İHALE DÜNYASI
İHALE DÜNYASI
Fludeoxyglucose F18 Injection, USP is a positron emitting radiopharmaceutical containing no-carrier added radioactive 2-deoxy-2-[ 18 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-[ 18 F]fluoro-D-glucose, abbreviated [ 18 F]FDG, has a molecular formula of C 8 H 11 18 F0 8 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-[ 18 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. Fludeoxyglucose F-18
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.
[ 18 F]FDG uptake may be changed by fasting or by blood sugar changes associated with diabetic mellitus. Blood glucose levels should be stabilized in non-diabetic patients by fasting before [ 18 F]FDG injection. Diabetic patients may need stabilization of blood glucose on the day preceding and on the day of the [ 18 F]FDG scan. The recommended dose of [ 18 F]FDG for an adult (70 kg) is within the range 185-370 MBq (5-10 mCi), intravenous injection. In children doses as low as 2.6 mCi have been given. Optimal dose reductions for children have not been confirmed. The optimum rate of administration and upper safe dose for [ 18 F]FDG have not been established. The time interval between doses of [ 18 F]FDG should be long enough to allow substantial decay (physical and biological) of previous administrations. It is recommended that PET imaging be initiated within 40 minutes of [ 18 F]FDG injection. The final dose for the patient should be calculated using proper decay factors from the time of the EOS, and measured by a suitable radioactivity calibration system before administration. See decay factors in Table 3. [ 18 F]FDG, like other parenteral drug products, should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit. Preparations containing particulate matter or discoloration should not be administered. They should be disposed of in a safe manner, in compliance with applicable regulations. [ 18 F]FDG should be stored upright in a lead shielded environment at controlled room temperature. Aseptic techniques and effective shielding should be employed in withdrawing doses for administration to patients. Waterproof gloves and effective shielding should be worn when handling the product.
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The [ 18 F]FDG safety data base was evaluated for 374 patients. Of these, 245 were male and 105 were female. For 24 patients, gender was not specified. The mean age was 47.8 years (range under 2 to over 65 years). Eighteen patients were between the age of 0 and 2 years; 42 patients were between the ages of 2 and 21 years old; 213 patients were between 21 and 65 years old and 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 that required medical intervention were not reported. In a small, 42 patient subset of the 374 patients studied, 4 patients had transient hypotension, 6 had hypo- or hyperglycemia and 3 had transient increases in alkaline phosphatase.
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