the feinstein institutes for medical research - Medication Listings

11.1 Chemical Characteristics Ammonia N 13 Injection is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient, [ 13 N] ammonia, has the molecular formula of 13 NH 3 with a molecular weight of 16.02, and has the following chemical structure: Ammonia N 13 Injection is provided as a ready to use sterile, pyrogen-free, clear, and colorless solution. Each mL of the solution contains between 0.138 GBq to 1.387 GBq (3.75 mCi to 37.5 mCi) of [ 13 N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% aqueous sodium chloride. The pH of the solution is between 4.5 to 7.5. The recommended dose of radioactivity (10-20 mCi) is associated with a theoretical mass dose of 0.05-0.1 picomoles (8.47-16.94 picograms) of ammonia. NH3 Structure 11.2 Physical Characteristics Nitrogen N 13 decays by emitting positron to Carbon C 13 (stable) and has a physical half-life of 9.96 minutes. The principal photons useful for imaging are the dual 511 keV gamma photons that are produced and emitted simultaneously in opposite direction when the positron interacts with an electron (Table 2). Table 2. Principal Radiation Emission Data for Nitrogen 13 Radiation/Emission % Per Disintegration Energy Positron(β+) 100 1190 keV (Max.) Gamma(±)* 200 511 keV *Produced by positron annihilation The specific gamma ray constant (point source air kerma coefficient) for nitrogen N 13 is 5.9 R/hr/mCi (1.39 x 10 -6 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) of lead (Pb) for 511 keV photons is 4 mm. Selected coefficients of attenuation are listed in Table 3 as a function of lead shield thickness. For example, the use of 39 mm thickness of lead will attenuate the external radiation by a factor of about 1000. Table 3. Radiation Attenuation of 511 keV Photons by lead (Pb) shielding Shield Thickness (Pb) mm Coefficient of Attenuation 4 0.5 8 0.25 13 0.1 26 0.01 39 0.001 52 0.0001 Table 4 lists fractions 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 Nitrogen N 13 Minutes Fraction Remaining 0* 1.000 5 0.706 10 0.499 15 0.352 20 0.249 25 0.176 30 0.124 *Calibration time 11.1 Chemical Characteristics Ammonia N 13 Injection is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient, [ 13 N] ammonia, has the molecular formula of 13 NH 3 with a molecular weight of 16.02, and has the following chemical structure: Ammonia N 13 Injection is provided as a ready to use sterile, pyrogen-free, clear, and colorless solution. Each mL of the solution contains between 0.138 GBq to 1.387 GBq (3.75 mCi to 37.5 mCi) of [ 13 N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% aqueous sodium chloride. The pH of the solution is between 4.5 to 7.5. The recommended dose of radioactivity (10-20 mCi) is associated with a theoretical mass dose of 0.05-0.1 picomoles (8.47-16.94 picograms) of ammonia. NH3 Structure 11.2 Physical Characteristics Nitrogen N 13 decays by emitting positron to Carbon C 13 (stable) and has a physical half-life of 9.96 minutes. The principal photons useful for imaging are the dual 511 keV gamma photons that are produced and emitted simultaneously in opposite direction when the positron interacts with an electron (Table 2). Table 2. Principal Radiation Emission Data for Nitrogen 13 Radiation/Emission % Per Disintegration Energy Positron(β+) 100 1190 keV (Max.) Gamma(±)* 200 511 keV *Produced by positron annihilation The specific gamma ray constant (point source air kerma coefficient) for nitrogen N 13 is 5.9 R/hr/mCi (1.39 x 10 -6 Gy/hr/kBq) at 1 cm. The half-value layer (HVL) of lead (Pb) for 511 keV photons is 4 mm. Selected coefficients of attenuation are listed in Table 3 as a function of lead shield thickness. For example, the use of 39 mm thickness of lead will attenuate the external radiation by a factor of about 1000. Table 3. Radiation Attenuation of 511 keV Photons by lead (Pb) shielding Shield Thickness (Pb) mm Coefficient of Attenuation 4 0.5 8 0.25 13 0.1 26 0.01 39 0.001 52 0.0001 Table 4 lists fractions 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 Nitrogen N 13 Minutes Fraction Remaining 0* 1.000 5 0.706 10 0.499 15 0.352 20 0.249 25 0.176 30 0.124 *Calibration time

