Perform the elution manually or by means of a pump. Elute the generator directly into the Vial 1 according to the instructions for use of the GalliaPharm generator that are supplied by Eckert & Ziegler, in order to reconstitute the lyophilized powder with 5 mL of eluate.Connect Vial 1 directly to the outlet line of the GalliaPharm generator by pushing the needle through the rubber septum and place the vial in a lead shield container.Connect the male luer of the outlet line of the GalliaPharm generator to a sterile needle.Reconstitution with Eckert & Ziegler GalliaPharm generator Then continue with the incubation step h. Follow the generator specific reconstitution procedures below. Pierce the Vial 1 septum with a sterile needle connected to a 0.22 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).į. 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). 5 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: Solutions for Generator Elution and Radiolabeling Reaction Solutions for use with Eckert & Ziegler GalliaPharm generator 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. Prepare syringes for elution and reconstitution steps per Table 1 below. Set the temperature of the shielded dry bath to 203 ☏ (95 ☌), 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. Vial 2 (buffer vial) contains: 60 mg formic acid 56.5 mg sodium hydroxide and water for injection. 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 ☑0% 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 of body weight (0.054 mCi/kg) 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. Netspot 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. Show On This Page Indications and Usage for Netspot
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