Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
lutetium (177Lu) chloride
I.D.B. Radiopharmacy B.V.
V10
lutetium (177 Lu) chloride
Therapeutic radiopharmaceuticals
Radionuclide Imaging
Lumark is a radiopharmaceutical precursor. It is not intended for direct use in patients. This medicinal must be used only for the radiolabelling of carrier molecules, which have been specifically developed and authorised for radiolabelling with this radionuclide.
Revision: 9
Authorised
2015-06-18
21 B. PACKAGE LEAFLET 22 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT LUMARK 80 GBQ/ML RADIOPHARMACEUTICAL PRECURSOR SOLUTION Lutetium ( 177 Lu) chloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THE MEDICINE COMBINED WITH LUMARK 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 Lumark is and what it is used for 2. What you need to know before the medicine radiolabelled with Lumark is used 3. How to use the medicine radiolabelled with Lumark 4. Possible side effects 5. How to store Lumark 6. Contents of the pack and other information 1. WHAT LUMARK IS AND WHAT IT IS USED FOR Lumark is not a medicine and it is not intended to be used on its own. Lumark is a so-called radiopharmaceutical precursor. It contains the active substance lutetium ( 177 Lu) chloride. Lumark is used for radiolabelling medicines, a technique in which medicines are tagged (radiolabelled) with a radioactive form of the element lutetium, known as lutetium ( 177 Lu). These medicines can then be used in medical procedures to carry radioactivity to where it is needed in the body such as sites of tumour cells. Lumark is only used to radiolabel medicines that have been specifically developed for use with the active substance lutetium ( 177 Lu) chloride. The use of lutetium ( 177 Lu)-labelled medicines 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. Please refer to the package leaflet of the medicine that is to be radiolabelled with Lumark. 2. WHAT YOU NEED TO KNOW BEFORE THE MEDICINE RADIOLABELLED WITH L Lesen Sie das vollständige Dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Lumark 80 GBq/mL radiopharmaceutical precursor, solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution contains 80 GBq lutetium ( 177 Lu) chloride at activity reference time (ART), corresponding to at most a maximum of 160 microgram of lutetium. The ART is defined as the end of production. Each vial contains a volume varying from 0.1 to 5 mL corresponding to an activity ranging from 8 to 400 GBq (at ART) . The minimal specific activity is 500 GBq/mg lutetium ( 177 Lu) at the ART. Lutetium ( 177 Lu) has a half-life of 6.647 days. Lutetium ( 177 Lu) is produced by neutron irradiation of enriched lutetium ( 176 Lu). Lutetium ( 177 Lu) decays by β - -emission to stable Hafnium ( 177 Hf), with the most abundant β - (79.3%) having a maximum energy of 0.497 MeV. Also low gamma energy is emitted, for instance at 113 keV (6.2%) and 208 keV (11%). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Radiopharmaceutical precursor, solution. Clear, colourless solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Lumark is a radiopharmaceutical precursor. It is not intended for direct use in patients. It 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 Lumark is only to be used by specialists experienced with _in vitro_ radiolabelling. Posology The quantity of Lumark required for radiolabelling and the quantity of the medicinal product to be radiolabelled with lutetium( 177 Lu) that is subsequently administered will depend on the medicinal product to be radiolabelled and its intended use. Refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled. _ _ 3 _Paediatric population _ For more information concerning the paediatric use of lutetium ( 177 Lu)-labelled medicinal products refer to the Lesen Sie das vollständige Dokument