medi-physics, inc. dba ge healthcare - Medication Listings

11.1 Chemical Characteristics Ceretec (kit for the preparation of technetium Tc 99m exametazime injection) prepares a radioactive diagnostic agent for intravenous use. Each unit consists of the following: One 10 mL vial of exametazime containing a sterile, non-pyrogenic, lyophilized mixture of 0.5 mg exametazime, 7.6 mcg stannous chloride dihydrate (minimum stannous tin 0.6 mcg; maximum total stannous and stannic tin 4 mcg per vial) and 4.5 mg sodium chloride, sealed under nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative. One vial of cobalt stabilizer containing a sterile, non-pyrogenic solution of 200 mcg cobaltous chloride 6-hydrate in 2 mL of Water for Injection. The chemical name for Exametazime is [(RR,SS)-4.8-diaza-3,6,6,9-tetramethylundecane-2, 10-dione bisoxime]. The molecular formula of exametazime is C 13 H 28 N 4 O 2 , with the following structural formula: Prior to publication of the USAN, exametazime was known as hexamethylpropylene amine oxime (HM-PAO). The name HM-PAO appears in many publications. When sterile pyrogen-free sodium pertechnetate Tc 99m in isotonic saline is added to the vial of exametazime, a Tc 99m complex of exametazime is formed. Chemical Structure 11.2 Physical Characteristics Technetium Tc 99m decays by isomeric transition with a physical half-life of 6 hours. Photons that are useful for imaging studies are listed in Table 3. Table 3: Principal Radiation Emission Data-technetium Tc 99m Radiation Mean % Disintegration Mean Energy (keV) Gamma 2 88.5 140.5 11.3 External Radiation The air-kerma-rate (exposure-rate) constant for technetium Tc 99m is 5.23 m 2 ∙pGy∙(MBq) –1 ∙s –1 [0.795 cm 2 ∙R∙(mCi) –1 ∙h –1 ]. The first half-value thickness of lead (Pb) for technetium Tc 99m is 0.25 mm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 4. For example, the use of a 3 mm thickness of Pb will decrease the external radiation exposure by a factor of approximately 1,000. Table 4: Radiation Attenuation by Lead Shielding Shield Thickness (Pb) mm Coefficient of Attenuation 0 . 25 0.5 1 10 –1 2 10 –2 3 10 –3 4 10 –4 5 10 –5 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals relative to the time of calibration are shown in Table 5. Table 5: Physical Decay Chart – Tc 99m half-life 6.03 hours Hours Fraction Remaining Hours Fraction Remaining 0 Calibration time (time of preparation) 1 7 0.447 1 0.891 8 0.399 2 0.795 9 0.355 3 0.708 10 0.317 4 0.631 11 0.282 5 0.563 12 0.252 6 0.502 24 0.063

The Ceretec kit is supplied as a pack of 5 vials for use in the preparation of a technetium Tc99m exametazime intravenous injection as a diagnostic radiopharmaceutical for use as an adjunct in the detection of altered regional cerebral perfusion and for the radiolabeling of autologous leukocytes. Each vial of Ceretec contains a pre-dispensed sterile, non-pyrogenic, lyophilized mixture of 0.5 mg exametazime [(RR,SS)-4.8-diaza-3,6,6,9-tetramethylundecane-2, 10-dione bisoxime], 7.6 µg stannous chloride dihydrate (minimum stannous tin 0.6 µg; maximum total stannous and stannic tin 4.0 µg per vial) and 4.5 mg sodium chloride, sealed under nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative. Prior to publication of the USAN, exametazime was formerly known as hexamethylpropylene amine oxime (HM-PAO). The name HM-PAO appears in many publications. The structural formula of exametazime is: When sterile pyrogen-free sodium pertechnetate Tc99m in isotonic saline is added to the vial of Ceretec, a Tc99m complex of exametazime is formed. Administration is by intravenous injection for diagnostic use. Physical Characteristics Technetium Tc99m decays by isomeric transition with a physical half-life of 6.03 hours. (1) Photons that are useful for imaging studies are listed in Table 1. Table 1. Principal Radiation Emission Data-technetium Tc99m Radiation Mean %/ Disintegration Mean Energy (keV) (1) Dillman, L.T. and Von der Lage, F.C. Radionuclide decay schemes and nuclear parameters for use in radiation-dose estimation. MIRD Phamphlet No. 10, p. 62, 1975. Gamma 2 87.87 140.5 External Radiation The specific gamma ray constant for technetium Tc99m is 206 microCoulomb kg-1/37 MBq-h, (0.8 R/millicurie-h) at 1 cm. The first half-value thickness of lead (Pb) for technetium Tc99m is 0.2 mm. A range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of a 2.7 mm thickness of Pb will decrease the external radiation exposure by a factor of 1,000. Table 2. Radiation Attenuation by Lead Shielding Shield Thickness (Pb) mm Coefficient of Attenuation 0.2 0.5 0.95 10 –1 1.8 10 –2 2.7 10 –3 3.6 10 –4 4.5 10 –5 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals relative to the time of calibration are shown in Table 3. Table 3. Physical Decay Chart: Tc99m half-life 6.03 hours Hours Fraction Remaining Hours Fraction Remaining 0 Calibration time (time of preparation) 1.000 7 0.447 1 0.891 8 0.399 2 0.795 9 0.355 3 0.708 10 0.317 4 0.631 11 0.282 5 0.563 12 0.252 6 0.502 24 0.063 Chemical Structure

