FLUDEOXYGLUCOSE F 18 injection

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

NCM-USA Bronx LLC

INN (इंटरनेशनल नाम):

FLUDEOXYGLUCOSE F-18

रचना:

FLUDEOXYGLUCOSE F-18 300 mCi in 1 mL

प्रशासन का मार्ग:

INTRAVENOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 do

उत्पाद समीक्षा:

Fludeoxyglucose F 18 Injection 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 16 mL. The contents of each vial are sterile, pyrogen-free and preservative-free. NDC 24445-334-30 This radiopharmaceutical is licensed by the State of New York, Department Of Health, Bureau of Environmental Radiation Protection, for distribution to persons licensed pursuant to New York's Regulatory Code for Radioactive material specified in Chapter 1-Part 16 of the State Sanitary Code, as appropriate, or under equivalent licenses of an Agreement State or Licensing State. 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) [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.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

FLUDEOXYGLUCOSE F 18- FLUDEOXYGLUCOSE F 18 INJECTION
NCM-USA BRONX LLC
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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, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 2005
INDICATIONS AND USAGE
Fludeoxyglucose F18 Injection 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 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 2.6 mCi in the neurology setting(2.2).
In