Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
lutetium (177Lu) chloride
ITM Medical Isotopes GmbH
V10X
lutetium (177 Lu) chloride
Therapeutic radiopharmaceuticals
Radionuclide Imaging
EndolucinBeta is a radiopharmaceutical precursor, and it is not intended for direct use in patients. It is to be used only for the radiolabelling of carrier molecules that have been specifically developed and authorised for radiolabelling with Lutetium (177Lu) chloride.
Revision: 8
Authorised
2016-07-06
22 B. PACKAGE LEAFLET 23 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ENDOLUCINBETA 40 GBQ/ML RADIOPHARMACEUTICAL PRECURSOR, SOLUTION lutetium ( 177 Lu) chloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THE MEDICINE COMBINED WITH ENDOLUCINBETA 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 EndolucinBeta is and what it is used for 2. What you need to know before the medicine radiolabelled with EndolucinBeta is used 3. How the medicine radiolabelled with EndolucinBeta is used 4. Possible side effects 5. How EndolucinBeta is stored 6. Contents of the pack and other information 1. WHAT ENDOLUCINBETA IS AND WHAT IT IS USED FOR EndolucinBeta is not a medicine and it is not intended to be used on its own. It has to be used in combination with other medicines (carrier medicines). EndolucinBeta is a type of product called a radiopharmaceutical precursor. It contains the active substance Lutetium ( 177 Lu) chloride which gives off beta-radiation, allowing a localised radiation effect. This radiation is used to treat certain diseases. EndolucinBeta has to be combined with a carrier medicine in a process called radiolabelling before administration. The carrier medicine then takes the EndolucinBeta to the disease site in the body. These carrier medicines have been specially developed for use with Lutetium ( 177 Lu) chloride and may be substances that have been designed to recognise a particular type of cell in the body. The use of a medicine radiolabelled with EndolucinBeta does involve exposure to radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit that you will obtain from the procedure with the radiopharmaceutical outweigh Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT EndolucinBeta 40 GBq/mL radiopharmaceutical precursor, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL of solution contains 40 GBq Lutetium ( 177 Lu) chloride on activity reference time (ART), corresponding to 10 micrograms of Lutetium ( 177 Lu) (as chloride). The ART is 12:00 pm (noon) on the scheduled day of radiolabelling as indicated by the customer and can be within 0 to 7 days starting from the day of manufacture. Each 2 mL vial contains an activity ranging from 3 – 80 GBq, corresponding to 0.73 – 19 micrograms of Lutetium ( 177 Lu), at ART. The volume is 0.075 – 2 mL. Each 10 mL vial contains an activity ranging from 8 – 150 GBq, corresponding to 1.9 – 36 micrograms of Lutetium ( 177 Lu), at ART. The volume is 0.2 – 3.75 mL. The theoretical specific activity is 4,110 GBq/mg of Lutetium ( 177 Lu). The specific activity of the medicinal product at ART is indicated on the label and always greater than 3,000 GBq/mg. Non carrier added (n.c.a.) Lutetium ( 177 Lu) chloride is produced by the irradiation of highly enriched (> 99 %) Ytterbium ( 176 Yb) in neutron sources with a thermal neutron flux between 10 13 and 10 16 cm −2 s −1 . The following nuclear reaction is ongoing in the irradiation: 176 Yb(n, γ) 177 Yb → 177 Lu The produced Ytterbium ( 177 Yb) with a half-life of 1.9 h decays to Lutetium ( 177 Lu). In a chromatographic process, the accumulated Lutetium ( 177 Lu) is separated chemically from the original target material. Lutetium ( 177 Lu) emits both medium-energy beta particles and imageable gamma photons, and has a half-life of 6.647 days. The primary radiation emissions of Lutetium ( 177 Lu) are shown in Table 1. TABLE 1: LUTETIUM ( 177 LU) PRINCIPLE RADIATION EMISSION DATA Radiation Energy (keV)* Abundance (%) Beta (β − ) 47.66 11.61 Beta (β − ) 111.69 9.0 Beta (β − ) 149.35 79.4 Gamma 112.9498 6.17 Gamma 208.3662 10.36 * mean energies are listed for beta particles Lutetium ( 177 Lu) Aqra d-dokument sħiħ