11.1 Chemical Characteristics DATSCAN (ioflupane I 123 injection) is a sterile, pyrogen-free radioactive diagnostic agent for intravenous use. DATSCAN is a clear and colorless solution supplied in single-dose vials. Each milliliter contains 0.07 to 0.13 mcg ioflupane, 74 MBq (2 mCi) of iodine-123 (as ioflupane I 123) at calibration time, 5.8 mg acetic acid, 8.2 mg sodium acetate and 0.05 mL (5%) ethanol. The pH of the solution is between 4.2 and 5.2. The chemical name for ioflupane I 123 is N-ω-fluoropropyl-2β-carbomethoxy-3β-(4-[ 123 I]iodophenyl)nortropane and it has the following structural formula: Chemical Structure 11.2 Physical Characteristics Iodine-123 is a cyclotron-produced radionuclide that decays to tellurium-123 by electron capture and has a physical half-life of 13.2 hours. The photon that is useful for detection and imaging studies is listed in Table 2. Table 2 Principal Radiation Emission Data – Iodine-123 Radiation Energy Level (keV) Abundance (%) Gamma 159 83 11.3 External Radiation The specific gamma-ray constant for iodine-123 is 1.6 R/mCi-hr at 1 cm. The first half-value thickness of lead (Pb) for iodine-123 is 0.04 cm. The relative transmission of radiation emitted by the radionuclide that results from interposition of various thicknesses of Pb is shown in Table 3 (e.g., the use of 2.16 cm Pb will decrease the external radiation exposure by a factor of about 1,000). Table 3 Reduction in In-air Collision Kerma Caused by Lead Shielding Calculation based on attenuation and energy-transfer coefficients obtained from National Institute of Standards & Technology Internal Report NISTIR 5632. Shield Thickness cm of lead (Pb) Reduction in In-air Collision Kerma 0.04 0.5 0.13 10 -1 0.77 10 -2 2.16 10 -3 3.67 10 -4

