Fludeoxyglucose F 18 Injection, USP is a positron emitting radiopharmaceutical containing no-carrier added radioactive 2-deoxy-2-[18F]fluoro-D-g1ucose, which is used for diagnostic purposes inconjunction with Positron Emission Tomography (PET). It is administered by intravenousinjection.
The active ingredient 2-deoxy-2-[18F]fluoro-D-g1ucose (Fludeoxyglucose F 18), abbreviated[18F] FDG, has a molecular formula of C6H1118FO5 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-[18F]fluoro-D glucose at the end of synthesis (EOS), 4.5 mg of sodium chloride and7.2 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. Theprincipal photons useful for diagnostic imaging are the 511 keV gamma photons, resultingfrom the interaction of the emitted positron with an electron (Table 1).
| ||
| Radiation/Emission | % 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 theattenuation of radiation results from the interposition of various thickness of Pb. The range ofattenuation coefficients for this radionuclide is shown in Table 2. For example, the interpositionof an 8.3 mm thickness of Pb, with a coefficient of attenuation of 0.25, will decrease the externalradiation by 75%.
| Shield thickness (Pb) mm | Coefficient of attenuation |
| 0 | 0.00 |
| 4.1 | 0.50 |
| 8.3 | 0.25 |
| 13.2 | 0.10 |
| 26.4 | 0.01 |
| 52.8 | 0.001 |
For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 3.
| |
| Minutes | Fraction Remaining |
| 0* | 1.000 |
| 15 | 0.909 |
| 30 | 0.826 |
| 60 | 0.683 |
| 110 | 0.500 |
| 220 | 0.250 |
| 440 | 0.060 |
Mechanism of Action
Fludeoxyglucose F 18 is a glucose analog that concentrates in cells that rely upon glucose as an energy source, or in cells whose dependence on glucose increases under pathophysiologicalconditions. Fludeoxyglucose F 18 is transported through the cell membrane by facilitative glucosetransporter proteins and is phosphorylated within the cell to [18F] FDG-6- phosphate by the enzymehexokinase. Once phosphorylated it cannot exit until it is dephosphorylated by glucose-6-phosphatase.Therefore, within a given tissue or pathophysiological process, the retention and clearance ofFludeoxyglucose F 18 reflect a balance involving glucose transporter, hexokinase and glucose-6-phosphatase activities. When allowance is made for the kinetic differences between glucose andFludeoxyglucose F 18 transport and phosphorylation (expressed as the “lumped constant” ratio),Fludeoxyglucose F 18 is used to assess glucose metabolism.
In comparison to background activity of the specific organ or tissue type, regions of decreased orabsent uptake of Fludeoxyglucose F 18 reflect the decrease or absence of glucose metabolism.Regions of increased uptake of Fludeoxyglucose F 18 reflect greater than normal rates of glucose metabolism.
Pharmacodynamics
Fludeoxyglucose F 18 Injection is rapidly distributed to all organs of the body after intravenousadministration. After background clearance of Fludeoxyglucose F 18 Injection, optimal PETimaging is generally achieved between 30 to 40 minutes after administration.
In cancer, the cells are generally characterized by enhanced glucose metabolism partially due to(1) an increase in the activity of glucose transporters, (2) an increased rate of phosphorylation activity, (3) a reduction of phosphatase activity or, (4) a dynamic alteration in the balance among all theseprocesses. However, glucose metabolism of cancer as reflected by Fludeoxyglucose F 18accumulation shows considerable variability. Depending on tumor type, stage, and location,Fludeoxyglucose F 18 accumulation may be increased, normal, or decreased. Also, inflammatory cells can have the same variability of uptake of Fludeoxyglucose F 18.
In the heart, under normal aerobic conditions, the myocardium meets the bulk of its energy requirements by oxidizing free fatty acids. Most of the exogenous glucose taken up by the myocyteis converted into glycogen. However, under ischemic conditions, the oxidation of free fatty acidsstimulated,and glucose taken up by the myocyte is metabolized immediately instead of being converted intoglycogen. Under these conditions, phosphorylated Fludeoxyglucose F 18 accumulates in the myocyteand can be detected with PET imaging.
Normally, the brain relies on anaerobic metabolism. In epilepsy, the glucose metabolism varies.Generally, during a seizure, glucose metabolism increases. Interictally, the seizure focus tends to behypometabolic.
