locametz - Medication Listings

Browse 2 medications by locametz. Open a product record to review strengths, dosage forms, label-backed details, and related navigation.

LOCAMETZ KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE
NOVARTIS PHARMACEUTICALS CORPORATION FDA Rx Only

11.1 Chemical Characteristics LOCAMETZ (kit for the preparation of gallium Ga 68 gozetotide injection) is a sterile, radioactive diagnostic agent for intravenous administration after radiolabeling. Each vial contains 25 micrograms of gozetotide, 1 mg gentisic acid, 78 mg of sodium acetate trihydrate, and 40 mg sodium chloride. Gozetotide is also known as PSMA-11. After reconstitution and radiolabeling of LOCAMETZ, the vial contains gallium Ga 68 gozetotide injection at a radioactivity of up to 2,590 MBq (70 mCi) in up to 10 mL at calibration date and time. The vial also contains hydrochloric acid derived from the gallium-68 chloride solution. Gallium Ga 68 gozetotide injection has a pH between 3.2 to 6.5. Gallium Ga 68 gozetotide is a urea based peptidomimetic that has a covalently bound chelator (HBED-CC). The peptide has amino acid sequence OH-Glu-CO-Lys(Ahx-CC-HBED)-OH. Gallium Ga 68 gozetotide has a molecular weight of 1011.91 g/mol. The chemical structure is shown in Figure 3. Figure 3. Chemical Structure of Gallium Ga 68 Gozetotide 11.2 Physical Characteristics Gallium-68 decays with a half-life of 68 minutes to stable zinc-68. Table 4 and Table 5 display the principle radiation emission data, and physical decay of gallium-68. Table 4. Principal Radiation Emission Data (> 1%) for Gallium-68 Radiation/Emission % Disintegration Mean energy (MeV) beta+ 88% 0.8360 beta+ 1.1% 0.3526 Gamma 178% 0.5110 Gamma 3% 1.0770 X-ray 2.8% 0.0086 X-ray 1.4% 0.0086 Table 5. Physical Decay Chart for Gallium-68 Minutes Fraction remaining 0 1 15 0.858 30 0.736 60 0.541 90 0.398 120 0.293 180 0.158 240 0.086 360 0.025 11.3 Radiation Attenuation Table 6 displays the radiation attenuation by lead shielding of gallium-68. Table 6. Radiation Attenuation of 511 keV Photons by Lead (Pb) Shielding Shield thickness (Pb) mm Coefficient of attenuation 6 0.5 12 0.25 17 0.1 34 0.01 51 0.001 Figure 3. Chemical Structure of Gallium Ga 68 Gozetotide

LOCAMETZ KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE
ADVANCED ACCELERATOR APPLICATIONS USA, INC FDA Rx Only

11.1 Chemical Characteristics LOCAMETZ (kit for the preparation of gallium Ga 68 gozetotide injection) is a sterile, radioactive diagnostic agent for intravenous administration after radiolabeling. Each vial contains 25 micrograms of gozetotide, 1 mg gentisic acid, 78 mg of sodium acetate trihydrate, and 40 mg sodium chloride. Gozetotide is also known as PSMA-11. After reconstitution and radiolabeling of LOCAMETZ, the vial contains gallium Ga 68 gozetotide injection at a radioactivity of up to 2,590 MBq (70 mCi) in up to 10 mL at calibration date and time. The vial also contains hydrochloric acid derived from the gallium-68 chloride solution. Gallium Ga 68 gozetotide injection has a pH between 3.2 to 6.5. Gallium Ga 68 gozetotide is a urea based peptidomimetic that has a covalently bound chelator (HBED-CC). The peptide has amino acid sequence OH-Glu-CO-Lys(Ahx-CC-HBED)-OH. Gallium Ga 68 gozetotide has a molecular weight of 1011.91 g/mol. The chemical structure is shown in Figure 3. Figure 3. Chemical Structure of Gallium Ga 68 Gozetotide 11.2 Physical Characteristics Gallium-68 decays with a half-life of 68 minutes to stable zinc-68. Table 4 and Table 5 display the principle radiation emission data, and physical decay of gallium-68. Table 4. Principal Radiation Emission Data (> 1%) for Gallium-68 Radiation/Emission % Disintegration Mean energy (MeV) beta+ 88% 0.8360 beta+ 1.1% 0.3526 Gamma 178% 0.5110 Gamma 3% 1.0770 X-ray 2.8% 0.0086 X-ray 1.4% 0.0086 Table 5. Physical Decay Chart for Gallium-68 Minutes Fraction remaining 0 1 15 0.858 30 0.736 60 0.541 90 0.398 120 0.293 180 0.158 240 0.086 360 0.025 11.3 Radiation Attenuation Table 6 displays the radiation attenuation by lead shielding of gallium-68. Table 6. Radiation Attenuation of 511 keV Photons by Lead (Pb) Shielding Shield thickness (Pb) mm Coefficient of attenuation 6 0.5 12 0.25 17 0.1 34 0.01 51 0.001 Figure 4. Chemical Structure of Gozetotide

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