Fludeoxyglucose F 18 300 mCi/mL
Fludeoxyglucose F-18 · INJECTION · SOFIE Co.
Fludeoxyglucose F 18 is a injection containing fludeoxyglucose f-18 at 300 mCi/mL, taken intravenous. Manufactured by SOFIE Co..
Key Facts
- Brand Name
- Fludeoxyglucose F 18
- Generic Name
- Fludeoxyglucose F-18
- NDC Code (Product)
49609-101- Manufacturer
- SOFIE Co.
- Strength
- 300 mCi/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA203591
- Drug Class
- Radioactive Diagnostic Agent [EPC]
- Marketing Start
- 12/08/2011
Recall History
Petnet Solution Inc
cGMP Deviation
The General Hospital Corporation
Lack of Assurance of Sterility
Lantheus MI Radipharmaceuticals Inc.
Failed Impurities/Degradation Specifications; out of specification result for Acetonitrile residual solvent
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
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 ( 1 ). • 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 ). • 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 ventri…
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Fludeoxyglucose F-18 Injection emits radiation. Use procedures to minimize radiation exposure. Calculate the final dose from the end of synthesis (EOS) time using proper radioactive decay factors. Assay the final dose in a properly calibrated dose calibrator before administration to the patient [ see Description ( 11.2 ) ]. Fludeoxyglucose F-18 Injection emits radiation. Use procedures to minimize radiation exposure. Screen for blood glucose abnormalities. • In the oncology and neurology settings, instruct patients to fast for 4 – 6 hours prior to the drug’s injection. Consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to the drug’s administration ( 5.2 ). • In the cardiology setting, administration of glucose-containing food or liquids (e.g., 50 – 75 grams) prior to the drug’s injection facilitates localization of cardiac ischemia ( 2.3 ). Aseptically withdraw Fludeoxyglucose F-18 Injection from its container and administer by intravenous injection ( 2 ). The recommended dose: • for adults is 5 – 10 mCi (185 – 370 MBq), in all indicated clinical settings ( 2.1 ). • for pediatric patients is 2.6 mCi in the …
Contraindications
4 CONTRAINDICATIONS None None ( 4 )
Drug Interactions
7 DRUG INTERACTIONS The possibility of interactions of Fludeoxyglucose F-18 Injection with other drugs taken by patients undergoing PET imaging has not been studied.
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 Cardinal Health at 1-800-618-2768 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Frequently Asked Questions
What is Fludeoxyglucose F 18 used for?
Fludeoxyglucose F 18 contains Fludeoxyglucose F-18. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Fludeoxyglucose F 18 a controlled substance?
Fludeoxyglucose F 18 is not classified as a controlled substance by the DEA.
What is the generic name for Fludeoxyglucose F 18?
The generic name for Fludeoxyglucose F 18 is Fludeoxyglucose F-18. There are 6 other brand versions of Fludeoxyglucose F-18.
What is the NDC code for Fludeoxyglucose F 18 300 mCi/mL?
The NDC (National Drug Code) for Fludeoxyglucose F 18 300 mCi/mL is 49609-101, listed by SOFIE Co..