Fludeoxyglucose F18
Generic: FLUDEOXYGLUCOSE F-18
Basic Information
Manufacturer
Biomedical Research Foundation of Northwest Louisiana
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
edb15e3c-848d-433d-9f1c-c73a3c72861b
Indications & Usage
1 INDICATIONS AND USAGE Fludeoxyglucose F 18 Injection USP is indicated for positron emission tomography (PET) imaging in the following settings: FLUDEOXYGLUCOSE F 18 INJECTION USP 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.
Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures ( 1 ).
1.1 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.
1.2 Cardiology For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
1.3 Neurology For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.
Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures ( 1 ).
1.1 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.
1.2 Cardiology For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.
1.3 Neurology For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.
Adverse Reactions
6 ADVERSE REACTIONS Hypersensitivity reactions with pruritus, edema and rash have been reported in the post-marketing setting.
Have emergency resuscitation equipment and personnel immediately available.
Hypersensitivity reactions have occurred; have emergency resuscitation equipment and personnel immediately available ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Biomedical Research Foundation of Northwest Louisiana at 318-716-4000 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Have emergency resuscitation equipment and personnel immediately available.
Hypersensitivity reactions have occurred; have emergency resuscitation equipment and personnel immediately available ( 6 ).
To report SUSPECTED ADVERSE REACTIONS, contact Biomedical Research Foundation of Northwest Louisiana at 318-716-4000 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.