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These highlights do not include all the information needed to use Fludeoxyglucose F18 Injection safely and effectively. See full prescribing information for Fludeoxyglucose F18 Injection. Fludeoxyglucose F18 InjectionInitial U.S. Approval: 2005 | Fludeoxyglucose [The University of Texas MD Anderson Cancer Center] | BioPortfolio

13:30 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

Multiple-dose vial containing:

or

Hypersensitivity reactions with pruritus, edema and rash have been reported in the post-marketing setting. Have emergency resuscitation equipment and personnel immediately available.

Manufactured and Distributed by:

The University of Texas MD Anderson Cancer Center

Cyclotron Radiochemistry Facility

1881 East Road

Houston, TX  77054

FDG Citrate Formulation

FDG Phosphate Formulation

Fludeoxyglucose F 18 Injection is supplied in a multi-dose, 30 mL glass vial containing:

or

The total volume and total radioactivity per vial are variable.  The contents of each vial are sterile, pyrogen-free and preservative free.  Each vial is enclosed in a shielding container of appropriate thickness.

Store the Fludeoxyglucose F 18 Injection vial upright in a shielded container at 10 - 25°C (68 - 77°F), excursions permitted to 15 - 30°C (59 - 86°F) [See USP Controlled Room Temperature].

Receipt, transfer, handling, possession, or use of this product is subject to the radioactive material regulations and licensing requirements of the U.S. Nuclear Regulatory Commission, Agreement States or Licensing States as appropriate.

Fludeoxyglucose F 18 Injection is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging.  The active ingredient 2-deoxy-2-[F]fluoro-D-glucose has the molecular formula of CH FO with a molecular weight of 181.26, and has the following chemical structure:

Fludeoxyglucose F 18 Injection is provided as a ready to use sterile, pyrogen free, clear, colorless solution. Each mL contains between 0.740 to 11.1 GBq (20.0 - 300 mCi) of 2-deoxy-2-[F]fluoro-D-glucose at the EOS, 4.5 mg of sodium chloride in citrate buffer or 0.740 to 5.55 GBq (20.0 – 150 mCi) of 2-deoxy-2-[F]fluoro-D-glucose at the EOS, 4.5 mg of sodium chloride in phosphate buffer. The pH of the solution is between 4.5 and 7.5. The solution is packaged in a multiple-dose glass vial and does not contain any preservative.

Fluorine F 18 has a physical half-life of 109.7 minutes and decays to Oxygen O 18 (stable) by positron decay. The principal photons useful for imaging are the dual 511 keV “annihilation” gamma photons that are produced and emitted simultaneously in opposite directions when the positron interacts with an electron (Table 2).

Produced by positron annihilation

From: Kocher, D.C. Radioactive Decay Tables DOE/TIC-I 1026, 89 (1981)

The specific gamma ray constant (point source air kerma coefficient) for fluorine F 18 is 5.7 R/hr/mCi (1.35 x 10 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) for the 511keV photons is 4 mm lead (Pb). The range of attenuation coefficients for this radionuclide as a function of lead shield thickness is shown in Table 3. For example, the interposition of an 8 mm thickness of Pb, with a coefficient of attenuation of 0.25, will decrease the external radiation by 75%.

For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 4.

Calibration Time

Manufacturer

The University of Texas MD Anderson Cancer Center

Active Ingredients

Source

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