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.
White powder.
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
EnclosureSmPC – PoltechMIBI, 1 mg