Safety and efficacy of 68Ga-DOTATATE PET/CT for diagnosis, staging, and treatment management of neuroendocrine tumors. Manufactured by: Gipharma S.r.l., Strada Crescentino snc, 13040 Saluggia (Vc), ItalyÄistributed by: Advanced Accelerator Applications USA, Inc., NJ 07041 BACK TO TOP #Ga 68 netspot full#To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-88 or or FDA at 1-80 or Please see accompanying full Prescribing Information. If possible, an estimate of the radioactive dose given to the patient should be performed.In the event of a radiation overdose, the absorbed dose to the patient should be reduced where possible by increasing the elimination of the radionuclide from the body by reinforced hydration and frequent bladder voiding.Advise a lactating woman to interrupt breastfeeding and pump and discard breast milk for 12 hours after Ga 68 dotatate administration in order to minimize radiation exposure to a breastfed infant.There is no information on the presence of Ga 68 dotatate in human milk, the effect on the breastfed infant, or the effect on milk production.There are no studies with Ga 68 dotatate in pregnant women to inform any drug-associated risks however, all radiopharmaceuticals, including Ga 68 dotatate have the potential to cause fetal harm.Short-acting somatostatin analogs can be used up to 24 hours before imaging with Ga 68 dotatate.Image patients with Ga 68 dotatate PET just prior to dosing with long-acting somatostatin analogs. Non-radioactive somatostatin analogs competitively bind to the same somatostatin receptors as Ga 68 dotatate.Post Marketing Experience: Nausea, vomiting, and injection site pain and burning sensation were all reported during post approval use.No serious adverse reactions were identified. Clinical Trials Experience: The safety of Ga 68 dotatate was evaluated in three single center studies and in a survey of the scientific literature.Uptake may need to be confirmed by histopathology or other assessments.thyroid disease or subacute inflammation) or might occur as a normal physiologic variant (e.g. Increased uptake might also be seen in other pathologic conditions (e.g.However, uptake can also be seen in a variety of other tumor types (e.g. The uptake of Ga 68 dotatate reflects the level of somatostatin receptor density in NETs.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.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.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.
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