Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
succimer, Quantity: 1 mg
Global Medical Solutions Australia Pty Limited T/A Radpharm Scientific
Succimer
Injection, powder for
Excipient Ingredients: inositol; ascorbic acid; stannous chloride
Intravenous
5x8mL vials
Not scheduled. Not considered by committee
INDICATIONS AS AT 25 SEPTEMBER 1996: Technetium (99mTc) succimer may be used as a static renal imaging pharmaceutical and is particularly suited for evaluation of renal cortex, deliniation of renal space occupying lesions, determination of intrarenal function, distribution and identification of ectopic renal sites.
Visual Identification: Lyophilised white powder; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 1 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
1991-09-05
RADPHARM L4.2 SCIENTIFIC DMSA RADPHARM KIT FOR THE PREPARATION OF TECHNETIUM[ 99M TC] SUCCIMER INJECTION FOR RENAL IMAGING PRODUCT DATA AUST R 14326 DESCRIPTION This Kit consists of sterile, pyrogen free lyophilised ingredients which need reconstitution with sodium pertechnetate[ 99m Tc] injection to produce a technetium[ 99m Tc] succimer complex suitable for renal imaging. The precise structure of the technetium[ 99m Tc] succimer complex is not known at this time. Technetium[ 99m Tc] succimer is a diagnostic pharmaceutical administered by intravenous injection. CONTENTS AND PRESENTATION DMSA Radpharm is supplied as a carton of 5 sterile, pyrogen free, vacuum sealed multidose 8 mL vials. Each vial contains 1 mg succimer (_meso-_2,3-dimercaptosuccinic acid), 0.4 mg stannous chloride anhydrous, 0.7 mg ascorbic acid and 50.0 mg inositol as a lyophilised powder. The product contains no preservatives. PHYSICAL CHARACTERISTICS OF TECHNETIUM-99M Technetium-99m with a physical half life of 6 hours decays by isomeric transition to technetium-99. Photons associated with this transition that are useful for detection and imaging studies are listed in Table 1. Table 1. Principal Radiation Emission Data Principal Radiation Mean Percent per Disintegration Mean Energy (keV) Gamma-2 89.1 140.5 Reference: D A Weber et al. "MIRD: Radionuclide and decay schemes", The Society of Nuclear Medicine Inc. New York, 1989. Table 2. Physical Decay Chart for Technetium-99m Hours Fraction Remaining Hours Fraction Remaining 0 1.000 7 0.445 1 0.891 8 0.397 2 0.794 9 0.354 3 0.707 10 0.315 4 0.630 11 0.281 5 0.561 12 0.250 6 0.500 EXTERNAL RADIATION The specific gamma ray constant for technetium-99m is 0.19 mGy/MBq-h at 1 cm. The first half value thickness of lead (Pb) for technetium-99m is 0.2 mm. Attenuation by lead is given in Table 3. Table 3. Radiation Attenuation by Lead Shielding Shield Thickness mm Pb Coefficient of Attenuation 0.95 0.1 1.8 0.01 2.7 0.001 3.6 0.0001 PHARMACOLOGY Technetium[ 99m Tc] succimer exhibits insignificant glomerul Belgenin tamamını okuyun