국가: 싱가포르
언어: 영어
출처: HSA (Health Sciences Authority)
Sodium Molybdate (99Mo); Sodium pertechnetate (99mTc)
QT INSTRUMENTS (S) PTE LTD
V09FX01
2.15, 4.3, 6.45, 8.6, 10.75, 12.9, 17.2, 21.5, 25.8, 30.1, 34.4, 43 (GBq)
SOLUTION
Sodium Molybdate (99Mo) 2.15, 4.3, 6.45, 8.6, 10.75, 12.9, 17.2, 21.5, 25.8, 30.1, 34.4, 43 (GBq); Sodium pertechnetate (99mTc) 2.08,4.16,6.24,8.32,10.4,12.47,16.63,20.79,24.95,29.11,33.26,41.58 (Gbq)
INTRAVENOUS
Prescription Only
Curium Netherlands B.V.
ACTIVE
2012-01-19
DRN 4329 ULTRA-TECHNEKOW FM SINGAPORE PAGE 1 OF 5 04329706BYS04a / 10 CON 4329 Singapore SPC 01112023 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ultra-Technekow FM 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Technetium ( 99m Tc) is produced by means of a ( 99 Mo/ 99m Tc) generator and decays with the emission of gamma radiation with a mean energy of 140 keV and a half-life of 6 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. A sterile generator containing the parent isotope 99 Mo, adsorbed to an aluminium oxide column. 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: GBQ (MCI) GBQ (MCI) 2.15 (58) 17.20 (465) 4.30 (116) 21.50 (581) 6.45 (174) 25.80 (697) 8.60 (232) 30.10 (814) 10.75 (291) 34.40 (930) 12.90 (349) 43.00 (1162) For a 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. The eluate from the generator (Sodium Pertechnetate ( 99m Tc) Injection Ph. Eur.) may be used as a reagent for labelling of various carrier compounds supplied as kits or administered directly in-vivo. A. When administered intravenously, the sterile sodium pertechnetate ( 99m Tc) solution is used as a diagnostic aid in the following: • THYROID SCINTIGRAPHY: direct imaging and measurement of thyroid uptake to give information on the size, position, nodularity and function of the gland in thyroid disease. • SALIVARY GLAND SCINTIGRAPHY: to assess salivary gland function and duct patency. • LOCATION OF ECTOPIC GASTRIC MUCOSA: Meckel's diverticulum. • CEREBRAL SCINTIGRAPHY: to identify breaches in the blood- brain barrier caused by tumour, infarction, haemorrhage and oedema, when no other methods are available. B. When used in conjunction with pre-treatment with a reducing 전체 문서 읽기