Use suitable shielding to reduce radiation exposure.Ĭ. Prepare Ga 68 dotatate for intravenous injection according to the following aseptic procedure (FigureĪ.
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Of Ge 68 potentially present in generator eluate. The accessory cartridge reduces the amount Accessory cartridge contains: 660 mg porous silica.Has been established only when using a Ga 68 chloride solution eluted from the GalliaPharm generator. The safety and efficacy of the Ga 68 dotatate injection drug product prepared from the Ga 68 dotatate kit GalliaPharm Ge 68/Ga 68 generator (“GalliaPharm generator”) is not supplied with the Ga 68 dotatate kit. Ziegler GalliaPharm Germanium 68/Gallium 68 (Ge 68/Ga 68) generator. The Ga 68 dotatate kit is supplied as 2 vials and an accessory cartridge which allows for direct preparation of Ga 68 dotatate injection with the eluate from an Eckert & Įnsure that the injected radioactivity is within ☑0% of the recommended dose. Verify the injected radioactivity by measuring the radioactivity of the vial containing the Ga 68ĭotatate injection with a dose calibrator before administration to the patient. Imaging is 2 MBq/kg of body weight (0.054 mCi/kg) up to 200 MBq (5.4 mCi).Īfter reconstitution with Ga 68 chloride eluate from an Eckert & Ziegler GalliaPharm GermaniumĦ8/Gallium 68 (Ge 68/Ga 68) generator and buffer, administer Ga 68ĭotatate by intravenous injection (bolus). In adults and pediatric patients, the recommended amount of radioactivity to be administered for PET Drink and void frequently during the first hours followingĪdministration to reduce radiation exposure.ģ.2 Recommended Dosage and Administration Instructions Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior toĪdministration of Ga 68 dotatate.
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Specific training and experience in the safe use and handling of radionuclides, and whose experienceĪnd training have been approved by the appropriate governmental agency authorized to license the use Radiopharmaceuticals should be used by or under the control of physicians who are qualified by Gloves, effective radiation shielding and appropriate safety measures when preparing and handling DOSAGE AND ADMINISTRATIONĪfter reconstitution and radiolabeling, handle the Ga 68 dotatate injection with appropriate safety (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and Ga 68 dotatate, after radiolabeling with Ga 68, is indicated for use with positron emission tomography Table 3: Physical Decay Chart for Gallium Ga 68 Table 2: Radiation Attenuation of 511 keV Photons by Lead (Pb) Shielding Table 1: Principal Radiation Emission Data (>1%) Radiation attenuation by lead shielding, and physical decay of Ga 68. Table 1, Table 2, and Table 3 display the principle radiation emission data, The prepared Ga 68ĭotatate injection for intravenous use, is a sterile, pyrogen free, clear, colorless, buffered solution, withĪ pH -between 3.2 - 3.8.
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