NDA 21-870: FDG F 18 Injection Page 4 Fludeoxyglucose F 18 Injection Diagnostic – For Intravenous Use Only DESCRIPTION Fludeoxyglucose F 18 Injection is a positron emitting radiopharmaceutical...

2022年3月8日 · What Is Fludeoxyglucose F 18? Fludeoxyglucose F 18 Injection (fdg) is a positron emitting radiopharmaceutical used for diagnostic purposes in conjunction with Positron Emission Tomography (PET). Fludeoxyglucose F 18 Injection is used to assist assessment of cancer, coronary artery disease, or epileptic seizures.

Multiple-dose 30 mL and 50 mL glass vial containing 0.74 to 7.40 GBq/mL (20 to 200 mCi/mL) of Fludeoxyglucose F 18 Injection and 4.5 mg of sodium chloride with 0.1 to 0.5% w/w ethanol as a stabilizer (approximately 15 to 50 mL volume) for intravenous administration.

5 天之前 · Multiple-dose glass vial containing 0.74 GBq –11.1 GBq (20 mCi/mL–300 mCi/mL) of Fludeoxyglucose F18 Injection and 4.5 mg of sodium chloride in citrate buffer (approximately 20 mL volume), for intravenous administration ( 3).

2020年8月7日 · Fludeoxyglucose F18 Injection, USP is a positron emitting radiopharmaceutical containing no-carrier added radioactive 2-deoxy-2- [18F]fluoro-D-glucose that is used for diagnostic purposes in conjunction with Positron Emission Tomography (PET). It is administered by intravenous injection.

Lead shielded, glass vial contains sterile, colorless or light yellow, clear injectable solution of 2-(18F)-Fluoro-2-deoxy-D-glucose ((18F) FDG) Description MON.FDG (18F) is a radiopharmaceutical product used for diagnostic purposes. Fluorine-18 (18F) is a radionuclide with a half-life of 109.8 minutes, decays

2019年10月1日 · Fludeoxyglucose F 18 Injection is supplied in a multi-dose, capped 30 mL and 50 mL glass vial containing between 0.740 to 7.40 GBq/mL (20 to 200 mCi/mL), of no carrier added 2-deoxy-2-[18 F]-fluoro-D-glucose, at end of synthesis, in approximately 15 to 50 mL. The contents of each vial are sterile, pyrogen-free and preservative-free.

[18F]FDG is a glucose analogue which concentrates in cells that rely upon glucose as a primary energy source. Once in the cell it is phosphorylated and can not exit until dephosphorylation has occurred. Regions of “increased [18F]FDG uptake" correlate with increased glucose metabolism.

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 (10 mL vial: approximately 5-10 mL volume; 30 mL vial: approximately 10-30 mL volume) for intravenous administration.

2005年4月1日 · There are two methods for accurately dispensing [18 F]FDG into a vial. One method is to return the radioactivity in the extension tube, between the mother- and dispensing vials, to the mother vial after dispensing.