FLUDEOXYGLUCOSE F 18- fludeoxyglucose f-18 injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hamamatsu/Queen’s PET Imaging Center, LLC

INN (International Name):

FLUDEOXYGLUCOSE F-18

Composition:

FLUDEOXYGLUCOSE F-18 100 mCi in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fludeoxyglucose F 18 Injection, USP is indicated in positron emission tomography (PET) imaging 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 diagnoses of cancer. Fludeoxyglucose F 18 Injection, USP is indicated in positron emission tomography (PET) imaging in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging, for the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function. Fludeoxyglucose F 18 Injection, USP is indicated in positron emission tomography (PET) imaging in patients for the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. None known

Product summary:

Fludeoxyglucose F 18 Injection, USP is supplied in a multi-dose septum capped 30 mL glass vial containing between 0.37 – 3.7 GBq/mL (10 - 100 mCi/mL), of no carrier added 2-deoxy-2 [18 F]fluoro-D-glucose, at end of synthesis, in approximately 24 mL. NDC# 76376 - 618- 30 This radiopharmaceutical is licensed by the Nuclear Regulatory Commission, for distribution to entities licensed pursuant to 10 CFR 35.200.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUDEOXYGLUCOSE F 18- FLUDEOXYGLUCOSE F-18 INJECTION, SOLUTION
HAMAMATSU/QUEEN’S PET IMAGING CENTER, LLC
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FLUDEOXYGLUCOSE F 18 INJECTION, USP, FOR INTRAVENOUS USE
DESCRIPTION
Fludeoxyglucose F 18 Injection, USP is a positron emitting
radiopharmaceutical containing no-carrier
added radioactive 2-deoxy-2-[
F]fluoro-D-g1ucose, which is used for diagnostic purposes
in conjunction with Positron Emission Tomography (PET). It is
administered by intravenous injection.
The active ingredient 2-deoxy-2-[
F]fluoro-D-g1ucose (Fludeoxyglucose F 18), abbreviated [
F]
FDG, has a molecular formula of C H
FO with a molecular weight of 181.26 Daltons, and has the
following chemical structure:
Fludeoxyglucose F 18 Injection, USP is provided as a ready to use
isotonic, sterile, pyrogen free,
clear, colorless citrate buffered solution. Each mL contains between
0.37 to 3.7 GBq (10.0 – 100
mCi) of 2-deoxy-2-[
F]fluoro-D glucose at the end of synthesis (EOS), 4.5 mg of sodium
chloride
and 7.2 mg of citrate ions. The pH of the solution is between 5.0 to
7.5. The solution is packaged in a
multiple-dose glass vial and does not contain any preservative.
PHYSICAL CHARACTERISTICS
Fluorine F 18 decays by positron (β ) emission and has a half-life of
109.7 minutes. The principal
photons useful for diagnostic imaging are the 511 keV gamma photons,
resulting from the interaction of
the emitted positron with an electron (Table 1).
TABLE 1. PRINCIPAL RADIATION EMISSION DATA FOR FLUORINE F 18
*
RADIATION/EMIS S ION
% PER DISINTEGRATION
MEAN ENERGY
Positron(β )
96.73
249.8 keV
Gamma(±)
193.46
511.0 keV
EXTERNAL RADIATION
The specific gamma ray constant for fluorine F 18 is 6.0 R/hr/mCi (0.3
Gy/hr/kB) at 1cm. The half-
value layer (HVL) for the 511 keV photons is 4.1 mm lead (Pb). A range
of values for the attenuation of
radiation results from the interposition of various thickness of Pb.
The range of attenuation coefficients
for this radionuclide is shown in Table 2. For example, the
interposition of an 8.3 mm thickness of Pb,
with a