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).
#Netspot scan generator
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.
#Netspot scan license
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 Safety Drug HandlingĪfter 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. Table 6 : Physical Decay Chart for Gallium Ga 68 Minutes Table 5 : Radiation Attenuation of 511 keV Photons by Lead (Pb) Shielding Shield Thickness (Pb) mm Table 4 : Principal Radiation Emission Data (>1%) Radiation /Emission Table 4, Table 5, and Table 6 display the principle radiation emission data, radiation attenuation by lead shielding, and physical decay of Ga 68. The prepared Ga 68 dotatate injection for intravenous use, is a sterile, pyrogen free, clear, colorless, buffered solution, with a pH -between 3.2 -3.8. Accessory cartridge contains: 660 mg porous silica.Īfter reconstitution and radiolabeling,, Ga 68 dotatate injection also contains hydrochloric acid as an excipient derived from the generator eluate.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.NETSPOT is a Kit with the following components: (D)-Phenylalanyl-(L)Cysteinyl(L)-Tyrosyl-(D)-Tryptophanyl-(L)-Lysyl-(L)-Threoninyl-(L)-Cysteinyl-(L)- Threonine-cyclic(27)disulfide
įigure 2 : Chemical Structure of dotatate Dotatate has a molecular weight of 1435.6 Daltons and its chemical structure is shown in Figure 2. The peptide has the amino acid sequence: H-D- Phe-Cys- Tyr-D- Trp-Lys-ThrCys- Thr-OH, and contains one disulfide bond. NETSPOT is supplied as a sterile, single-dose kit for preparation of Ga 68 dotatate injection for intravenous use.ĭotatate, also known as DOTA-0-Tyr3-Octreotate, is a cyclic 8 amino acid peptide with a covalently bound chelator (dota). You may report side effects to FDA at 1-80. For more information, ask your doctor or pharmacist.Ĭall your doctor for medical advice about side effects. These are not all the possible side effects of Netspot. Tell the doctor if you have any side effect that bothers you or that does not go away. The most common side effects of Netspot include: Get medical help right away, if you have any of the symptoms listed above.
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