapnya