|Qualitative and quantitative composition:||1 vial contains:|
Active substance [Tetrakis(2-methoxy-2-methylpropyl-1-isocyanide) copper(1+)]tetrafluoroborate 1.00 mg
The radionuclide is not part of the kit.
For a full list of excipients, see section 6.1. of SmPC.
|Pharmaceutical form:||Kit for radiopharmaceutical preparation.|
|Therapeutic indications:||This medicinal product is for diagnostic use only.|
For intravenous injection after radiolabelling with sodium (Tc-99m) pertechnetate solution. PoltechMIBI using scintigraphy is indicated for:
– diagnosis of ischaemic heart disease.
– diagnosis and localisation of myocardial infarction.
– assessment of global ventricular function (first pass technique for determination of ejection fraction and/or regional wall motion).
– diagnosis of malignancy in patients who are suspected of cancer in the breast combined with inconclusive mammography or palpable tumour and negative or inconclusive mammography.
– diagnosis of patients with recurrent or persistent hyperparathyroidism.
|Shelf life:||Kit – 1 year.|
After radiolabelling with sodium pertechnetate (99mTc) solution: 8 hours. Store below 25°C in a suitable radiation lead shield.
|Special precautions for storage:||Store in a refrigerator (2°C- 8°C).|
During transportation (not longer than 7 days) up to 35°C. For storage conditions after reconstitution of the medicinal product, see section 6.3. of SmPC.
Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials.
|Nature and contents of container:||10 ml glass vials, type I glass (Ph. Eur.) sealed with rubber stopper and an aluminium crimp cap.Vials are packed in cardboard boxes and pack size of 3 or 6 vials are available.|
Not all pack sizes may be marketed
|Enclosure||SmPC – PoltechMIBI, 1 mg|