देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
SODIUM PERTECHNETATE (99M TC)
CIS bio International
V09FX01
SODIUM PERTECHNETATE (99M TC)
%v/v
Unknown
Product subject to Restricted Prescription (C)
Various thyroid diagnostic radiopharmaceuticals
Authorised
1998-04-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ELUMATIC III 2-20 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 to 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 yield and 24 hours time from previous elution and taking into account that branching ratio of 99 Mo is about 87%: Excipient with known effect: Each mL of sodium pertechnetate ( 99m Tc) solution contains 3.6 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. 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 solution. Thyroid scintigraphy: direct imaging and measurement of thyroid uptake to give information on the size, position, nodularity and function of the gland in case of thyroid disease. Salivary gland scintigraphy: diagnosis of chronic sialadenitis (e.g. Sjögren's Syndrom) as well as assessment of salivary gland function and duct patency in salivary glands disorders and monitoring of the response to therapeutic interventions (in particular radioiodine therapy). 99m Tc activi पूरा दस्तावेज़ पढ़ें