Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
FLUDEOXYGLUCOSE F-18 (UNII: 0Z5B2CJX4D) (FLUDEOXYGLUCOSE F-18 - UNII:0Z5B2CJX4D)
The Methodist Hospital Research Institute
FLUDEOXYGLUCOSE F-18
FLUDEOXYGLUCOSE F-18 0.3 Ci in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Fludeoxyglucose F18 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 USP 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 radiatio
Fludeoxyglucose F18 Injection USP is supplied in a multi-dose, capped 30 mL glass vial containing between 0.740 – 11.1GBq/mL (20 - 300 mCi/mL), of no carrier added 2-deoxy-2-[F 18] fluoro-D- glucose, at end of synthesis, in approximately 25 - 30 mL. The contents of each vial are sterile, pyrogen- free and preservative-free. Store the Fludeoxyglucose F18 Injection USP vial upright in a lead shielded container at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Store and dispose of Fludeoxyglucose F18 Injection USP 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 F18 Injection USP within 12 hours from the EOS time.
Abbreviated New Drug Application
FLUDEOXYGLUCOSE F18- FLUDEOXYGLUCOSE F18 INJECTION, SOLUTION THE METHODIST HOSPITAL RESEARCH INSTITUTE ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FLUDEOXYGLUCOSE F18 INJECTION USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUDEOXYGLUCOSE F18 INJECTION USP. FLUDEOXYGLUCOSE F18 INJECTION USP FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2005 RECENT MAJOR CHANGES Warnings and Precautions: ( 5.1, 5.2) 7/2010 Adverse Reactions ( 6) 7/2010 Pregnancy ( 8.1) 8/2021 Lactation ( 8.2) 8/2021 INDICATIONS AND USAGE Fludeoxyglucose F18 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. 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. Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures ( 1). DOSAGE AND ADMINISTRATION Fludeoxyglucose F18 Injection USP 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 – 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 – 75 grams) prior to the drug’s injection facilitates localization of cardiac ischemia ( 2.3). Aseptically withdraw Fludeoxyglucose F18 Injection USP from its container and administer by i Прочитайте повний документ