البلد: قبرص
اللغة: اليونانية
المصدر: Φαρμακευτικών Υπηρεσιών του Υπουργείου Υγείας
IOBENGUANE (131 I)
GE HEALTHCARE BUCHLER GMBH & CO KG (0000003641) GIESELWEG 1, BRAUNSCHWEIG, 38110
V09IX02
IOBENGUANE (131I)
9.25-18.5MBQ/ML
SOLUTION FOR INJECTION
IOBENGUANE (131 I) (8000003407) 9,25MBq
INTRAVENOUS USE
Ειδική άδεια άρθρο 126A
Νομικό καθεστώς: Με Ιατρική Συνταγή; 1 VIAL X 4ML X 37MBq () 1 VIAL - Εγκεκριμένο - Με Ιατρική Συνταγή
PACKAGE LEAFLET: INFORMATION FOR THE HEALTHCARE PROFESSIONAL ( 131 I) META-IODOBENZYL- GUANIDINE FOR DIAGNOSTIC USE, GE HEALTHCARE, SOLUTION FOR INTRAVENOUS INJECTION 14473882 IBS6711-DK0119-SPC ( 131 I) Meta-Iodobenzylguanidine for Diagnostic Use, GE Healthcare 2. QUALITATIVE AND QUANTITATIVE COMPOSITION [ 131 I]Iobenguane: 9.25-18.5MBq/ml (0.05-0.5mg/ml). Summary of the physical characteristics of the radioactive isotope in the active substance: Iodine-131: physical half-life 8.02 days. The most important radiation emissions are as below: Energy level Abundance %) b -247 keV 1.8 b -334 keV 7.2 b -606 keV 89.7 b -806 keV 0.7 g -364 keV 82.0 Excipients with known effect: • Benzyl alcohol: 10 mg/ml • Sodium: 3.54 mg/ml For the full list of excipients, see section 6.1. sap1193219_ch14473882_x_gehealthcare_PP28512.qxp_# 30.01.19 11:12 Seite 1 3. PHARMACEUTICAL FORM Solution for intravenous injection Clear colourless solution 4. CLINICAL PARTICULARS 4.1 INDICATION This medicinal product is for diagnostic use only. Calculation of a therapeutic [ 131 I]iobenguane dose from a prior tracer-dose. The sensitivity to diagnostic visualisation, and therefore also to therapeutic efficacy, is different for the listed pathologic entities. Pheochromocytomas and neuroblastomas are sensitive in approximately 90 % of patients, carcinoids in 70 % and medullary carcinomas of the thyroid glands (MCT) in only 35 %. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults_ "Tracer"-dose to acquire dosimetric information (20-40 MBq). Distribution measurement prior to administration of a therapeutic dose is recommended in order to establish the retention time of the radiopharma- ceutical in organs, tumour tissue and normal structures. _Elderly population_ No special dosage scheme is required for the elderly patient. _Paediatric population_ The recommended dosages are identical for children and adults. Metaiodobenzylguanidine ( 131 I) for Diagnostic Use is contraindicated in premature babies and neonates. Method of administration The اقرأ الوثيقة كاملة