Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
TETRAKIS (2-METHOXY ISOBUTYL ISONITRILE) COPPER (I) TETRAFLUOROLBORATE
DRAXIMAGE (UK) Limited
TETRAKIS (2-METHOXY ISOBUTYL ISONITRILE) COPPER (I) TETRAFLUOROLBORATE
1 Milligram
Kit for radiopharmaceutical preparation
Product subject to prescription which may not be renewed (A)
Withdrawn
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT DRAXMIBI 1 mg kit for radiopharmaceutical preparation 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 vial contains: Active substance Tetrakis(2-methoxyisobutylisonitrile)copper(I) Tetrafluoroborate 1 mg Excipients: This medicinal product contains 0.61 mg of Sodium per vial. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Kit for radiopharmaceutical preparation. Lyophilized, white powder. To be reconstituted with sodium pertechnetate ( 99m Tc) solution for injection (not included in this kit). 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. After reconstitution with sodium technetium pertechnetate ( 99m Tc) solution for injection, the solution of technetium ( 99m Tc) sestamibi obtained is indicated for: MYOCARDIAL PERFUSION SCINTIGRAPHY Detection and localization of coronary artery disease and myocardial infarction. ASSESSMENT OF GLOBAL VENTRICULAR FUNCTION First-pass technique for determination of ejection fraction and/or ECG-triggered, gated SPECT for evaluation of left ventricular ejection fraction, volumes and regional wall motion. SCINTI-MAMMOGRAPHY FOR THE DETECTION OF SUSPECTED BREAST CANCER Detection of suspected breast cancer when mammography is equivocal, inadequate or indeterminate LOCALISATION OF HYPERFUNCTIONING PARATHYROID TISSUE in patients with recurrent or persistent hyperparathyroidism, and in patients scheduled to undergo surgery of the parathyroid glands. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 19/08/2011_ _CRN 2094519_ _page number: 1_ 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For intravenous use. The suggested activity range for intravenous administration to a Lugege kogu dokumenti