Qualitative and quantitative composition:One vial contains:
Active ingredients: sodium pyrophosphate decahydrate 13.40 mg
Excipient: stannous (II) chloride dihydrate 4.3 mg
The radionuclide is not part of the kit.
Pharmaceutical form:Lyophilisate for solution for injection.
White powder.
Therapeutic indicationsThis medicinal product is for diagnostic use only.
This medicinal product is indicated for:
– In vivo, in vitro or in vivo/in vitro red blood cell labelling for blood pool scintigraphy used for:
– angiocardioscintigraphy for:
● evaluation of ventricular ejection fraction,
● evaluation of global and regional cardiac wall motion,
● phase analysis of myocardial contractility.
– organ perfusion and vascular abnormalities imaging.
– diagnosis and localization of occult gastrointestinal bleeding.
– Determination of blood volume.
– Spleen scintigraphy.
Shelf life:Shelf life of the kit is 1 year.
After reconstitution with normal saline, the product should be used within 3 hours, if stored below 25°C.
Special precautions for storage:Store in a refrigerator (2°C – 8°C).
During transportation (no longer than 7 days) up to 35°C is permitted.
For storage conditions after reconstitution of the medicinal product, see section 6.3 of SmPC.
Storage of radiopharmaceuticals should be in accordance with national regulations on radioactive materials.
Nature and contents of container:10 mL glass vial, sealed with rubber stopper and an aluminium crimp cap. Vials are packed in cardboard boxes. Pack sizes of 3 or 6 vials are available. Not all pack sizes may be marketed.
EnclosureSmPC – PoltechRBC, 13,40 mg