Qualitative and quantitative composition:Vial I contains 20 micrograms of
HYNIC-[D-Phe1,Tyr3-Octreotide] trifluoroacetate.
The radionuclide is not part of the kit.
Pharmaceutical form: Kit for radiopharmaceutical preparation
White or almost white lyophilisates
For radiolabelling with sodium pertechnetate (99mTc) solution.
Therapeutic indications:This medicinal product is for diagnostic use only.
After radiolabelling with sodium pertechnetate (99mTc) solution, the solution of 99mTc-Tektrotyd obtained is indicated for use in adults as adjunct in the diagnosis and management of somatostatin receptor bearing neuroendocrine tumours (NET), by aiding their localization.
Tumours which do not bear somatostatin receptors will not be visualised (see section 4.4, „image interpretation” of SmPC).
Shelf life: 1 year.
After reconstitution and radiolabelling 4 hours when stored below 25°C.
Special precautions for storage:Store in a refrigerator at 2°C – 8°C. During transportation (not longer than 5 days) up to 35°C.
For storage conditions after radiolabelling 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:Glass vials (Type I Ph. Eur.) of 10 mL nominal capacity, sealed with a bromobutyl stopper and an aluminium cap.
EnclosureSmPC – Tektrotyd-20-micrograms