|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.|
|Therapeutic indications||This 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.|
|Enclosure||SmPC – PoltechRBC, 13,40 mg|