Quốc gia: Liên Minh Châu Âu
Ngôn ngữ: Tiếng Anh
Nguồn: EMA (European Medicines Agency)
edotreotide
Advanced Accelerator Applications
V09IX
edotreotide
Diagnostic radiopharmaceuticals
Neuroendocrine Tumors; Radionuclide Imaging
This medicinal product is for diagnostic use only.After radiolabelling with gallium (68Ga) chloride solution, the solution of gallium (68Ga) edotreotide obtained is indicated for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastro-enteropancreatic neuroendocrine tumours (GEP-NET) for localizing primary tumours and their metastases.
Revision: 15
Authorised
2016-12-08
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE USER SOMAKIT TOC 40 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION edotreotide READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure. - If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What SomaKit TOC is and what it is used for 2. What you need to know before SomaKit TOC is used 3. How SomaKit TOC is used 4. Possible side effects 5. How SomaKit TOC is stored 6. Contents of the pack and other information 1. WHAT SOMAKIT TOC IS AND WHAT IT IS USED FOR This medicine is a radiopharmaceutical for diagnostic use only. It contains the active substance edotreotide. Before it can be used, the powder in the vial is mixed with a radioactive substance called gallium ( 68 Ga) chloride to make gallium ( 68 Ga) edotreotide (this procedure is called radiolabelling). Gallium ( 68 Ga) edotreotide contains a small amount of radioactivity. After injection into a vein, it can make parts of the body visible to doctors during a medical imaging procedure called positron emission tomography (PET). This medical procedure obtains images of your organs to help locate abnormal cells or tumours, giving valuable information about your disease. The use of SomaKit TOC involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit from the procedure with the radiopharmaceutical outweighs the risk due to radiation. 31 2. WHAT YOU NEED TO KNOW BEFORE SOMAKIT TOC IS USED SOMAKIT TOC MUST NOT BE USED - if you are allergic to edotreotide or any of the other ingredients of this medicine (listed in section 6). WARNINGS AND PRECAUTIONS Talk to your nuclear medicine docto Đọc toàn bộ tài liệu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of powder contains 40 micrograms of edotreotide. The radionuclide is not part of the kit. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Kit for radiopharmaceutical preparation containing: - Powder for solution for injection: the vial contains a white lyophilised powder. - Reaction buffer: the vial contains a clear, colourless solution. For radiolabelling with gallium ( 68 Ga) chloride solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. After radiolabelling with gallium ( 68 Ga) chloride solution, the solution of gallium ( 68 Ga) edotreotide obtained is indicated for positron emission tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastro- enteropancreatic neuroendocrine tumours (GEP-NET) for localising primary tumours and their metastases. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The medicinal product should only be administered by trained healthcare professionals with technical expertise in using and handling nuclear medicine diagnostic agents and only in a designated nuclear medicine facility. Posology The recommended activity for an adult weighing 70 kg is 100 to 200 MBq, administered by direct slow intravenous injection. The activity will be adapted to patient characteristics, the type of PET camera used and acquisition mode. _Elderly _ No special dose regimen for elderly patients is required. _Renal/Hepatic impairment _ The safety and efficacy of gallium ( 68 Ga) edotreotide have not been studied in patients with renal or hepatic impairment. 3 _Paediatric population _ The safety and efficacy of gallium ( 68 Ga) edotreotide have not been established in paediatric populations, where the effective dose might be different than in adults. There is Đọc toàn bộ tài liệu