Quest for the right Drug
מיוויו MYOVIEW (TETROFOSMIN)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
תוך-ורידי : I.V
צורת מינון:
אבקה מיובשת בהקפאה להכנת תמיסה להזרקה : LYOPHILIZED POWDER FOR SOLUTION FOR INJECTION
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Posology : מינונים
4.2 Posology and method of administration Posology Paediatric population Myoview is not recommended for use in children or adolescents as data are not available for these age groups. Adults Myocardial Imaging 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), 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 on the same day, the activity administered for the second dose should result in a myocardial count rate at least three times greater than that of the residual activity from the first dose. The recommended activity range for the first dose is 250-400 MBq; the recommended activity range for the second dose given at least 1 hour later, is 600-800 MBq. When rest and stress injections are administered on different days, the recommended activity range for each dose of tetrofosmin (99m Tc) is 400-600 MBq. For studies on larger individuals (e.g. those with abdominal obesity or women with large breasts) use of activities at the higher end of this range is warranted. The total activity administered for stress and rest myocardial imaging studies, whether performed on one or two days, should be restricted to 1200 MBq. As an adjunct in the diagnosis and localization of myocardial infarction, one injection of tetrofosmin (99m Tc) (250-400 MBq) at rest is sufficient. Planar or preferably SPECT imaging should begin no earlier than 15 minutes post-injection. There is no evidence for significant changes in myocardial concentration or redistribution of tetrofosmin (99m Tc), therefore, images may be acquired up to at least four hours post injection. For planar imaging the standard views (anterior, LAO 40º-45º, LAO 65º-70º and/or left lateral) should be acquired. Breast Imaging For the diagnosis and localization of suspected breast lesions, the recommended procedure involves a single intravenous injection of tetrofosmin (99m Tc) between 500– 750 MBq. The injection should preferably be given in a foot vein or a site other than the arm on the side of the suspected breast lesion. The patient does not need to fast before the injection. Breast imaging optimally initiated 5 – 10 minutes post injection with the patient in the prone position with the breast(s) freely pendant. A special imaging couch designed for nuclear medicine breast imaging is recommended. A lateral image of the breast suspected of containing lesions should be obtained with the camera face as close to the breast as is practicable. The patient should then be repositioned so that a lateral image of the pendant contralateral breast can be obtained. An anterior supine image may then be obtained with the patient’s arms behind her head. Method of administration This medicinal product should be reconstituted before administration to the patient. For instructions on reconstitution of the medicinal product before administration, see section 11. For patient preparation, see section 4.4
שימוש לפי פנקס קופ''ח כללית 1994
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תאריך הכללה מקורי בסל
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הגבלות
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מידע נוסף