国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
FLUDEOXYGLUCOSE F-18 (UNII: 0Z5B2CJX4D) (FLUDEOXYGLUCOSE F-18 - UNII:0Z5B2CJX4D)
Precision Nuclear, LLC
FLUDEOXYGLUCOSE F-18
FLUDEOXYGLUCOSE F-18 500 mCi in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Fludeoxyglucose F 18 Injection USP is indicated for positron emission tomography (PET) imaging in the following settings: 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 diagnosis of cancer. For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. None Risk Summary Data from published case series and case reports describe Fludeoxyglucose F 18 Injection crossing the placenta with uptake by the fetus (see Data). All radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation d
Fludeoxyglucose F 18 Injection is supplied in a multi-dose, capped 30-mL or 50-mL glass vial containing between 0.74 to 18.5 GBq/mL (20 to 500 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D-glucose, at end of synthesis, in approximately 23 to 30 mL. The contents of each vial are sterile, pyrogen-free and preservative-free. 30-mL vials: NDC 52768-001-30 50-mL vials: NDC 52768-001-50 This radiopharmaceutical is licensed by the State of Tennessee, Department of Environment and Conservation for distribution to entities licensed pursuant to Chapter 1200-02-07 Division of Radiological Health Regulations or under equivalent licenses of an Agreement State or a Licensing State. Store the Fludeoxyglucose F 18 Injection vial upright in a lead shielded container at 20 to 25℃ (68 to 77°F); excursions permitted to 15 to 30℃ (59 to 86°F) [see USP Controlled Room Temperature ]. Store and dispose of Fludeoxyglucose F 18 Injection in accordance with the regulations and a general license, or its equivalent, of an Agreement State or a Licensing State. The expiration date and time are provided on the container label. Use Fludeoxyglucose F 18 Injection within 12 hours from the EOS time.
Abbreviated New Drug Application
FLUDEOXYGLUCOSE F-18- FLUDEOXYGLUCOSE F-18 INJECTION, SOLUTION PRECISION NUCLEAR, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FLUDEOXYGLUCOSE F 18 INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUDEOXYGLUCOSE F 18 INJECTION. FLUDEOXYGLUCOSE F 18 INJECTION USP, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2005 INDICATIONS AND USAGE Fludeoxyglucose F 18 Injection USP is indicated for positron emission tomography (PET) imaging in the following settings: Oncology: 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 diagnosis of cancer. (1.1) Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging. (1.2) Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. (1.3) DOSAGE AND ADMINISTRATION Fludeoxyglucose F 18 Injection emits radiation. Use procedures to minimize radiation exposure. Screen for blood glucose abnormalities. In the oncology and neurology settings, instruct patients to fast for 4 to 6 hours prior to the drug's injection. Consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to the drug's administration (5.2). In the cardiology setting, administration of glucose-containing food or liquids (e.g., 50 to 75 grams) prior to the drug's injection facilitates localization of cardiac ischemia (2.3). Aseptically withdraw Fludeoxyglucose F 18 Injection from its container and administer by intravenous injection (2). The recommended dose: for adults is 5 to 10 mCi (185 to 370 MBq), in all indicated clinical settings (2.1). for pediatric patients is 2.6 mCi 阅读完整的文件