Fludeoxyglucose F 18
Generic: FLUDEOXYGLUCOSE F-18
Basic Information
Manufacturer
BAMF Health Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
347c6beb-499e-af61-e063-6394a90a6011
Indications & Usage
1 INDICATIONS AND USAGE Fludeoxyglucose F 18 Injection is indicated for positron emission tomography (PET) imaging in the following settings: 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.
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.
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.
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 BAMF Health at 1-616-272-5777 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 BAMF Health at 1-616-272-5777 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .