Presentation: Kits containing 1 freeze-dried vial containing the peptide. The product is sterile, apyrogenic, and under nitrogen atmosphere. Contains a Solution Kit for labeling with the 68Ga with:7 solution vial for injectable use, 2 empty vials and 1 vial for generator’s cleansing.
Indications: Localization of tumors that express somatostatin receptors, especially the neuroendocrine ones.
Storage: Peptides box: -18 °C.
Solutions box: 2 – 8 °C.
Postlabeling Stability: 2 hours in room temperature (15 °C – 30 °C).
Product’s expiry date: 12 months.
Number of bottles per kit: 1 + 10
Sale endorsed by RDC N. 70 DATED DECEMBER 22ND 2014 RESOLUTION.
Contraindications: hypersensitivity to edotreotide or any of the excipients.
Warnings and precautions: Category of risk during pregnancy: C. during pregnancy or lactation, use this radiopharmaceutical only in case of extreme need, when the risks of the fetus or newborn exposition to radiation are justified by the importance of the diagnosis. During lactation, the breastfeeding must be interrupted, being reestablished when the level of radiation in the milk does not result in a dose of radiation for a child higher than 1 mSv. In case of inevitable administration of the radiopharmaceutical during lactation, the nursing must be interrupted for at least 24 hours after the injection, and the milk produced during this period must be discarded. Avoid close contact between mother and the baby during 8 hours after the administration of the radiopharmaceutical.
Prescribe amount and usage: Via of administration: intravenous. The recommended activity for diagnosing neuroendocrine tumors in adult patients with 70 kg is from 100 to 200 MBq (2.7 to 5.4 mCi). The administrated activity can vary according to the equipment, protocol and exam indication. It is recommended the administration of 0.04 mCi/kg.
The dose to be administrated to the patient must be measured by a suitable radioactivity calibration system immediately before the administration. The image quality can be adversely affected by patient’s obesity, advanced age and renal insufficiency. Perform image in positron emission tomography equipment from 40 to 60 minutes after the pharmaceutical’s administration.
The image capture time can vary according to the equipment and detector (VIRGOLINI, 2010).
Studies show efficacy and safety of the use in pediatric patients with high precision to detect positive tumors for the somatostatin type 2 receptor. When necessary, the pediatric doses must be evaluated by the nuclear physician and calculated according to the Dosage Card version 5.7.2016 of the European Association of Nuclear Medicine (EANM) paper.