GE Healthcare (Medi-Physics, Inc.) Indium DTPA In 111 is a diagnostic drug for intrathecal use. It is available as a sterile, pyrogen-free, isotonic, aqueous solution, buffered to pH 7 to 8. At calibration time, each milliliter contains 37 MBq, 1 mCi of Pentetate Indium Disodium In 111 (no-carrier-added), 20 to 50 µ g of pentetic acid, and sodium bicarbonate for pH adjustment. The drug is to be discarded after single use. Radionuclidic purity at calibration time is at least 99.88% with less than 0.06% Indium In 114m and 0.06% Zinc Zn 65. The concentration of each radionuclidic contaminant changes with time. Graph 1 shows maximum concentration of each radionuclidic impurity as a function of time. Graph 1 - Radionuclidic Impurities The chemical names are 1. Indate(2-)- 111 In -[ N,N -bis[2-[bis-(carboxymethyl)amino]ethyl]glycinato(5-)]-disodium; and 2. Disodium [ N,N -bis[2-(carboxymethyl)amino]glycinato(5-)]-indate (2-) 111 In. Molecular formula: C 14 H 18 O 10 N 3 111 In Na 2 Molecular weight: 545.29 Structural formula: PHYSICAL CHARACTERISTICS Indium 111 decays by electron capture with a physical half-life of 67.9 hours. The energies of the photons that are useful for detection and imaging studies are listed in Table 1. Table 1. Principal Radiation Emission Data Kocher, David C.,"Radioactive Decay Data Tables,"DOE/TIC-11026, 115, (1981). Radiation Mean %/Disintegration Mean Energy (keV) Gamma-2 90.2 171.3 Gamma-3 94.0 245.4 EXTERNAL RADIATION The specific gamma ray constant for Indium In 111 is 3.3 R/hr-mCi at 1 cm. The half-value thickness of lead (Pb) for Indium In 111 is 0.021 cm. To facilitate control of the radiation exposure from millicurie amounts of this radionuclide, a range of values for the relative attenuation of the radiation emitted by this radionuclide that results from interposition of various thicknesses of Pb is shown in Table 2. For example, the use of a 0.8 cm thickness of Pb will attenuate the radiation emitted by a factor of about 1,000. Table 2. Radiation Attenuation by Lead Shielding Shield Thickness (Pb) cm Coefficient of Attenuation To correct for physical decay of this radionuclide, the fractions that remain at selected time intervals after the time of calibration are shown in Table 3. 0.021 0.5 0.19 10 -1 0.49 10 -2 0.80 10 -3 1.1 10 -4 Table 3. Physical Decay Chart: Indium In 111, Half-Life 67.9 Hours Hours Fraction Remaining Hours Fraction Remaining 0 Calibration Time 1.000 84 0.424 12 0.885 96 0.375 24 0.783 108 0.332 36 0.693 120 0.294 48 0.613 132 0.260 60 0.542 144 0.230 72 0.480 168 0.180 Graph 1 Structural formula

Indium In 111 Oxyquinoline (oxine) Solution is a diagnostic radiopharmaceutical intended for radiolabeling autologous leukocytes. It is supplied as a sterile, non-pyrogenic, isotonic aqueous solution with a pH range of 6.5 to 7.5 [sodium hydroxide and hydrochloric acid may be used to adjust the pH]. Each mL of the solution contains 37 MBq, 1 mCi of indium In 111 [no carrier added, >1.85 GBq/mcg indium (>50 mCi/mcg indium)] at calibration time, 50 mcg oxyquinoline, 100 mcg polysorbate 80, and 6 mg of HEPES (N-2-hydroxyethyl-piperazine-N'-2-ethane sulfonic acid) buffer in 0.75% Sodium Chloride Solution. The drug is intended to be used as a single-dose vial and contains no bacteriostatic agent. The radionuclidic impurity limit for indium 114m is not greater than 37 kBq, 1 µCi of indium 114m per 37 MBq, 1 mCi of indium In 111 at the time of calibration. The radionuclidic composition at expiration time is not less than 99.75% of indium In 111 and not more than 0.25% of indium In 114m/114. Chemical name: Indium In 111 Oxyquinoline. The precise structure of the indium In 111 oxyquinoline complex is unknown at this time. The empirical formula is (C 9 H 6 NO) 3 In 111.