Pharmacokinetics
In four healthy male volunteers, receiving an intravenous administration of 30 seconds in duration, the arterial blood level profile for Fludeoxyglucose F 18 was described as a triexponential decay curve.The effective half-life ranges of the three phases were 0.2-0.3 minutes, 10-13 minutes with a mean andstandard deviation (STD) of 11.6 ± 1.1 min, and 80-95 minutes with a mean and STD of 88 ±□ 4 min.
Plasma Protein Binding
The extent of binding of Fludeoxyglucose F 18 to plasma proteins is not known.
Metabolism
Fludeoxyglucose F 18 is transported into cells and phosphorylated to [18F]-FDG-6-phosphate at a rate proportional to the rate of glucose utilization within that tissue.[18F]-FDG-6-phosphate presumably is metabolized to 2-deoxy-2-[18F]fluoro-6-phospho-D-mannose([18F]FDM-6-phosphate).
Fludeoxyglucose F 18 Injection may contain several impurities (e.g., 2-deoxy-2-chloro-D-glucose (ClDG)).Biodistribution and metabolism of C1DG are presumed to be similar to Fludeoxyglucose F 18 and would beexpected to result in intracellular formation of 2-deoxy-2-chloro-6-phospho-D-glucose (C1DG-6-phosphate)and 2-deoxy-2-chloro-6-phospho-D-mannose (ClDM-6-phosphate). The phosphorylated deoxyglucosecompounds are dephosphorylated and the resulting compounds (FDG, FDM, C1DG, and ClDM) presumablyleave cells by passive diffusion.
Fludeoxyglucose F 18 and related compounds are cleared from non-cardiac tissues within3 to 24 hours after administration. Clearance from the cardiac tissue may require more than96 hours.
Fludeoxyglucose F 18 that is not involved in glucose metabolism in any tissue is then excreted in theurine.
Excretion
Fludeoxyglucose F 18 is cleared from most tissues within 24 hours and can be eliminated from the body unchanged in the urine. Three elimination phases have been identified in the reviewed literature.Within 33 minutes, a mean of 3.9% of the administrated radioactive dose was measured in the urine.The amount of radiation exposure of the urinary bladder at two hours post-administration suggests that20.6% (mean) of the radioactive dose was present in the bladder.
Pharmacokinetics in Special Populations
Extensive dose range and dose adjustment studies with this drug product in normal and specialpopulations have not been completed. In pediatric patients with epilepsy, doses given have been as low as 2.6 mCi.
The pharmacokinetics of Fludeoxyglucose F 18 Injection in renally-impaired patients have not beencharacterized. Fludeoxyglucose F 18 is eliminated through the renal system. Care should be taken toprevent excessive and unnecessary radiation exposure to this organ system and adjacent tissues. Theeffects of fasting, varying blood sugar levels, conditions of glucose intolerance, and diabetes mellituson Fludeoxyglucose F 18 distribution in humans have not been ascertained. Diabetic patients mayneed stabilization of blood glucose levels on the day before and on the day of the FludeoxyglucoseF 18 Injection study.
Drug-Drug Interactions
Drug-drug interactions with Fludeoxyglucose F 18 Injection have not been evaluated.
Oncology:1 The efficacy of Fludeoxyglucose F 18 Injection in positron emission tomography cancer imaging was demonstrated in 16 independent literature reports. These studies prospectively evaluatedthe sensitivity and specificity of Fludeoxyglucose F 18 for detecting malignancies. All these studieshad at least 50 patients and used pathology as a standard of truth to compare the results of PETimaging with Fludeoxyglucose F 18 Injection. The studies encompassed a variety of cancers:non-small cell lung cancer, colo-rectal, pancreatic, breast, thyroid, melanoma, Hodgkin’s andnon-Hodgkin’s lymphoma, and various types of metastatic cancers to lung, liver, bone, and axillarynodes. The doses in the studies ranged from 200 MBq to 740 MBq with a median and mean dose of370 MBq.
In these studies the patients had a clinical reason for the evaluation of malignancy (e.g., the patients had an abnormality identified by a prior test and were seeking a diagnosis, or thepatients had an existing diagnosis of cancer and were having further work-up or monitoring).None of these studies evaluated the use of Fludeoxyglucose F 18 Injection in routine populationscreening in which healthy, asymptomatic people are tested for purposes of cancer earlydetection. The efficacy of Fludeoxyglucose F 18 PET imaging in cancer screening, including itsability to decrease cause-specific mortality, is unknown.
