|Qualitative and quantitative composition:||1 vial contains:|
methylenediphosphonic acid 5 mg
as sodium methylenediphosphonate 6.25 mg.
The radionuclide is not part of the kit.
For the full list of excipients, see SmPC.
|Pharmaceutical form:||Kit for radiopharmaceutical preparation.|
Lyophilisate for solution for injection.
|Therapeutic indications:||This medicinal product is for diagnostic use only.|
The radiopharmaceutical 99mTc-MDP is intended for skeletal imaging utilizing radioactive properties of technetium-99m and the affinity of methylenediphosphonic acid to hydroxyapatite crystals which form inorganic structure of bone tissue.
|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 radiolabelling of the medicinal product, see section 6.3 of SmPC.
|Indications:||The radiopharmaceutical 99mTc-MDP is intended for skeletal imaging utilizing radioactive properties of technetium-99m and the affinity of methylenediphosphonic acid to hydroxyapatite crystals which form inorganic structure of bone tissue.|
Indications for scintigraphic examinations using 99mTc-MDP are as follows:
● detection of metastatic foci in skeletal system;
● imaging of altered bone metabolism in primary bone tumors;
● imaging of bone inflammation;
● imaging of post-traumatic lesions;
● imaging of rheumatoid lesions;
● imaging of aseptic necrosis;
● diagnosis of soft tissue diseases, eg. myositis ossificans;
● examination of repair processes in damaged bone tissue.
Use of the radiopharmaceutical for the aforementioned purposes enables precise localization and assessment of lesions extent.
|Enclosure||SmPC – PoltechMDP, 5 mg|