Land: Norge
Språk: norsk
Kilde: Statens legemiddelverk
Betiatid
Curium Netherlands B.V.
V09CA03
Betiatid
1 mg
Preparasjonssett til radioaktive legemidler
Hetteglass 5x1 mg
C
Markedsført
2006-01-31
SUMMARY OF PRODUCT CHARACTERISTICS FOR TECHNESCAN MAG3, 1 MG KIT FOR RADIOPHARMACEUTICAL PREPARATION 1. NAME OF THE MEDICINAL PRODUCT Technescan MAG3, 1 mg kit for radiopharmaceutical preparation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1 mg betiatide. 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. Powder for solution for injection. Off-white to slightly yellow lyophilizate. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. After reconstitution and labelling with sodium pertechnetate ( 99m Tc) solution, the diagnostic agent technetium ( 99m Tc) mertiatide may be used for the evaluation of nephrological and urological disorders in particular for the study of morphology, perfusion, function of the kidney and characterisation of urinary outflow. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ The recommended activity for an adult weighing 70 kg is 40 to 200 MBq, depending on the pathology to be studied and the method to be used. Other activities may be justifiable. Studies of renal blood flow or transport through the ureters generally require a larger dose than studies of intra-renal transport, whereas renography requires smaller activities than sequential scintigraphy. _Elderly population _ No special dosage-scheme is required for the elderly patient. _Renal impairment _ Careful consideration of the activity to be administered is required since an increased radiation exposure is possible in these patients. _Paediatric population _ The use in children and adolescents has to be considered carefully, based upon clinical needs and assessing the risk/benefit ratio in this patient group. The activity to be administered in children and adolescents is determined according to the EANM dosage card (2016) using the following formula: _The activity to be administered A[MBq] = Baseline activity (of 11.9 MBq) x Multiple _ The activities Les hele dokumentet