In PET imaging with Fludeoxyglucose F 18 Injection, sensitivity is restricted by the biologicvariability of cancer glucose utilization found in individual patients, with different cancers (seeClinical Pharmacology and Pharmacodynamic sections). In the reviewed studies, the sensitivityand specificity varied with the type of cancer, size of cancer, and other clinical parameters.Also, there were false negatives and false positives. Negative PET imaging results withFludeoxyglucose F 18 Injection do not preclude the diagnosis of cancer and further work-up is indicated. Also, positive PET imaging results with Fludeoxyglucose F 18 Injection cannotreplace biopsy to confirm a diagnosis of cancer. There are non-malignant conditions such asfungal infections, inflammatory processes, and benign tumors that had patterns of increasedglucose metabolism that give rise to false-positive examinations.
Cardiology:2 The efficacy of Fludeoxyglucose F 18 Injection for cardiac use was demonstratedin ten independent literature reports, which, in general, shared the characteristics summarizedbelow. The studies were prospective and enrolled patients with coronary artery disease andchronic left ventricular systolic dysfunction of a mild to moderate degree. The patients werescheduled to undergo coronary revascularization with either coronary artery bypass surgery orangioplasty. Before revascularization, patients underwent PET imaging with FludeoxyglucoseF 18 Injection and perfusion imaging with other diagnostic radiopharmaceuticals. Doses ofFludeoxyglucose F 18 Injection ranged from 74-370 MBq (2-10 mCi). Segmental, left ventricular, wall-motion assessments of asynergic areas made before revascularization werecompared to those made after successful revascularization to identify myocardial segments withfunctional recovery. Segmental wall motion assessments were made blinded to the results ofmetabolic/perfusion imaging, and PET image analyses were quantitative.
Left ventricular myocardial segments were predicted to have reversible loss of systolic functionif they showed Fludeoxyglucose F 18 accumulation and reduced perfusion (i.e., flow-metabolismmismatch). Conversely, myocardial segments were predicted to have irreversible loss of systolicfunction if they showed concordant reductions in both Fludeoxyglucose F 18 accumulation andperfusion (i.e., matched defects). Diagnostic performance measures such as sensitivity,specificity, positive predictive value, and negative predictive value were calculated. None of thestudies prospectively determined the degree to which mismatch, or the location of mismatch,is associated with improvements in global ventricular function, clinical symptoms, exercisetolerance, or survival.
Findings of flow-metabolism mismatch in a myocardial segment suggest that successfulrevascularization will restore myocardial function in that segment. However, false-positive testsoccur regularly, and the decision to have a patient undergo revascularization should not be basedon PET findings alone. Similarly, findings of a matched defect in a myocardial segment suggestthat myocardial function will not recover in that segment, even if it is successfully revascularized.However, false-negative tests occur regularly, and the decision to recommend against coronary revascularization, or to recommend a cardiac transplant, should not be based on PET findings alone.The reversibility of segmental dysfunction as predicted with Fludeoxyglucose F 18 PET imagingdepends on successful coronary revascularization. Therefore, in patients with a low likelihood ofsuccessful revascularization, the diagnostic usefulness of PET imaging with Fludeoxyglucose F 18Injection is limited.
Epilepsy:3In a prospective, open label trial, Fludeoxyglucose F 18 Injection was evaluated in86 patients with epilepsy. Each patient received a dose of Fludeoxyglucose F 18 Injection in therange of 185-370 MBq (5-10 mCi). Demographic characteristics of race and gender are notavailable. The mean age was 16.4 years (range: 4 months - 58 years; of these, 42 patients were<12 years and 16 patients were <2 years old). Patients had a known diagnosis of complex partial epilepsy and were under evaluation as surgical candidates for treatment of their seizure disorder.Seizure foci had been previously identified on ictal EEGs and sphenoidal EEGs. In 16% (14/87) of patients, the pre-Fludeoxyglucose F 18 Injection findings were confirmed by FludeoxyglucoseF 18; 34% (30/87) of patients, images of Fludeoxyglucose F 18 Injection provided new findings.In 32% (27/87), imaging with Fludeoxyglucose F 18 Injection was not definitive. The influence of these findings on surgical outcome, medical management, or behavior is not known.
