Fludeoxyglucose F 18

For the identification of regions of abnormal
glucose metabolism associated with foci of epileptic seizures.

• Initiate
  imaging within 40 minutes following Fludeoxyglucose F 18 Injection
  administration.
• Acquire
  static emission images 30 – 100 minutes from the time of injection.

Multiple-dose glass vial containing 0.74 - 11.1GBq (20 - 300 mCi/mL) of Fludeoxyglucose F 18 Injection and 4.5 mg of sodium chloride in citrate buffer (approximately 25 - 30 mL volume) for intravenous administration.

The safety and effectiveness of Fludeoxyglucose F 18 Injection in pediatric patients with epilepsy is established on the basis of studies in adult and pediatric patients. In pediatric patients with epilepsy, the recommended dose is 2.6 mCi. The optimal dose adjustment on the basis of body size or weight has not been determined.

In the oncology or cardiology settings, the safety and effectiveness of Fludeoxyglucose F 18 Injection have not been established in pediatric patients.

In
the oncology and neurology setting, suboptimal imaging may occur in patients
with inadequately regulated blood glucose levels.  In these patients, consider medical therapy
and laboratory testing to assure at least two days of normoglycemia prior to Fludeoxyglucose
F 18 Injection administration.