Negara: Norwegia
Bahasa: Norwegia
Sumber: Statens legemiddelverk
Kalsiumtrinatriumpentetat
Curium Netherlands B.V.
V09CA01
Kalsiumtrinatriumpentetat
Preparasjonssett til radioaktive legemidler
Hetteglass 5x25 mg
C
Markedsført
1999-11-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Technescan DTPA 20.8 mg kit for radiopharmaceutical preparation. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 20.8 mg pentetic acid. To be reconstituted with sodium pertechnetate ( 99m Tc) for the preparation of the diagnostic agent: Technetium ( 99m Tc) pentetate. The radionuclide is not part of the kit. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Kit for radiopharmaceutical preparation. Off-white to slightly yellow freeze-dried powder for solution for injection, oral use or inhalation. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. After reconstitution with sodium pertechnetate ( 99m Tc) solution, the solution of technetium ( 99m Tc) pentetate is indicated for: a) After intravenous administration for: Measurement of glomerular filtration rate Renal perfusion and function and urinary tract studies. Cerebral angioscintigraphy (as an alternative method when computed tomography and/or magnetic resonance imaging are not available). b) After inhalation of the nebulized technetium ( 99m Tc) pentetate for: Lung ventilation imaging. c) After oral administration of the technetium ( 99m Tc) pentetate for: Detection of gastroesophageal reflux and liquid gastric emptying study. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Adults and the elderly population _ The following administered activities are recommended (other activities may be justifiable): _For intravenous use: _ Measuring glomerular filtration rate from plasma: 7 - 18 MBq. Renal scintigraphy: 40 - 400 MBq. Cerebral angioscintigraphy: 185 – 740 MBq. _For inhalation: _ Lung ventilation imaging: 500-1000 MBq deposited in the nebuliser. 50 - 100 MBq in the lung. _For oral use: _ Detection of gastroesophageal reflux and liquid gastric emptying study: 10 - 20 MBq. Technetium ( 99m Tc) pentetate is mixed with an appropriate volume (30 to 240 mL) of liquid car Baca dokumen lengkapnya