Several other studies comparing imaging with Fludeoxyglucose F 18 Injection results to subsphenoidalEEG, MRI and/or surgical findings supported the concept that the degree of hypometabolismcorresponds to areas of confirmed epileptogenic foci.
The safety and effectiveness of Fludeoxyglucose F 18 Injection to distinguish idiopathicepileptogenic foci from tumors or other brain lesions that may cause seizures have not beenestablished.
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 patientswith known or suspected abnormalities found by other testing modalities, or in patients with anexisting 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 withmyocardial perfusion imaging, for the identification of left ventricular myocardium with residualglucose metabolism and reversible loss of systolic function.
Fludeoxyglucose F 18 Injection, USP is indicated in positron emission tomography (PET) imaging inpatients for the identification of regions of abnormal glucose metabolism associated with foci ofepileptic seizures.
None known
None known
General
Use in patients with diabetes mellitus or hyperglycemia has not been well studied. It is recommended that patients be normoglycemic when undergoing PET imaging with Fludeoxyglucose F 18 Injection.
Radiopharmaceuticals should be used only by physicians who are qualified by specific training in thesafe use and handling of radionuclides (See Drug Handling section).
Information for Patients
To minimize radiation-absorbed dose to the bladder, adequate hydration should be encouraged to permit frequent voiding during the first few hours after intravenous administration ofFludeoxyglucose F 18 Injection. This may be achieved by having patients drink at least an 8 oz.glass of water prior to drug administration. To help protect themselves and others in theirenvironment, patients should take the following precautions for 12 hours after injection:whenever possible, a toilet should be used and should be flushed several times after each use andhands should be washed thoroughly after each voiding or fecal elimination. If blood, urine orfeces soil clothing, the clothing should be washed separately.
Diabetic Patients
Transport of Fludeoxyglucose F 18 into cells may be affected by fasting or by blood glucosechanges associated with diabetes mellitus. Diabetic patients may need stabilization of bloodglucose levels on the day before and on the day of administration of Fludeoxyglucose F 18Injection.
Carcinogenesis, Mutagenesis, Impairment or Fertility
Studies with Fludeoxyglucose F 18 Injection have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.
Teratogenic Effects: Pregnancy Category C
Animal reproduction studies have not been conducted with Fludeoxyglucose F 18 Injection. It isnot known whether Fludeoxyglucose F 18 Injection can cause fetal harm when administered to apregnant woman or can affect reproduction capacity. Therefore, Fludeoxyglucose F 18 Injectionshould be given to a pregnant woman only if clearly indicated.
Nursing Mothers
It is not known whether Fludeoxyglucose F 18 Injection is excreted in human milk. Caution should beexercised when Fludeoxyglucose F 18 Injection is administered to a lactating woman.
Pediatric Use
The safety and effectiveness of Fludeoxyglucose F 18 Injection in pediatric patients withepilepsy is established on the basis of studies in adult and pediatric patients. In pediatrics, therecommended dose is 2.6 mCi. The optimal dose adjustment on the basis of body size or weighthas not been determined.
The safety and effectiveness of Fludeoxyglucose F 18 Injection for the evaluation of malignancyor for the identification of left ventricular myocardium with reversible loss of systolic function in pediatric patients below the age of 16 years have not been established.
See Clinical Trials section.
The Fludeoxyglucose F 18 Injection safety database for epilepsy included of 374 patients. Ofthese, 245 were male and 105 were female. For 24 patients, gender was not specified. The meanage was 47.8 years (range under 2 to over 65 years). Eighteen patients were between the age of0 and 2 years; 42 patients were between the ages of 2 and 21 years; 213 patients were between21 and 65 years; 98 patients were older than 65 years; and the ages of 3 male patients were not specified. A racial distribution is not available. In this database, adverse drug reactions thatrequired medical intervention were not reported. In a small, 42 patient subset of the 374 patientsstudied, 4 patients had transient hypotension, 6 had hypo- or hyperglycemia and 3 had transientincreases in alkaline phosphatase.
Reviews of the oncology and cardiology literature did not reveal reported adverse reactions.
The recommended dose of Fludeoxyglucose F 18 Injection for an adult (70 kg) is 185-370 MBq(5-10 mCi), as an intravenous injection for studies of malignancy, cardiology, and epilepsy.
In general, Fludeoxyglucose F 18 Injection should be administered after patients have fasted for4-6 hours. For cardiac use, Fludeoxyglucose F 18 Injection may be administered either to patients who have fasted or to patients who have received a glucose load (See PatientPreparation section).
