Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
Fludeoxyglucose F-18 (UNII: 0Z5B2CJX4D) (Fludeoxyglucose F-18 - UNII:0Z5B2CJX4D)
SOFIE Co.
Fludeoxyglucose F-18
Fludeoxyglucose F-18 300 mCi 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 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
Fludeoxyglucose F 18 Injection, USP is supplied in a multi-dose form, capped 30 mL or 50 mL glass vial containing between 0.740 to 11.1 GBq (20 to 300 mCi/mL), of no carrier added 2-deoxy-2-[18 F]fluoro-D-glucose, at end of synthesis, in approximately 10 to 50mL. The contents of each vial are sterile, pyrogen-free and preservative-free. NDC 49609-101-01 (30mL); 49609-101-02 (50mL) This radiopharmaceutical is licensed by the Nuclear Regulatory Commission or an Agreement State for distribution to persons licensed for radioactive material under equivalent licenses of an Agreement State or Licensing State. Store the Fludeoxyglucose F 18 Injection, USP vial upright in a lead shielded container at 20° to 25 °C (68° to 77 °F); excursions permitted to 15° to 30 °C (59 to 86 °F). Store and dispose of Fludeoxyglucose F 18 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 F 18 Injection, USP within 12 hours from the EOS time.
Abbreviated New Drug Application
FLUDEOXYGLUCOSE F 18- FLUDEOXYGLUCOSE F-18 INJECTION SOFIE CO. ---------- 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. FLUDEOXYGLUCOSEF 18 INJECTION, USP, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 2005 RECENT MAJOR CHANGES None. 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. 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 F 18 Injection emits radiation. Use procedures to minimize radiation exposure. Screen for blood glucose abnormalities. In the oncology and neurology setting, 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 settings, 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 in the Prečítajte si celý dokument