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Sodium Fluoride

These highlights do not include all the information needed to use Sodium Fluoride F-18 Injection, USP, safely and effectively. See full prescribing information for Sodium Fluoride F-18 Injection, USP. Sodium Fluoride F-18 Injection, USPFor Intravenous UseInitial U.S. Approval: 2011

Approved
Approval ID

96e61ba1-30ca-4844-b503-056afd247e69

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 20, 2018

Manufacturers
FDA

Cardinal Health 414, LLC

DUNS: 069410546

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Sodium Fluoride F18

PRODUCT DETAILS

NDC Product Code65857-300
Application NumberANDA203780
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateOctober 3, 2016
Generic NameSodium Fluoride F18

INGREDIENTS (1)

SODIUM FLUORIDE F-18Active
Quantity: 200 mCi in 1 mL
Code: 9L75099X6R
Classification: ACTIM

Drug Labeling Information

DESCRIPTION SECTION

LOINC: 34089-3Updated: 10/3/2016

11 DESCRIPTION

11.1 Chemical Characteristics

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

Na+18F–

Sodium Fluoride F-18 Injection, USP, 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 F-18, 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.

11.2 Physical Characteristics

Fluoride F-18 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 F-18 atom decays to stable 18O-oxygen.

Table 2. Principal Emission Data for Fluoride F-18
  • Produced by positron annihilation
    From: Kocher, D.C. Radioactive Decay Data Tables DOE/TIC-11026, 69, 1981

** Radiation/Emission**

** % Per Disintegration**

** Mean Energy**

Positron(β+)

96.73

249.8 keV

Gamma(±)*

193.46

511.0 keV

The specific gamma ray constant for fluoride F-18 is 5.7 R/hr/mCi (1.35 x 10-6 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) for the 511 keV photons is 4.1 mm lead (Pb) or 2.9 mm tungsten (W) alloy. A range of values for the attenuation of radiation results from the interposition of various thickness of Pb or Tungsten alloy. The range of attenuation coefficients for this radionuclide is shown in Table 3. For example, the interposition of an 8.3 mm thickness of Pb or 5.8 mm thickness of W alloy with a coefficient of attenuation of 0.25 will decrease the external radiation by 75%.

Table 3. Radiation Attenuation of 511 keV Photons by lead (Pb) and Tungsten (W) alloy shielding

** Shield Thickness**
(Pb) mm

** Shield Thickness**
(W) Alloy mm

** Coefficient of**
Attenuation

0

0

0.00

4

3

0.50

8

6

0.25

13

9

0.10

26

19

0.01

39

28

0.001

53

37

0.0001

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 4. Physical Decay Chart for Fluoride F-18
  • calibration time

** Time Since Calibration**

** Fraction Remaining**

0*

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

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