11.1 Chemical Characteristics MYOVIEW 30 mL is a kit for the preparation of technetium Tc99m tetrofosmin injection for intravenous use. Technetium Tc99m tetrofosmin is a radioactive diagnostic agent. Each multiple-dose 30 mL glass vial contains a sterile, non-pyrogenic, lyophilized powder of 1.38 mg tetrofosmin [6,9-bis(2-ethoxyethyl)-3,12-dioxa-6,9-diphosphatetradecane], 0.09 mg stannous chloride dihydrate, (minimum stannous tin 0.015 mg; total stannous and stannic tin 0.0522 mg) 1.92 mg disodium sulphosalicylate, 3 mg sodium D-gluconate, and 11 mg sodium hydrogen carbonate, and 3 mg ascorbic acid. The lyophilized powder is sealed under a nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative. The chemical formula of tetrofosmin is C 18 H 40 O 4 P 2 with the following structural formula: When sterile, pyrogen-free sodium pertechnetate Tc99m in isotonic saline is added to the vial, a Tc99m complex of tetrofosmin is formed. The radiolabeled product is a clear solution and the pH is in the range of 7.5 to 9.0. Chemical Structure 11.2 Physical Characteristics Technetium Tc99m decays by isomeric transition with a physical half-life of 6 hours. Photons that are useful for imaging studies are listed in Table 2. Table 2 Principal radiation emission data - technetium Tc99m Radiation Mean % disintegration Mean energy (keV) Gamma 2 88.5 140.5 11.3 External Radiation The air-kerma-rate (exposure-rate) constant for technetium Tc99m is 5.23 m 2 ∙pGy∙(MBq) –1 ∙s –1 [0.795 cm 2 ∙R∙(mCi) –1 ∙h –1 ]. A range of values for the relative radiation attenuation by various thicknesses of Pb shielding is shown in Table 3. For example, the use of 3 mm thick Pb will decrease the external radiation exposure by a factor of approximately 1,000. Table 3 Radiation attenuation by lead shielding Shield thickness (Pb) mm Factor of attenuation 0.25 0.5 1 10 -1 2 10 -2 3 10 -3 4 10 -4 5 10 -5 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals relative to the time of calibration are shown in Table 4. Table 4 Physical decay chart - Tc99m half-life 6 hours Hours Fraction Remaining Hours Fraction Remaining 0 Calibration time (time of preparation) 1.000 7 0.446 1 0.891 8 0.397 2 0.794 9 0.354 3 0.707 10 0.315 4 0.630 11 0.281 5 0.562 12 0.250 6 0.500 24 0.063

11.1 Chemical Characteristics MYOVIEW is a kit for the preparation of technetium Tc99m tetrofosmin injection for intravenous use. Technetium Tc99m tetrofosmin is a radioactive diagnostic agent. Each multiple-dose 10 mL glass vial contains a sterile, non-pyrogenic, lyophilized powder of 0.23 mg tetrofosmin [6,9-bis(2-ethoxyethyl)-3,12-dioxa-6,9-diphosphatetradecane], 0.03 mg stannous chloride dihydrate, (minimum stannous tin 0.015 mg; total stannous and stannic tin 0.0522 mg) 0.32 mg disodium sulphosalicylate, 1 mg sodium D-gluconate, and 1.8 mg sodium hydrogen carbonate. The lyophilized powder is sealed under a nitrogen atmosphere with a rubber closure. The product contains no antimicrobial preservative. The chemical formula of tetrofosmin is C 18 H 40 O 4 P 2 with the following structural formula: C 18 H 40 O 4 P 2 When sterile, pyrogen-free sodium pertechnetate Tc99m in isotonic saline is added to the vial, a Tc99m complex of tetrofosmin is formed. The radiolabeled product is a clear solution and the pH is in the range of 7.5 to 9.0. Chemical Structure 11.2 Physical Characteristics Technetium Tc99m decays by isomeric transition with a physical half-life of 6 hours. Photons that are useful for imaging studies are listed in Table 2. Table 2 Principal radiation emission data - technetium Tc99m Radiation Mean % disintegration Mean energy (keV) Gamma 2 88.5 140.5 11.3 External Radiation The air-kerma-rate (exposure-rate) constant for technetium Tc99m is 5.23 m 2 ∙pGy∙(MBq) −1 ∙s −1 [0.795 cm 2 ∙R∙(mCi) −1 ∙h −1 ]. A range of values for the relative radiation attenuation by various thicknesses of Pb shielding is shown in Table 3. For example, the use of 3 mm thick Pb will decrease the external radiation exposure by a factor of approximately 1,000. Table 3 Radiation attenuation by lead shielding Shield thickness (Pb) mm Factor of attenuation 0.25 0.5 1 10 -1 2 10 -2 3 10 -3 4 10 -4 5 10 -5 To correct for physical decay of this radionuclide, the fractions that remain at selected intervals relative to the time of calibration are shown in Table 4. Table 4 Physical decay chart - Tc99m half-life 6 hours Hours Fraction Remaining Hours Fraction Remaining 0 Calibration time (time of preparation) 1.000 7 0.446 1 0.891 8 0.397 2 0.794 9 0.354 3 0.707 10 0.315 4 0.630 11 0.281 5 0.562 12 0.250 6 0.500 24 0.063