![]() ![]() PET images with Ga 68 dotatate should be interpreted visually and the uptake may need to be confirmed by histopathology or other assessments. Increased uptake might also be seen in sites of splenosis or other pathologic conditions (e.g., thyroid disease or subacute inflammation) or might occur as a normal physiologic variant (e.g., uncinate process of the pancreas). However, uptake can also be seen in a variety of other tumor types (e.g., those derived from neural crest tissue). The uptake of Ga 68 dotatate reflects the level of somatostatin receptor density in NETs. Less frequently hypersensitivity reactions included angioedema or cases with features of anaphylaxis. Reactions reversed either spontaneously or with routine symptomatic management. Hypersensitivity reactions following administration of somatostatin receptor imaging agents predominantly consisted of cutaneous reactions, such as rash and pruritus. Avoid close contact with infants and pregnant women during the first 12 hours after administration of Ga 68 dotatate. Ensure safe handling and preparation reconstitution procedures to protect patients and health care workers from unintentional radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ga 68 dotatate contributes to a patient’s overall long-term cumulative radiation exposure. 5 WARNINGS AND PRECAUTIONS 5.1 Radiation Risk IRE ELiT Galli Eo (Ge 68/Ga 68) generatorĪfter reconstitution with Ga 68 and pH adjustment with Reaction Buffer, Vial 1 contains a sterile solution of Ga 68 dotatate at a strength of up to 218 MBq/mL (5.89 mCi/mL).Eckert & Ziegler GalliaPharm Ge 68/Ga 68 generator.Gallium 68 is obtained from one of the following generators: Vial 2 (buffer vial): clear, and colorless reaction buffer solution (60 mg formic acid, 56.5 mg sodium hydroxide in approximately 1 mL volume) in a 10 mL olefin polymer vial with a yellow flip-off cap.Vial 1 (reaction vial with lyophilized powder): 40 mcg of dotatate, 5 mcg of 1,10-phenanthroline, 6 mcg gentisic acid and 20 mg D-mannitol for injection as a white lyophilized powder in a 10 mL glass vial with light-blue flip-off cap.For Injection: NETSPOT is supplied as a single-dose kit, containing two vials for preparation of Ga 68 dotatate injection: ![]()
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