11.1 Chemical Characteristics Fluorodopa F 18 Injection is a radioactive diagnostic agent used in PET imaging. The active ingredient 6-[ 18 F] Fluoro-L-3, 4-dihydroxyphenylalanine has the molecular formula of C 9 H 10 FNO 4 with a molecular weight of 214.18, and has the following chemical structure: Fluorodopa F 18 Injection is a sterile, pyrogen-free, clear, colorless solution. Each mL contains between 37 MBq/mL to 1,480 MBq/mL (1 mCi/mL to 40 mCi/mL) of no-carrier added Fluorodopa F 18 (6-[ 18 F] Fluoro-L-3, 4-dihydroxyphenylalanine) at the end of synthesis (EOS). There is 40.88 mg Na-EDTA, 140 mg ascorbic acid, and 663 mg ethanol in 28 mL ±1 mL sodium phosphate buffer. The pH of the solution is between 3 and 5. FDOPA Structure 11.2 Physical Characteristics Fluorine F 18 is a cyclotron produced radionuclide that decays by positron emission to Oxygen O 18 (stable) and has a physical half-life of 109.7 minutes. The principal photons useful for imaging are the dual 511 keV gamma photons, which are produced and emitted simultaneously in opposite direction following positron-electron annihilation (Table 2). Table 2. Principal Radiation Emission Data for Fluoride F 18 Radiation/Emission % Per Disintegration Mean Energy Positron(+) 96.73 249.8 keV Gamma(±) * 193.46 511.0 keV * Produced by positron annihilation 11.3 External Radiation The point source air-kerma coefficient for F 18 is 3.75 × 10 -17 Gy m 2 / (Bq s). The half-value layer (HVL) for the 511 keV photons is 5 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 a 9 mm thickness of Pb, 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) shielding Shield thickness (Pb) mm Coefficient of Attenuation 0 0.00 5 0.50 9 0.25 15 0.10 29 0.01 39 0.001 52 0.0001 For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 4. Table 4. Physical Decay Chart for Fluorine F 18 Time Since Calibration Fraction Remaining 0 * 1.000 15 min 0.909 30 min 0.826 60 min 0.683 110 min 0.500 220 min 0.250 440 min 0.060 12 hours 0.011 24 hours 0.0001 * Calibration time 11.1 Chemical Characteristics Fluorodopa F 18 Injection is a radioactive diagnostic agent used in PET imaging. The active ingredient 6-[ 18 F] Fluoro-L-3, 4-dihydroxyphenylalanine has the molecular formula of C 9 H 10 FNO 4 with a molecular weight of 214.18, and has the following chemical structure: Fluorodopa F 18 Injection is a sterile, pyrogen-free, clear, colorless solution. Each mL contains between 37 MBq/mL to 1,480 MBq/mL (1 mCi/mL to 40 mCi/mL) of no-carrier added Fluorodopa F 18 (6-[ 18 F] Fluoro-L-3, 4-dihydroxyphenylalanine) at the end of synthesis (EOS). There is 40.88 mg Na-EDTA, 140 mg ascorbic acid, and 663 mg ethanol in 28 mL ±1 mL sodium phosphate buffer. The pH of the solution is between 3 and 5. FDOPA Structure 11.2 Physical Characteristics Fluorine F 18 is a cyclotron produced radionuclide that decays by positron emission to Oxygen O 18 (stable) and has a physical half-life of 109.7 minutes. The principal photons useful for imaging are the dual 511 keV gamma photons, which are produced and emitted simultaneously in opposite direction following positron-electron annihilation (Table 2). Table 2. Principal Radiation Emission Data for Fluoride F 18 Radiation/Emission % Per Disintegration Mean Energy Positron(+) 96.73 249.8 keV Gamma(±) * 193.46 511.0 keV * Produced by positron annihilation 11.3 External Radiation The point source air-kerma coefficient for F 18 is 3.75 × 10 -17 Gy m 2 / (Bq s). The half-value layer (HVL) for the 511 keV photons is 5 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 a 9 mm thickness of Pb, 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) shielding Shield thickness (Pb) mm Coefficient of Attenuation 0 0.00 5 0.50 9 0.25 15 0.10 29 0.01 39 0.001 52 0.0001 For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 4. Table 4. Physical Decay Chart for Fluorine F 18 Time Since Calibration Fraction Remaining 0 * 1.000 15 min 0.909 30 min 0.826 60 min 0.683 110 min 0.500 220 min 0.250 440 min 0.060 12 hours 0.011 24 hours 0.0001 * Calibration time

11.1 Chemical Characteristics Fluorodopa F 18 Injection is a radioactive diagnostic agent used in PET imaging. The active ingredient 6-[ 18 F] Fluoro-L-3, 4-dihydroxyphenylalanine has the molecular formula of C 9 H 10 FNO 4 with a molecular weight of 214.18, and has the following chemical structure: Fluorodopa F 18 Injection is a sterile, pyrogen-free, clear, colorless solution. Each mL contains between 15.5 MBq/mL to 308.2 MBq/mL (0.42 mCi/mL to 8.33 mCi/mL) of carrier added Fluorodopa F 18 (6-[ 18 F] Fluoro-L-3, 4-dihydroxyphenylalanine) at the end of synthesis (EOS); and does not contain any preservative. There is 12.72 mg acetic acid and 108 mg sodium chloride in 12 mL ±1mL sterile water for injection. The pH of the solution is between 3 and 5. FDOPA Structure 11.2 Physical Characteristics Fluorine F 18 is a cyclotron produced radionuclide that decays by positron emission to Oxygen O 18 (stable) and has a physical half-life of 109.7 minutes. The principal photons useful for imaging are the dual 511 keV gamma photons, which are produced and emitted simultaneously in opposite direction following positron-electron annihilation (Table 2). Table 2. Principal Radiation Emission Data for Fluoride F 18 Radiation/Emission % Per Disintegration Mean Energy Positron(β+) 96.73 249.8 keV Gamma(±) * 193.46 511.0 keV * Produced by positron annihilation 11.3 External Radiation The point source air-kerma coefficient for F 18 is 3.75 × 10 -17 Gy m 2 / (Bq s). The half-value layer (HVL) for the 511 keV photons is 5 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 