FLUDEOXYGLUCOSE F-18- fludeoxyglucose f-18 injection injection

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:

University of North Dakota

INN (International Name):

Fludeoxyglucose F-18

Composition:

Fludeoxyglucose F-18 500 mCi in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Fludeoxyglucose F 18 Injection,USP is indicated in PET (positron emission tomography) for: 1. Identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures. 2. 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. 3. Assessment of 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 not indicated for distinguishing epileptogenic foci from brain tumors or other brain lesions which may cause seizures. None known

Product summary:

NDC 24468-001-10 Fludeoxyglucose F18 Injection, USP is supplied in a multi-dose, septum capped 10 mL glass vial containing between 148 - 1480 MBq/mL (4 — 500 mCi/mL) of no carrier added 2-deoxy-2-[ 18 F]fluoro-D-glucose at end of synthesis, in approximately 6 mL. This radiopharmaceutical is licensed by the North Dakota Department of Health for distribution to persons authorized to receive the licensed material pursuant to the terms and conditions of a specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement State. [ 18 F]FDG should be stored upright in a lead shielded container at controlled room temperature. Storage and disposal of [ 18 F]FDG should be in accordance with the regulations and a specific license issued by the U.S. Nuclear Regulatory Commission or an Agreement State. Fludeoxyglucose F18 Injection, USP should be used within 12 hours from the end of synthesis, which is provided on the container label. Caution: Federal Law Prohibits Dispensing Without Prescription. Manufactured by: University of North Dakota Cyclotron and Positron Operations 501 N Columbia Rd., Grand Forks, ND 58203

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUDEOXYGLUCOSE F-18- FLUDEOXYGLUCOSE F-18 INJECTION INJECTION
UNIVERSITY OF NORTH DAKOTA
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DESCRIPTION
Fludeoxyglucose F18 Injection, USP is a positron emitting
radiopharmaceutical containing no-carrier
added radioactive 2-deoxy-2-[
F]fluoro-D-glucose that 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-glucose, abbreviated [
F]FDG, has a molecular
formula of C
H
F0
with a molecular weight of 181.26 daltons, and has the following
chemical
structure:
Fludeoxyglucose F18 Injection, USP is provided as a ready to use
sterile, pyrogen free, clear,
colorless solution. Each milliliter contain between 150 to 1850 MBq (4
— 500 mCi) of 2-deoxy-2-[
F]fluoro-D-glucose at the end of synthesis (EOS), and 9 mg of sodium
chloride in citrate buffer. The
pH of the solution is between 4.5 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 ( +) emission and has a half life of
110 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. PRINCIPLE EMISSION DATA FOR FLUORINE F-18
Radiation/Emission
% Per Disintigration
Mean Energy
Positron (+)
96.73
249.8 keV
Gamma (+/-)*
193.46
511.0 keV
*Produced by positron annihilation
From: Kocher, D.C. "Radioactive Decay Tables" DOE/TIC-11026, 89
(1981).
EXTERNAL RADIATION
18
18
18
8
11
18
8
18
The specific gamma ray constant for Fluorine F 18 is 6.0 R/hr/mCi (0.3
Gy/hr/kBq) 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 thicknesses 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 coefficient of
at