Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
FLUDEOXYGLUCOSE F-18 (UNII: 0Z5B2CJX4D) (FLUDEOXYGLUCOSE F-18 - UNII:0Z5B2CJX4D)
NukeMed, Inc. dba SpectronRx
FLUDEOXYGLUCOSE F-18
FLUDEOXYGLUCOSE F-18 500 mCi in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
1 INDICATIONS AND USAGE Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: 1.1 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. 1.2 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. 1.3 Neurology For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. 4 CONTRAINDICATIONS None 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Fludeoxyglucose F 18 Injection. It is also not
16 HOW SUPPLIED Fludeoxyglucose F 18 Injection is supplied in a multi-dose, capped 10-50 mL glass vial containing between 0.15 – 18.5 GBq/mL (4 - 500 mCi/mL), of no carrier added 2-deoxy-2-[F-18] fluoro-D-glucose, at end of synthesis, in approximately 5 - 50 mL. The contents of each vial are sterile, pyrogen-free and preservative-free. Store the Fludeoxyglucose F 18 Injection 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 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 NUKEMED, INC. DBA SPECTRONRX ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE FLUDEOXYGLUCOSE F18 INJECTION. SEE FULL PRESCRIBING INFORMATION FOR FLUDEOXYGLUCOSE F18 INJECTION. INITIAL U.S. APPROVAL 1994 INDICATIONS AND USAGE (1) INDICATIONS AND USAGE (1) (1) (1) Fludeoxyglucose F18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: (1) • 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). (1) (1) DOSAGE AND ADMINISTRATION DOSAGE AND ADMINISTRATION Fludeoxyglucose F18 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 – 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 from its container and administer by intravenous injection (2). The recommended dose: • for adults is 5 – 10 mCi (185 – 370 MBq), in all indicated clinical settings(2.1). • for pediatric patients is 2 Przeczytaj cały dokument