FLUDEOXYGLUCOSE F18 injection

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

FLUDEOXYGLUCOSE F-18 (UNII: 0Z5B2CJX4D) (FLUDEOXYGLUCOSE F-18 - UNII:0Z5B2CJX4D)

Saatavilla:

The University of Texas MD Anderson Cancer Center

INN (Kansainvälinen yleisnimi):

FLUDEOXYGLUCOSE F-18

Koostumus:

FLUDEOXYGLUCOSE F-18 300 mCi in 1 mL

Antoreitti:

INTRAVENOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Fludeoxyglucose F18 Injection 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 dose.

Tuoteyhteenveto:

Fludeoxyglucose F 18 Injection is supplied in a multi-dose, 30 mL glass vial containing: or The total volume and total radioactivity per vial are variable. The contents of each vial are sterile, pyrogen-free and preservative free. Each vial is enclosed in a shielding container of appropriate thickness. Store the Fludeoxyglucose F 18 Injection vial upright in a shielded container at 10 - 25°C (50 - 77°F), excursions permitted to 15 - 30°C (59 - 86°F) [ See USP Controlled Room Temperature ]. Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

FLUDEOXYGLUCOSE F18- FLUDEOXYGLUCOSE F18 INJECTION
THE UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
FLUDEOXYGLUCOSE F18 INJECTION SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR FLUDEOXYGLUCOSE F18
INJECTION. FLUDEOXYGLUCOSE F18
INJECTION
INITIAL U.S. APPROVAL: 2005
INDICATIONS AND USAGE
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)
DOSAGE AND ADMINISTRATION
Fludeoxyglucose F18 Injection emits radiation. Use procedures to
minimize radiation exposure. Screen for blood glucose
abnormalities. (2)
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).
(2)
Aseptically withdraw Fludeoxyglucose F18 Injection from its container
and administer by intravenous injection (2). The
recommended dose: (2)
for adults is 5 – 10 mCi (185 – 370 MBq), in all indicated
clinical settings (2.1).