The optimum rates of administration and upper safe dose for Fludeoxyglucose F 18 Injectionhave not been established. The time interval between doses of Fludeoxyglucose F 18 Injectionshould be long enough to allow substantial decay (physical and biological) of previousadministrations.
The final dose for the patient should be calculated using proper decay factors from the time ofthe end of synthesis (EOS), and measured by a suitable radioactivity calibration system beforeadministration. See decay factors in Table 3.
Patient Preparation: Blood glucose levels should be stabilized before Fludeoxyglucose F 18Injection is administered. In non-diabetic patients this may be accomplished by fasting 4-6 hours before Fludeoxyglucose F 18 Injection. Diabetic patients may need stabilization of blood glucose onthe day preceding and on the day of administration of Fludeoxyglucose F 18 Injection.
For cardiac imaging, administration of Fludeoxyglucose F 18 Injection to fasting patients limitsthe accumulation of Fludeoxyglucose F 18 to ischemic myocardium. This may make localization ofthe ischemic region difficult because the surrounding myocardium will not be well visualized.Conversely, administration of Fludeoxyglucose F 18 Injection to patients who have received a glucoseload (e.g., 50-75 grams, 1-2 hours before administration of Fludeoxyglucose F 18 Injection) allows thesurrounding, non-ischemic myocardium to be seen and facilitates localization of ischemic areas.
Imaging: Optimally, it is recommended that positron emission tomography (PET) imaging beinitiated within 40 minutes of administration of Fludeoxyglucose F 18 Injection.
Static emission scans are acquired 30-100 minutes from time of injection.
Overdoses of Fludeoxyglucose F 18 Injection have not been reported. See Radiation Dosimetrysection for related information.
Fludeoxyglucose F 18 Injection, USP, like other parenteral drugs, should be inspected visually for particulate matter and discoloration before administration, whenever solution and containerpermit. Fludeoxyglucose F 18 Injection preparations containing particulate matter ordiscoloration should not be administered. They should be disposed of in a safe manner, incompliance with applicable regulations.
Aseptic techniques and effective shielding should be employed in withdrawing doses foradministration to patients. Waterproof gloves and effective shielding should be worn whenhandling the product.
The contents of each vial are sterile and non-pyrogenic. To maintain sterility, aseptic techniquemust be used during all operations involved in the manipulation and administration ofFludeoxyglucose F 18 Injection, USP.
Fludeoxyglucose F 18 Injection, USP should be used within 12 hours of the end of synthesis (EOS).
As with any other radioactive material, appropriate shielding should be used to avoidunnecessary radiation exposure to the patient, occupational workers, and other persons.Fludeoxyglucose F 18 Injection, USP, like other radioactive drugs, must be handled with care and appropriate safety measures should be used to minimize radiation exposure to clinical personnel.Care should be taken to minimize exposure to the patient consistent with proper patient management. Radiopharmaceuticals should be used by or under the control of physicians who are qualified byspecific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the useof radionuclides.
The estimated human absorbed radiation doses (rem/mCi) to a 1-year old (9.8 kg), 5-year old(19 kg), 10-year old (32 kg), 15-year old (57 kg), and adult (70 kg) from intravenous administration of Fludeoxyglucose F 18 Injection are shown in Table 4. These estimates were calculated based on human4 data and using the data published by the International Commission on RadiologicalProtection5 for Fludeoxyglucose F 18. The dosimetry data obtained and presented in this table showthat there are slight variations in absorbed radiation dose for various organs in each of the age groups.These dissimilarities in absorbed radiation dose are understood to be due to developmental agevariations (e.g., organ size, location, and overall metabolic rate for each age group). The identifiedcritical organs (in descending order) across all age groups evaluated (i.e., newborn, 1, 5, 10, 15 year(s)and adults) are the urinary bladder, heart, pancreas, spleen, and lungs. The absolute values for absorbedradiation in each of these organs vary in each of the age groups.
