ประเทศ: นอร์เวย์
ภาษา: นอร์เวย์
แหล่งที่มา: Statens legemiddelverk
Natriummolybdat Mo-99 omdannet til natriumperteknetat Tc-99m
Curium Netherlands B.V.
V09FX01
Natriummolybdat Mo-99 omdannet til natriumperteknetat Tc-99m
Radionuklidegenerator
Radionukleidegenerator 43 GBq
C
Markedsført
2000-03-14
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ultra-TechneKow FM, 2,15-43,00 GBq, radionuclide generator 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Sodium pertechnetate ( 99m Tc) injection is produced by means of a ( 99 Mo/ 99m Tc) generator. Technetium ( 99m Tc) decays with the emission of gamma radiation with a mean energy of 140 keV and a half-life of 6,01 hours to technetium ( 99 Tc) which, in view of its long half-life of 2.13 x 10 5 years can be regarded as quasi stable. The radionuclide generator containing the parent isotope 99 Mo, adsorbed on a chromatographic column delivers sodium pertechnetate ( 99m Tc) injection in sterile solution. The 99 Mo on the column is in equilibrium with the formed daughter isotope 99m Tc. The generators are supplied with the following 99 Mo activity amounts at activity reference time which deliver the following technetium ( 99m Tc) amounts, assuming a 100% theoretical elution yield and 24 hours from previous elution and taking into account that branching ratio of 99 Mo is about 87%: The technetium ( 99m Tc) amounts available by a single elution depend on the real yields of the kind of generator used itself declared by manufacturer and approved by National Competent Authority. Excipient(s) with known effect Each mL of sodium pertechnetate ( 99m Tc) solution contains 3.5 mg of sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Radionuclide generator. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. 99m Tc activity (maximum theoretical elutable activity at ART, 06.00 h CET) 1.90 3.81 5.71 7.62 9.53 11.43 15.24 19.05 22.86 26.67 30.48 38.10 GBq 99 Mo activity (at ART, 06.00 h CET) 2.15 4.30 6.45 8.60 10.75 12.90 17.20 21.50 25.80 30.10 34.40 43.00 GBq The eluate from the radionuclide generator (sodium pertechnetate ( 99m Tc) Injection) is indicated for: labelling of various kits for radiopharmaceutical preparation developed and approved for radiolabelling with such solu อ่านเอกสารฉบับเต็ม