Valsts: Eiropas Savienība
Valoda: angļu
Klimata pārmaiņas: EMA (European Medicines Agency)
copper (64Cu) chloride
A.C.O.M. - Advanced Center Oncology
Not yet assigned
copper (64Cu) chloride
Various diagnostic radiopharmaceuticals
Radionuclide Imaging
Cuprymina is a radiopharmaceutical precursor. It is not intended for direct use in patients. This medicinal product must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.
Revision: 8
Authorised
2012-08-23
19 B. PACKAGE LEAFLET 20 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT CUPRYMINA 925 MBQ/ML RADIOPHARMACEUTICAL PRECURSOR, SOLUTION Copper ( 64 Cu) chloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THE MEDICINE COMBINED WITH CUPRYMINA 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 Cuprymina is and what it is used for 2. What you need to know before the medicine radiolabelled with Cuprymina is used 3. How the medicine radiolabelled with Cuprymina is used 4. Possible side effects 5. How to store Cuprymina 6. Contents of the pack and other information 1. WHAT CUPRYMINA IS AND WHAT IT IS USED FOR Cuprymina is not a medicine _ _ and it is not intended to be used on its own. Cuprymina is a type of medicine called a radiopharmaceutical precursor. It contains the active substance copper ( 64 Cu) chloride. Copper-64 is a radioactive form of the chemical element copper, which emits the radiation needed for certain procedures that may be carried out on you. Cuprymina is used for radiolabelling, a technique in which a substance is tagged (radiolabelled) with a radioactive compound. Cuprymina is used to label certain medicines that have been specially developed and authorised for use with the active substance copper ( 64 Cu) chloride. These medicines act as a carrier to take the radioactivity to where it is needed. These may be substances that have been designed to recognise a particular type of cell in the body, including tumour cells. The use of Copper-64-labelled medicines involves 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 radiopharmac Izlasiet visu dokumentu
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Cuprymina 925 MBq/mL radiopharmaceutical precursor, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution contains 925 MBq of copper ( 64 Cu) chloride at calibration time (01h00 a.m. Central European Time [CET]), corresponding to at least 0.25 micrograms of Copper-64. The calibration time is set between the end of the synthesis time and the expiry time. Each vial contains an activity ranging from 925 MBq to 2,770 MBq (at calibration time) which corresponds to an amount of 0.25 to 0.75 micrograms of Copper-64. The volume varies from 1 to 3 mL. The minimal specific activity is 3,700 MBq Copper-64/micrograms of Copper at the expiry date and time. Copper-64 has a half-life of 12.7 hours. Copper-64 decays by an emission of β + (17.6 %) with a maximum energy of 0.66 MeV, an emission of β - (38.5 %) with a maximum energy of 0.58 MeV and electronic capture (43.9 %). Copper-64 decays in stable Nickel 64 Ni (61 %) by an emission of β + (18 %) or by an electronic capture (43 %). Copper-64 decays also in stable Zinc ( 64 Zn) by emission of β - (39 %). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Radiopharmaceutical precursor, solution. Clear, colourless solution, free of particulate matter. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cuprymina is a radiopharmaceutical precursor. It is not intended for direct use in patients. This medicinal product must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cuprymina is only to be used by specialists experienced with _in vitro_ radiolabelling Posology The quantity of Cuprymina required for radiolabelling and the quantity of Copper-64-labelled medicinal product that is subsequently administered will depend on the medicinal product radiolabelled and its intended use. Refer to the Summary of Product Cha Izlasiet visu dokumentu