Radiopharmaceuticals
GMP facility produces medicine for diagnostic & therapeutic applications.
The Radiopharmaceutical Section is a fully compliant Good Manufacturing Practice (GMP) facility that produces medicines for diagnostic and therapeutic applications for hospitals in Denmark and neighbouring countries. It also includes an authorization for IMPD (Investigational Medicinal Product Dossier).
Products in this category:
[18F]Fludeoxyglucose
[18F]Fludeoxyglucose ([18F]FDG) for injection: sterile and bacterial endotoxin-free solution of 2-[18F]fluoro-2-deoxy-D-glucopyranose (2-[18F]fluoro-2-deoxy-D-glucose). 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.). [18F]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]FDG is produced under a marketing permit issued by the Danish Medicines Agency.
Hevesy Laboratory has been producing [18F]FDG on a daily basis (Tuesday to Friday) for the past many years.
[18F]Flutemetamol
[18F]Flutemetamol ([18F]FLM) for injection: sterile and bacterial endotoxin-free solution of 2-[3-[18F]fluoro-4-(methylamino) phenyl]-6-benzothiazolol.
[18F]FLM is a molecular imaging agent that binds to β-amyloid aggregates and it is used for PET imaging of the brain i.e. Alzheimer’s diseases. This medicine is produced under the compassionate use permit issued by the Danish Medicines Agency.
Hevesy Laboratory has been producing [18F]FLM on a demand basis for the past years.
[64Cu]DOTATATE
[64Cu]DOTATATE (1,4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA)-octreotate) is an eight amino acid long peptide with a covalently bonded DOTA bifunctional chelator that is coupled to copper-64. [64Cu]DOTATATE is an excellent imaging agent for patients with neuroendocrine neoplasms (NENs).
Hevesy Laboratory has been producing a high specific [64Cu]DOTATATE twice a week for the past many years.