Fdg Indications, Dosage, Storage, Stability - Fluorodeoxyglucose F18 Inj

Fdg Indications, Dosage, Storage, Stability - Fluorodeoxyglucose F18 Inj

INDICATIONS AND USAGE

Fluorodeoxyglucose F 18 Injection ([18F]FDG) is indicated in PET (positron emission tomography) for the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.

Fluorodeoxyglucose F 18 Injection is not indicated for distinguishing epileptogenic foci from brain tumors or other brain lesions which may cause seizures.

DOSAGE AND ADMINISTRATION

[18F]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 [18F]FDG injection. Diabetic patients may need stabilization of blood glucose on the day preceding and on the day of the [18F]FDG scan.

The recommended dose of [18F]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 [18F]FDG have not been established. The time interval between doses of [18F]FDG should be long enough to allow substantial decay (physical and biological) of previous administrations.

It is recommended that imaging be initiated within 60-90 minutes of [18F]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.

[18F]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.

[18F]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.

HOW SUPPLIED

NDC TBS

[18F]FDG for intravenous administration is supplied in a multiple-dose, 10-30 ml, septum-capped glass vial. The vial contains 680-10000 mCi of 2-Deoxy-2-[18F]fluoro- D -glucose, at end of synthesis (SOS), in a volume of 10-30 ml of isotonic saline.

[18F]FDG has a concentration of radioactivity of 68-357 mCi/ml and a specific activity of no less than 11 Ci/mmol at end of bombardment.

Fluorodeoxyglucose F 18 Injection is a cyclotron-produced radioactive material which is not licensed by the US Nuclear Regulatory Commission.

Storage

[18F]FDG should be stored upright in a lead shielded container at controlled room temperature.

Storage and disposal of [18F]FDG should be in accordance with the regulations and a general license, 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. [18F]FDG should be used within 12 hours from the time of the end of synthesis (EOS).

Caution: Federal Law Prohibits Dispensing Without Prescription

Manufactured by: Eastern isotopes, Inc., 100 Executive Dr Sterling VA USA, Revision Date March 08, 2001