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These highlights do not include all the information needed to use Sodium Fluoride F 18 Injection safely and effectively. See full prescribing information for Sodium Fluoride F 18 Injection. SODIUM FLUORIDE F 18 INJECTION For Intravenous Use Initial U.S. A | Sodium Fluoride [Kreitchman PET Center] | BioPortfolio

12:49 EST 27th January 2019 | BioPortfolio

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Multiple-dose vial containing 370-7,400 MBq/mL ( 10–200 mCi/mL)at EOS reference time of no-carrier-added sodium fluoride F18 in aqueous 0.9% sodium chloride solution. Sodium Fluoride F 18 Injection is a clear, colorless, sterile, pyrogen-free and preservative-free solution for intravenous administration.

No adverse reactions have been reported for Sodium Fluoride F 18 Injection based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems. However, the completeness of these sources is not known.

Sodium Fluoride F 18 Injection is a positron emitting radiopharmaceutical, containing no-carrier-added, radioactive fluoride F18 that is used for diagnostic purposes in conjunction with PET imaging. It is administered by intravenous injection. The active ingredient, sodium fluoride F18, has the molecular formula Na[18F] with a molecular weight of 40.99, and has the following chemical structure:

NaF

Sodium Fluoride F 18 Injection is provided as a ready-to-use, isotonic, sterile, pyrogen-free, preservative-free, clear and colorless solution. Each mL of the solution contains between 370 MBq to 7,400 MBq (10 mCi to 200 mCi) sodium fluoride F18, at the EOS reference time, in 0.9% aqueous sodium chloride. The pH of the solution is between 4.5 and 8. The solution is presented in 30 mL multiple- dose glass vials with variable total volume and total radioactivity in each vial.

Fluoride F18 decays by positron (β+) emission and has a half-life of 109.7 minutes. Ninety-seven percent of the decay results in emission of a positron with a maximum energy of 633 keV and 3% of the decay results in electron capture with subsequent emission of characteristic X-rays of oxygen. The principal photons useful for diagnostic imaging are the 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron (Table 2). Fluorine F18 atom decays to stable O-oxygen.

The specific gamma ray constant (point source air kerma coefficient) for fluoride F18 is 5.7 R/hr/mCi (1.35 x 10 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) for the 511 keV photons is 4 mm lead (Pb). A range of values for the attenuation of radiation results from the interposition of various thickness of Pb. The range of attenuation coefficients for this radionuclide 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%.

Table 4 lists the fraction of radioactivity remaining at selected time intervals from the calibration time. This information may be used to correct for physical decay of the radionuclide.

Table 2: Principal Emission Data for Fluoride F18
Radiation/Emission % per Disintegration Mean Energy
Positron (β+) 96.73 249.8 keV
Gamma (±)Produced by positron annihilation
[3] Kocher, D.C. Radioactive Decay Data Tables DOE/TIC-11026, 69, 1981.
193.46 511.0 keV
Table 3:Radiation Attenuation of 511 keV Photons by Lead (Pb) Shielding
Shield Thickness (Pb) mm Coefficient of Attenuation
0 0.00
4 0.50
8 0.25
13 0.10
26 0.01
39 0.001
52 0.0001
Table 4: Physical Decay Chart for Fluoride F18
Time Since Calibration Fraction Remaining
0Calibration time 1.00
15 minutes 0.909
30 minutes 0.826
60 minutes 0.683
110 minutes 0.500
220 minutes 0.250
440 minutes 0.060
12 hours 0.011
24 hours 0.0001

Sodium Fluoride F 18 Injection is supplied in a multiple-dose Type I glass vial with (elastomeric) stopper and aluminum crimp seal containing between 370-7,400 MBq/mL (10 to 200 mCi/mL) of no-carrier-added sodium fluoride F18, at the EOS reference time, in aqueous 0.9% sodium chloride solution. The total volume and total radioactivity per vial are variable. Each vial is enclosed in a shielding container of appropriate thickness.

The product is available in a 30 mL vial configuration with a variable fill volume. The NDC number is: 62702-500-30 (30 mL)

Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F). Use the solution within 8 hours of the EOS reference time.

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.

Manufactured by: Kreitchman PET Center, 722 W 171st St., New York, NY 10032

Manufacturer

Kreitchman PET Center

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