Radiopharmaceuticals

The Hevesy Laboratory produces radioactive drugs for diagnosis and therapy. The drugs are primarily sold to hospitals and research institutions in Denmark and abroad.

Cyclotron

A GMP Unit ensures that the Hevesy Laboratory is a fully qualified/validated QC (Quality Control Laboratory) with a GMP (Good Manufacturing Practices) compliant organization.

Currently, 18F-Fludeoxyglucose is produced under a marketing permit and a number of other radiopharmaceuticals as part of a compassionate use programmes for diagnostic purposes.

 

[18F]Fludeoxyglucose for injection (Fludeoxyglucosi (18F) solutio iniectabilis): sterile and bacterial endotoxine-free solution of 2-[18F] fluoro-2-deoxy-D-glucopyranose (2-[18F] fluoro-2-deoxy-D-glucose) for diagnostic use. The solution contains 18F- fluoride isotope, minimum 95% of the radioactivity in the form of 2-[18F] fluoro-2-deoxy-D-glucose and 2-[18F] fluoro-2-deoxy-D-mannose, with the 2-[18F] fluoro-2-deoxy-D-mannose fraction not more than 10% of the total radioactivity (Ph.Eur.). Activity: 400MBq-90GBq.

The Fludeoxyglucose (FDG) is the widest used PET imaging agent in oncology, for the detection of primary tumors, differential diagnosis, and characterization of residual tumors after treatment as well as for monitoring of chemotherapy. It is also used for the PET assessment of glucose metabolism in the heart, lung and brain.
[18F]Fluorocholine. A fairly new PET imaging agent, which has shown very promising results in the evaluation of brain- and prostate- cancer patients. Activity: 400MBq-20GBq.
[18F]Sodium Fluoride for injection (Natrii Fluoridi (18F)solutio iniectabilis): sterile and bacterial endotoxine-free solution , for diagnostic use, containing 18F- fluoride isotope, minimum 98,5% of the total radioactivity, in the form of sodium fluoride (Ph.Eur.). Activity: 400 MBq-90 GBq.

The Sodium (18F) Fluoride was first introduced as a skeletal PET imaging agent by Blau M in 1962. It is used for the detection of bone lesions in various malignancies (metastasis) and was suggested as an alternative to 99mTc-methylene diphosphonate (99mTc-DMP) bone scintigraphy.
177Lu-DOTATATE. A radiolabeled somatostatin analogue used in peptide receptor radionuclide therapy of neuroendocrine tumors. Activity: 7,4GBq-25GBq.

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Lars Diernæs

Lars Diernæs Qualified Person (QP) Department of Health Technology