Indications and Safety Information

PET/CT imaging is a safe, noninvasive nuclear medicine or molecular imaging procedure.

Radiopharmaceuticals are approved by the Food and Drug Administration and prepared with great care. They are tested carefully prior to general use. Nuclear imaging has been used for more than five decades and side effects are rare. While exposure to radiation does involve risk, naturally occurring background radiation and activities such as watching television and flying in an airplane all contribute to a lifetime exposure that is only slightly increased by medical imaging. Your physician has determined that the benefits of early and accurate diagnosis outweigh the risk of exposure to this small quantity of radioactive material.

Indications and Important Safety Information
FLUDEOXYGLUCOSE F 18 INJECTION, USP
For Intravenous Use

INDICATIONS AND USAGE
Fludeoxyglucose F 18 Injection is indicated for positron emission tomography (PET) imaging in the following settings:

Oncology: For 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.

IMPORTANT SAFETY INFORMATION
Radiation Risk:
Radiation-emitting products, including Fludeoxyglucose F 18 Injection, may increase the risk for cancer, especially in pediatric patients. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker.

Blood Glucose Levels: 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 administration.

ADVERSE REACTIONS
Hypersensitivity reactions with pruritis, edema and rash have occurred; have emergency resuscitation equipment and personnel immediately available.

Click here to view the full prescribing information for Fludeoxyglucose F 18 Injection

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