Quốc gia: Na Uy
Ngôn ngữ: Tiếng Na Uy
Nguồn: Statens legemiddelverk
Dimerkaptosuccininsyre
Curium Netherlands B.V.
V09EA01
Dimerkaptosuccininsyre
1.2 mg
Preparasjonssett til radioaktive legemidler
Hetteglass 5x1.2 mg
C
Markedsført
1999-11-01
_18 CON 4341 Norway SPC 09112023_tracked.docx _ SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Technescan DMSA 1.2 mg kit for radiopharmaceutical preparation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains: Succimer (or dimercaptosuccinic acid or DMSA) 1.2 mg 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 lyophilisate. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. After radiolabelling with sodium pertechnetate ( 99m Tc) solution, the solution of technetium ( 99m Tc) succimer obtained is indicated in adults and children for: Study of renal cortex morphology Study of individual kidney function Location of ectopic kidney. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults _ In adults, the recommended activity of technetium ( 99m Tc) succimer, for a patient of average weight (70 kg), is 30 to 120 MBq. Other activities may be justifiable. It should be noted that in each country physicians should follow the Diagnostic Reference Levels and the rules set up by local law. _Elderly population _ No special dosage regimen for elderly patients is required. _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 activities to be administered to children and to _ _ adolescents may be calculated according to the European Association of Nuclear Medicine dosage card (EANM 2016) by using the following formula: _A[MBq]Administered_ = _Baseline Activity _ x _Multiple_ (with a baseline activity of 6.8) A minimum activity of 18.5 MBq is recommended in order to obtain images of sufficient quality. The resulting Đọc toàn bộ tài liệu