Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
GERMANIUM (68GE) CHLORIDE; Gallium (68Ga) Chloride
Eckert & Ziegler Radiopharma GmbH
V09X
GERMANIUM (68GE) CHLORIDE; Gallium (68Ga) Chloride
0.74-1.85 gigabecquerel(s)
Radionuclide generator
Product subject to prescription which may not be renewed (A)
OTHER DIAGNOSTIC RADIOPHARMACEUTICALS
Marketed
2017-09-01
1 B. PACKAGE LEAFLET FOR RADIOPHARMACEUTICALS 2 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT GalliaPharm, 0.74 -1.85 GBq, radionuclide generator Gallium ( 68 Ga) chloride solution 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 GalliaPharm is and what it is used for 2. What you need to know before the gallium ( 68 Ga) chloride solution obtained with GalliaPharm is used 3. How gallium ( 68 Ga) chloride solution obtained with GalliaPharm is used 4. Possible side effects 5. How GalliaPharm is stored 6. Contents of the pack and other information 1. WHAT GALLIAPHARM IS AND WHAT IT IS USED FOR This medicine is a radiopharmaceutical product for diagnostic use only. This medicine is a radiopharmaceutical product not intended for direct use in patients. GalliaPharm is a germanium ( 68 Ge) / gallium ( 68 Ga) radionuclide generator, a device used to obtain a solution of gallium ( 68 Ga) chloride. The obtained gallium ( 68 Ga) chloride solution is used for radiolabelling, a technique in which a substance is tagged (radiolabelled) with a radioactive compound, here 68 Ga. GalliaPharm is used to label certain medicines that have been specially developed and approved for the use with the active substance gallium ( 68 Ga) chloride. These medicines act as carriers to take the radioactive 68 Ga 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 (cancer). The low amount of radioactivity administered can be detected outside of the body by special cameras to obtain images of the body. Please refer to the package leaflet of the me Aqra d-dokument sħiħ
Health Products Regulatory Authority 25 January 2021 CRN00C4HT Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT GalliaPharm 0.74 – 1.85 GBq radionuclide generator 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The radionuclide generator contains germanium ( 68 Ge) as mother nuclide which decays to the daughter nuclide gallium ( 68 Ga). The germanium ( 68 Ge) used for the production of the ( 68 Ge/ 68 Ga) generator is carrier-free. The total radioactivity due to germanium ( 68 Ge) and gamma-ray-emitting impurities is not more than 0.001%. The GalliaPharm 0.74 – 1.85 GBq radionuclide generator is a system for the elution of gallium ( 68 Ga) chloride solution for radiolabelling in accordance Ph. Eur. 2464. This solution is eluted from a column on which the mother nuclide germanium ( 68 Ge), parent of gallium ( 68 Ga), is fixed. The system is shielded. Physical characteristics of both mother and daughter nuclides are summarized in table 1. TABLE 1: PHYSICAL CHARACTERISTICS OF GERMANIUM ( 68 GE) AND GALLIUM ( 68 GA) PHYSICAL CHARACTERISTICS OF 68 GE 68 GA Half-life 270.95 days 67.71 minutes Type of physical decay Electron capture Positron emission X-rays 9.225 keV (13.1 %) 9.252 keV (25.7 %) 10.26 keV (1.64 %) 10.264 keV (3.2 %) 10.366 keV (0.03 %) 8.616 keV (1.37 %) 8.639 keV (2.69 %) 9.57 keV (0.55 %) Gamma-rays 511 keV (178.28 %) 578.55 keV (0.03 %) 805.83 keV (0.09 %) 1077.34 keV (3.22 %) 1260.97 keV (0.09 %) 1883.16 keV (0.14 %) beta+ Energy max. Energy 352.60 keV 821.71 keV (1.20 %) 836.00 keV 1899.01 keV (87.94 %) Data derived from nudat (www.nndc.bnl.gov) 5 ml of the eluate contains a potential maximum of 1850 MBq of 68 Ga and 18.5 kBq of 68 Ge (0.001 % breakthrough in the eluate). This corresponds to 1.2 ng of gallium and 0.07 ng of germanium. The quantity of gallium ( 68 Ga) chloride solution for radiolabelling Ph. Eur. that may be eluted from the generator is dependent on the quantity of germanium ( 68 Ge) present, the volume of eluent used (typically 5 ml) and the lapsed time Aqra d-dokument sħiħ