![]() Then continue with the incubation step k. Follow the generator specific reconstitution procedures below. Pierce the Vial 1 septum with a sterile needle connected to a 0.2 micron sterile vented filter (not supplied) to maintain atmospheric pressure within the vial during the reconstitution process. Reaction buffer volume in mL = HCl volume in mL x HCl molarity (1.1 mL x 0.1 N = 0.11 mL of reaction buffer). Solutions for use with IRE Galli Eo generator Reaction buffer volume in mL = HCl volume in mL x HCl molarity (5 mL x 0.1 N = 0.5 mL of reaction buffer). Solutions for Generator Elution and Radiolabeling Reaction Solutions for use with Eckert & Ziegler GalliaPharm generatorĥ mL of 0.1 N sterile HCl supplied by the generator manufacturerĬalculate the volume (in mL) by multiplying the volume of HCl used for the elution of the generator in mL by its molarity: Prior to piercing vial septums, flip-off cap and swab the top of the vial closure with alcohol to disinfect the surface, and allow the stopper to dry. Use 1 mL low dead space plastic syringe to precisely measure the adequate volume of reaction buffer to be added during preparation. Radiolabeling of carrier molecules with gallium (Ga 68) chloride is very sensitive to the presence of trace metal impurities. Use non-metallic or silicone coated needles to minimize trace metal impurity levels. Prepare syringes for elution and reconstitution steps per Table 1 below.į. Set the temperature of the shielded dry bath to 95☌ (203☏), and wait for the temperature to reach the set point and stabilize.Į. Ge 68 breakthrough and other gamma emitting radionuclides should be ≤ 0.001%.ĭ. Test periodically (weekly) the Ga 68 chloride eluate for Ge 68 breakthrough by suitable method. Use suitable shielding to reduce radiation exposure.Ĭ. Prepare Ga 68 dotatate for intravenous injection according to the following aseptic procedure:Ī. Ancillary supplies needed (not supplied in kit): 1 mL sterile plastic syringe, 5 mL sterile plastic syringe, non-metallic or silicone coated sterile needles, 0.2 micron sterile vented filter.Vial 2 (buffer vial) contains: 60 mg formic acid 56.5 mg sodium hydroxide and water for injection.Īncillary supplies (not included in the kit):.Vial 1 (reaction vial with lyophilized powder) contains: 40 mcg dotatate, 5 mcg 1,10-phenanthroline 6 mcg gentisic acid 20 mg mannitol.The Ge 68/Ga 68 generators are not supplied with the Netspot kit. The Netspot kit is supplied as 2 vials which allows for direct preparation of Ga 68 dotatate injection with the eluate from one of the following generators (see below for specific instructions for use with each generator): Ensure that the injected radioactivity is within ± 10% of the recommended dose. Verify the injected radioactivity by measuring the radioactivity of the vial containing the Ga 68 dotatate injection with a dose calibrator before administration to the patient. IRE ELiT Galli Eo Germanium 68/Gallium 68 (Ge 68/Ga 68) generatorĪfter reconstitution with Ga 68 chloride eluate and buffer, administer Ga 68 dotatate by intravenous injection (bolus).Eckert & Ziegler GalliaPharm Germanium 68/Gallium 68 (Ge 68/Ga 68) generator.Netspot may be radiolabeled with Ga 68 chloride eluate from the following generators: In adults and pediatric patients, the recommended amount of radioactivity to be administered for PET imaging is 2 MBq/kg (0.054 mCi/kg) of body weight up to 200 MBq (5.4 mCi). Recommended Dosage and Administration Instructions Drink and void frequently during the first hours following administration to reduce radiation exposure. Instruct patients to drink a sufficient amount of water to ensure adequate hydration prior to administration of Ga 68 dotatate. Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides. Use waterproof gloves, effective radiation shielding and appropriate safety measures when preparing and handling Ga 68 dotatate injection. DOSAGE AND ADMINISTRATION Radiation SafetyĪfter reconstitution and radiolabeling, handle the Ga 68 dotatate injection with appropriate safety measures to minimize radiation exposure. Netspot, after radiolabeling with Ga 68, is indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.
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