País: Singapur
Idioma: anglès
Font: HSA (Health Sciences Authority)
Germanium (68Ge) chloride; gallium (68Ga) chloride
LABGISTICS ASIA PTE LTD
V09X
INJECTION, SOLUTION (RADIOPHARMACEUTICAL)
Germanium (68Ge) chloride 0.74 – 1.85 GBq; gallium (68Ga) chloride > 60 % of the loaded activity
OTHERS
Prescription Only
Eckert & Ziegler Radiopharma GmbH
ACTIVE
2023-08-23
_August 2023, GalliaPharm PI _ _1 / 24 _ PACKAGE INSERT 1. PRODUCT NAME 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 with 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 %) 1,077.34 keV (3.22 %) 1,260.97 keV (0.09 %) 1,883.16 keV (0.14 %) beta+ Energy max. Energy 352.60 keV 821.71 keV (1.20%) 836.00 keV 1,899.01 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 since the previous elution. If mother and daughter nuclides Llegiu el document complet