Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Tetrakis (2-methoxyisobutyl isonitrile) copper (I) tetrafluoroborate
QUANTARAD TECHNOLOGIES SDN BHD
Tetrakis (2-methoxyisobutyl isonitrile) copper (I) tetrafluoroborate
1mg mcg/mL
CIS Bio International
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT STAMICIS 1 mg kit for radiopharmaceutical preparation 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 1 mg [Tetrakis (2-methoxyisobutyl isonitrile) copper (I)] tetrafluoroborate. The radionuclide is not part of the kit. Excipients with known effect: One ml of solution contains 4.5 mg of sodium For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Kit for radiopharmaceutical preparation. White powder. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. This is indicated for adults. For paediatric population see section 4.2. After radiolabelling with sodium pertechnetate ( 99m Tc) solution, the solution of technetium ( 99m Tc) sestamibi obtained is indicated for: • MYOCARDIAL PERFUSION SCINTIGRAPHY for the detection and localisation of coronary artery disease (angina pectoris 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. CIS bio international, Member of IBA Molecular group of companies T3069nE-project 04/2017 2 • SCINTIMAMMOGRAPHY FOR THE DETECTION OF SUSPECTED BREAST CANCER when mammography is equivocal, inadequate or indeterminate. • LOCALISATION OF HYPERFUNCTIONING PARATHYROID TISSUE in patients with recurrent or persistent disease in both primary and secondary hyperparathyroidism, and in patients with primary hyperparathyroidism scheduled to undergo initial surgery of the parathyroid glands. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Adults and elderly population _ Posology may vary depending on gamma camera characteristics and reconstruction modalities. The injection of activities greater than local DRLs (Diagnostic Reference Levels) should be justified. The recommended activity range for intravenous administration to an adult patient of Baca dokumen lengkap