a 9 mm thickness of Pb, 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) shielding Shield thickness (Pb) mm Coefficient of Attenuation 0 0.00 5 0.50 9 0.25 15 0.10 29 0.01 39 0.001 52 0.0001 For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 4. Table 4. Physical Decay Chart for Fluorine F 18 Time Since Calibration Fraction Remaining 0 * 1.000 15 min 0.909 30 min 0.826 60 min 0.683 110 min 0.500 220 min 0.250 440 min 0.060 12 hours 0.011 24 hours 0.0001 * Calibration time 11.1 Chemical Characteristics Fluorodopa F 18 Injection is a radioactive diagnostic agent used in PET imaging. The active ingredient 6-[ 18 F] Fluoro-L-3, 4-dihydroxyphenylalanine has the molecular formula of C 9 H 10 FNO 4 with a molecular weight of 214.18, and has the following chemical structure: Fluorodopa F 18 Injection is a sterile, pyrogen-free, clear, colorless solution. Each mL contains between 15.5 MBq/mL to 308.2 MBq/mL (0.42 mCi/mL to 8.33 mCi/mL) of carrier added Fluorodopa F 18 (6-[ 18 F] Fluoro-L-3, 4-dihydroxyphenylalanine) at the end of synthesis (EOS); and does not contain any preservative. There is 12.72 mg acetic acid and 108 mg sodium chloride in 12 mL ±1mL sterile water for injection. The pH of the solution is between 3 and 5. FDOPA Structure 11.2 Physical Characteristics Fluorine F 18 is a cyclotron produced radionuclide that decays by positron emission to Oxygen O 18 (stable) and has a physical half-life of 109.7 minutes. The principal photons useful for imaging are the dual 511 keV gamma photons, which are produced and emitted simultaneously in opposite direction following positron-electron annihilation (Table 2). Table 2. Principal Radiation Emission Data for Fluoride F 18 Radiation/Emission % Per Disintegration Mean Energy Positron(β+) 96.73 249.8 keV Gamma(±) * 193.46 511.0 keV * Produced by positron annihilation 11.3 External Radiation The point source air-kerma coefficient for F 18 is 3.75 × 10 -17 Gy m 2 / (Bq s). The half-value layer (HVL) for the 511 keV photons is 5 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 a 9 mm thickness of Pb, 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) shielding Shield thickness (Pb) mm Coefficient of Attenuation 0 0.00 5 0.50 9 0.25 15 0.10 29 0.01 39 0.001 52 0.0001 For use in correcting for physical decay of this radionuclide, the fractions remaining at selected intervals after calibration are shown in Table 4. Table 4. Physical Decay Chart for Fluorine F 18 Time Since Calibration Fraction Remaining 0 * 1.000 15 min 0.909 30 min 0.826 60 min 0.683 110 min 0.500 220 min 0.250 440 min 0.060 12 hours 0.011 24 hours 0.0001 * Calibration time

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[ 18 F] with a molecular weight of 40.99, and has the following chemical structure: Na + 18 F - 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 740 MBq to 22,200 MBq (20 mCi to 600 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 25 mL multiple-dose glass vials with variable total volume and total radioactivity in each vial. 11.2 Physical Characteristics Fluorine 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 18 O-oxygen. Table 2. Principal Emission Data for Fluoride F 18 Radiation/Emission % per Disintegration Mean Energy Positron (β+) 96.73 249.8 keV Gamma (±)* 193.46 511.0 keV *Produced by positron annihilation [3] Kocher, D.C. Radioactive Decay Data Tables DOE/TIC-11026, 69, 1981. 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). 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 8.3 mm thickness of Pb 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) 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 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 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 *Calibration time 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[ 18 F] with a molecular weight of 40.99, and has the following chemical structure: Na + 18 F - 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 740 MBq to 22,200 MBq (20 mCi to 600 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 25 mL multiple-dose glass vials with variable total volume and total radioactivity in each vial. 11.2 Physical Characteristics Fluorine 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 18 O-oxygen. Table 2. Principal Emission Data for Fluoride F 18 Radiation/Emission % per Disintegration Mean Energy Positron (β+) 96.73 249.8 keV Gamma (±)* 193.46 511.0 keV *Produced by positron annihilation [3] Kocher, D.C. Radioactive Decay Data Tables DOE/TIC-11026, 69, 1981. 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). 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 8.3 mm thickness of Pb 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) 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 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 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 *Calibration time