Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
Tetrakis (2-methoxy isobutyl isonitrile) copper (i) tetrafluorolborate
CIS bio International
V09GA; V09GA01
Tetrakis (2-methoxy isobutyl isonitrile) copper (i) tetrafluorolborate
1 milligram(s)
Kit for radiopharmaceutical preparation
Product subject to Restricted Prescription (C)
Technetium (99mTc) compounds; technetium (99mTc) sestamibi
Marketed
2008-12-12
1 T3069p_IE 12/2021 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT STAMICIS 1 MG KIT FOR RADIOPHARMACEUTICAL PREPARATION [Tetrakis (2-methoxyisobutyl isonitrile) copper (I)] tetrafluoroborate READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure. - If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What STAMICIS is and what it is used for 2. What you need to know before STAMICIS is used 3. How STAMICIS is used 4. Possible side effects 5. How STAMICIS is stored 6. Contents of the pack and other information 1. WHAT STAMICIS IS AND WHAT IT IS USED FOR This medicine is a radiopharmaceutical product for diagnostic use only. STAMICIS contains a substance called [Tetrakis (2-methoxyisobutyl isonitrile) copper (I)] tetrafluoroborate which is used to study the heart function and blood flow (myocardial perfusion) by making an image of the heart (scintigraphy), for example in the detection of heart attacks (myocardial infarctions) or when a disease causes reduced blood supply to (a part of) the heart muscle (ischaemia). STAMICIS is also used in the diagnosis of breast abnormalities in addition to other diagnostic methods when the results are unclear. STAMICIS can also be used to find the position of overactive parathyroid glands (glands that secrete the hormone that controls blood calcium levels). After STAMICIS is injected, it temporarily collects in certain parts of the body. This radiopharmaceutical substance contains a small amount of radioactivity, which can be detected from outside of the body by using special cameras. You nuclear medicine doctor will then take an image (scintigraphy) of the concerned organ which can give your doctor valuable information about the structure an Baca dokumen lengkapnya
Health Products Regulatory Authority 20 December 2023 CRN00DPTQ Page 1 of 13 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT STAMICIS 1mg 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. 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 secondaryhyperparathyroidism, and in patients with primary hyperparathyroidismscheduled 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 activity range for intravenous administration to an adult patient of average weight (70 kg) is for: _Diagnosis of reduced Baca dokumen lengkapnya