Country: Norway
Bahasa: Norway
Sumber: Statens legemiddelverk
Tetrofosmin
GE HEALTHCARE AS
V09GA02
tetrofosmin
Pulver til injeksjonsvæske, oppløsning
Hetteglass 2x0.23 mg
C
Markedsført
1994-10-01
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT MYOVIEW 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 230 micrograms of tetrofosmin. Excipients with known effect: The reconstituted injection contains 3.6 – 3.7 mg/ml sodium. For the full list of excipients, see section 6.1. Myoview is reconstituted with Sodium Pertechnetate ( 99m Tc) Injection Ph.Eur. (not included in this kit) to prepare technetium ( 99m Tc) tetrofosmin injection. 3. PHARMACEUTICAL FORM Kit for radiopharmaceutical preparation. A white powdery solid. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. After reconstitution with Sodium Pertechnetate ( 99m Tc) Injection the product is indicated in adults for: MYOCARDIAL IMAGING Myoview is a myocardial perfusion agent indicated as an adjunct in the diagnosis and localization of myocardial ischaemia and/or infarction. In patients undergoing myocardial perfusion scintigraphy, ECG-gated SPECT can be used for assessment of left ventricular function (left ventricular ejection fraction and wall motion). BREAST TUMOUR IMAGING Myoview is indicated as an adjunct to the initial assessment (e.g. palpation, mammography, or alternative imaging modalities and/or cytology) in the characterisation of malignancy of suspected breast lesions where all these other recommended tests were inconclusive. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults MYOCARDIAL IMAGING 2 Patients should be requested to fast overnight or to have only a light breakfast on the morning of the procedure. For diagnosis and localization of myocardial ischaemia (using planar or SPECT techniques) and assessment of left ventricular function using ECG-gated SPECT, the usual procedure involves two intravenous injections of tetrofosmin ( 99m Tc), one given at peak stress and one given at rest. The order of the two administrations can be either rest first and stress second or stress first and rest second. When rest and stress injections are administered Baca dokumen lengkap