| ||||||
| Organ | Newborn* (3.4 kg) | 1-year old* (9.8 kg) | 5-year old* (19 kg) | 10-year old* (32 kg) | 15-year old* (57 kg) | Adult* (70 kg) |
| Bladder wall† | 4.3 | 1.7 | 0.93 | 0.60 | 0.40 | 0.32 |
| Heart wall | 2.4 | 1.2 | 0.70 | 0.44 | 0.29 | 0.22 |
| Pancreas | 2.2 | 0.68 | 0.33 | 0.25 | 0.13 | 0.096 |
| Spleen | 2.2 | 0.84 | 0.46 | 0.29 | 0.19 | 0.14 |
| Lungs | 0.96 | 0.38 | 0.20 | 0.13 | 0.092 | 0.064 |
| Kidneys | 0.81 | 0.34 | 0.19 | 0.13 | 0.089 | 0.074 |
| Ovaries | 0.80 | 0.8 | 0.19 | 0.11 | 0.058 | 0.053 |
| Uterus | 0.79 | 0.35 | 0.19 | 0.12 | 0.076 | 0.062 |
| LLI wall | 0.69 | 0.28 | 0.15 | 0.097 | 0.060 | 0.051 |
| Liver | 0.69 | 0.31 | 0.17 | 0.11 | 0.076 | 0.058 |
| Gallbladder wall | 0.69 | 0.26 | 0.14 | 0.093 | 0.059 | 0.049 |
| Small intestine | 0.68 | 0.29 | 0.15 | 0.096 | 0.060 | 0.047 |
| ULI wall | 0.67 | 0.27 | 0.15 | 0.090 | 0.057 | 0.046 |
| Stomach wall | 0.65 | 0.27 | 0.14 | 0.089 | 0.057 | 0.047 |
| Adrenals | 0.65 | 0.28 | 0.15 | 0.095 | 0.061 | 0.048 |
| Testes | 0.64 | 0.27 | 0.14 | 0.085 | 0.052 | 0.041 |
| Red marrow | 0.62 | 0.26 | 0.14 | 0.089 | 0.057 | 0.047 |
| Thymus | 0.61 | 0.26 | 0.14 | 0.086 | 0.056 | 0.044 |
| Thyroid | 0.61 | 0.26 | 0.13 | 0.080 | 0.049 | 0.039 |
| Muscle | 0.58 | 0.25 | 0.13 | 0.078 | 0.049 | 0.039 |
| Bone surface | 0.57 | 0.24 | 0.12 | 0.079 | 0.052 | 0.041 |
| Breast | 0.54 | 0.22 | 0.11 | 0.068 | 0.043 | 0.034 |
| Skin | 0.49 | 0.20 | 0.10 | 0.060 | 0.037 | 0.030 |
| Brain | 0.29 | 0.13 | 0.09 | 0.078 | 0.072 | 0.070 |
| Other tissues | 0.59 | 0.25 | 0.13 | 0.083 | 0.052 | 0.042 |
- See March 10, 2000 Federal Register, Docket No. 00N-0553, pp. 12999-13010
- See March 10, 2000 Federal Register, Docket No. 00N-0553, pp. 12999-13010
- See NDA #020306
- Jones, S. C., A. Alavi, Christman, D., Montanez, I., Wolf, A.P. and Reivich, M. (1982).“The Radiation Dosimetry of 2-F-18 fluoro-2-deoxyglucose in Man”. J. Nucl. Me d. 23, 613-617.
- ICRP Publication 53,Volume 18, No. l, 1987, page 76
Fludeoxyglucose F 18 Injection, USP is supplied in a multi-dose septum capped 30 mL glassvial containing between 0.37 – 3.7 GBq/mL (10 - 100 mCi/mL), of no carrier added 2-deoxy-2 [18F]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.
Store Fludeoxyglucose F 18 Injection, USP at 25°C (77°F); excursions permitted to 15-30°C (59-86°F).
Store Fludeoxyglucose F 18 Injection, USP multiple-dose vial upright in a lead shielded container.
Store and dispose of Fludeoxyglucose F 18 Injection, USP in accordance with the regulations and a generallicense, or its equivalent, of an Agreement State or a Licensing State.
Expiration Date and Time
The expiration date and time are provided on the container label. Fludeoxyglucose F 18Injection,USP should be used within 12 hours from the time of the end of synthesis (EOS).
Caution: Federal Law Prohibits Dispensing Without Prescription
Manufactured and Distributed by:
Hamamatsu/Queen’s PET Imaging Center, LLC
1301 Punchbowl Street
Honolulu, HI 96813
NDC# 76376-618-30
30 mL Multiple-Dose Vial
Fludeoxyglucose F 18 Injection, USP
