![]() #Netspot gallium 68 dotatate generator#Elute the generator directly into the Vial 1 through the cartridge and the needle 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 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 bottom of the cartridge with a sterile needle. Connect the top of the cartridge to the male luer of the outlet line of the GalliaPharm generator. Reaction buffer volume in mL = HCl volume in mL x HCl molarity (for the GalliaPharm generator eluate, 5 mL x 0.1 N = 0.5 mL of reaction buffer). Using a 1 mL sterile syringe, withdraw the required volume of the reaction buffer from Vial 2.Ĭalculate the volume (in mL) by multiplying the volume of HCl used for the elution of the generator in mL by its molarity: Remove the cap from the Vial 2 (buffer vial), swab the top of the vial with alcohol to disinfect the surface, and allow the stopper to dry. 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. Remove the cap from Vial 1 (reaction vial), swab the top of the vial with alcohol to disinfect the surface, and allow the stopper to dry.į. The Ga 68 chloride is sterile as eluted from the GalliaPharm generator.Į. Other gamma emitting radionuclides should be ≤ 0.001%. Test periodically (weekly) the Ga 68 chloride eluate for Ge 68 breakthrough by suitable method. Use 0.1N sterile HCl supplied by the generator manufacturer. Prepare a syringe containing 5 mL of 0.1 N sterile HCl, to be used for elution of the GalliaPharm Set the temperature of the shielded dry bath to 203 ☏ (95 ☌), and wait for the temperature to reach the set point and stabilize.ĭ. Use suitable shielding to reduce radiation exposure.Ĭ. Prepare Ga 68 dotatate for intravenous injection according to the following aseptic procedure (see above diagram):Ī. Of Ge 68 potentially present in generator eluate. The accessory cartridge reduces the amount Vial 2 (buffer vial) contains: 60 mg formic acid 56.5 mg sodium hydroxide and water for injection.Īccessory cartridge contains: 660 mg porous silica. Vial 1 (reaction vial with lyophilized powder) contains: 40 mcg dotatate, 5 mcg 1,10-phenanthroline 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 NETSPOT kit GalliaPharm Ge 68/Ga 68 generator (“GalliaPharm generator”) is not supplied with the NETSPOT kit. Ziegler GalliaPharm Germanium 68/Gallium 68 (Ge 68/Ga 68) generator. (3) ] which allows for direct preparation of Ga 68 DOTATATE injection with the eluate from an Eckert & The NETSPOT kit is supplied as 2 vials and an accessory cartridge [see Dosage Forms and Strengths Here is an example of three generators linked to an accessory cartridgeĭrug Preparation (link to entire package insert). ![]() Following an elution of 68Ga of 60 mCi, how long would you have to wait to get an additional 45 mCi?.T1/2 of 68Ge is 271 days and the T1/2 of 68Ga is 68 minutes.Via a cyclotron 68Ge is made: 68Zn(p,n) 68Ga. ![]() Currently only DOTATATE has been approved by the FDG (June 2016)
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