Ülke: Malta
Dil: İngilizce
Kaynak: Medicines Authority
HYNIC, D, PHE, TYR, OCTREOTIDE, TRIFLUOROACETATE
Narodowe Centrum Badan Jadrowych ul. Andrzeja Soltana 7, 05-400, Otwock,, Poland
V09IA07
HYNIC-[D-PHE1,TYR3-OCTREOTIDE] TRIFLUOROACETATE 20 µg
KIT FOR RADIOPHARMACEUTICAL PREPARATION
HYNIC-[D-PHE1,TYR3-OCTREOTIDE] TRIFLUOROACETATE 20 µg
POM
DIAGNOSTIC RADIOPHARMACEUTICALS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2022-02-09
Page 1 of 4 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TEKTROTYD 20 MICROGRAMS, KIT FOR RADIOPHARMACEUTICAL PREPARATION HYNIC-[D-Phe 1 , Tyr 3 -Octreotide] trifluoroacetate 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. WHAT IS IN THIS LEAFLET: 1. What Tektrotyd is and what it is used for 2. What you need to know before Tektrotyd is used 3. How Tektrotyd is used 4. Possible side effects 5. How Tektrotyd is stored 6. Contents of the pack and other information 1. WHAT TEKTROTYD IS AND WHAT IT IS USED FOR This medicine is a radiopharmaceutical product used to help identify (diagnose) some medical problems. In particular, it is used to make images of specific cells in the stomach, bowel and pancreas such as: • ABNORMAL TISSUE OR • TUMOURS _ _ Tektrotyd bound to radioactive isotope attaches to abnormal or tumour cells that have receptors for it (somatostatin receptors). Later, radiation-measuring device (gamma-camera) detects the radiation, and makes pictures showing where the abnormal/tumour cells are in the body. The use of Tektrotyd does involve exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation. 2. WHAT YOU NEED TO KNOW BEFORE TEKTROTYD IS USED TEKTROTYD MUST NOT BE USED - if you are allergic to the active substance of Tektrotyd _,_ or to any of the excipients of this medicine (listed in section 6) or to sodium pertechnetate ( 99m Tc) solution for injection. - if you are pregnant or believe you may be pregnant - if you are breast-feeding. Please see the section “Pre Belgenin tamamını okuyun
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tektrotyd, 20 micrograms, kit for radiopharmaceutical preparation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Vial I contains 20 micrograms of HYNIC-[D-Phe 1 ,Tyr 3 -Octreotide] trifluoroacetate 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 White or almost white lyophilisates For radiolabelling with sodium pertechnetate ( 99m Tc) solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. After radiolabelling with sodium pertechnetate ( 99m Tc) solution, the solution of 99m Tc- Tektrotyd obtained is indicated for use in adults as adjunct in the diagnosis and management of somatostatin receptor bearing neuroendocrine tumours (NET), by aiding their localization. Tumours which do not bear somatostatin receptors will not be visualised (see section 4.4, “image interpretation”). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults The suggested activity range is 370 to 740 MBq in one single intravenous injection. The activity to be administered depends on the available equipment. Elderly population (above 65 years) No dose adjustment is required for elderly. Renal impairment Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients, see section 4.4. Hepatic impairment Dosage reduction in hepatic impairment is not necessary, see section 5.2. Paediatric population There are no data on safety and efficacy of 99m Tc-Tektrotyd for the use in paediatric patients. If alternative techniques not using ionising radiation are not available, the use in children and adolescents has to be considered carefully, based upon clinical needs and assessing the risk/benefit ratio in this patient group. Because of the potential hazard of ionising radiation, 99m Tc-Tektrotyd should not be used in children under 18 years of age, unles Belgenin tamamını okuyun