Products

[18F] PET radiopharmaceuticals

• labelled with the most widely used PET radionuclide 18F with a half-life of 109.8 min and a maximum positron energy of 633 keV
• they are carrier-free, sterile and non-pyrogenic radiodiagnostic agents
• intravenous administration

2-[18F]-FDG

• the most widely used PET radiopharmaceutical for imaging lesions with intensive glucose metabolism
• used in particular for imaging increased glucose consumption in the brain, heart and tumour lesions (diagnosis, staging and monitoring of cancer therapy)

Summary of Product Characteristics

Package leaflet

Sodium Fluoride (18F) RadioMedic

• a preparation for the topographic analysis of regional changes in the skeleton and for in vivo determination of overall metabolic turnover in the skeletal system (primary and secondary malignant bone tumours and joint diseases)

Summary of Product Characteristics

Package leaflet

Fludeoxythymidine (18F) RadioMedic

• a preparation for the diagnosis of rapidly proliferating tumour tissue, especially in the brain and lungs

Summary of Product Characteristics

Package leaflet

Radionuclide generator 81Rb/81mKr

Marketing Authorization in the Czech Republic

• the half-life of the active substance 81mKr is 13.1 s, with emission of a gamma quantum of energy 190.4 keV
• a radiopharmaceutical for lung ventilation examinations (pulmonary embolism, chronic obstructive pulmonary disease, chronic bronchitis, asthma and bronchogenic carcinoma)
• reliable imaging of the actual state of lung ventilation thanks to the elimination of false-negative findings (passive lung ventilation)
• exceptionally low radiation burden for the patient and absence of radioactive waste
• the difference in the energy of the emitted gamma quanta of 81mKr (190.4 keV) and 99mTc (140.5 keV) allows parallel examination of lung ventilation and perfusion, which is the best available diagnostic tool for pulmonary embolism

Summary of Product Characteristics

Package leaflet

Radionuclide generator 81Rb/81mKr

Marketing Authorization in the Slovak Republic

Summary of Product Characteristics

Package leaflet

18F-FES

• solution for injection
• an intravenous PET diagnostic agent containing 18F with a half-life of 109.8 min, a max. positron energy of 633 keV and subsequent annihilation gamma radiation of energy 511 keV
• the active substance fluoroestradiol (18F) is used for the in vivo determination of the level of expression and binding properties of oestrogen receptors (ER) in breast carcinoma:
  • for the staging and restaging of ER-positive breast carcinoma
  • to predict a patient's response to endocrine treatment
  • to determine the heterogeneity of oestrogen-receptor expression in the primary tumour and its metastases
• it makes it possible to visualise and locate tumours expressing oestrogen receptors throughout the body without the need for a biopsy
• given the possible heterogeneity of tumours, a significant advantage of PET imaging is the determination of the level of oestrogen-receptor expression across the entire tumour volume and the evaluation of the biological activity of the receptors in tumour diagnosis and treatment response
• the recommended administered activity for adults is 140–280 MBq, on average 220 MBq for a 70 kg patient
• patient imaging is performed 60–80 min after administration for a period of 20–30 min

Files to download:

Information for healthcare professionals

Information for patients

18F-FMISO

Files to download:

Summary of Product Characteristics

Package leaflet

Research and development of radiopharmaceutical preparations focuses exclusively on the synthesis of compounds intended for PET diagnostics. These are compounds labelled with the positron-emitting radionuclide ¹⁸F. In the field of compounds suitable for SPECT diagnostics, research and development has focused on compounds labelled with the radionuclide ¹²³I.

[¹⁸F] PET radiopharmaceuticals

[¹⁸F]FET (O-(2-[¹⁸F]fluoroethyl)-L-tyrosine)

• a PET diagnostic agent for the diagnosis of brain tumours
• compared with the routinely used 2-[¹⁸F]-FDG, the ratio of radiopharmaceutical concentration in the tumour versus healthy tissue is higher

---

[¹⁸F]FCH ([¹⁸F]fluoromethylcholine)

• a preparation for imaging primary and recurrent prostate carcinoma
• development of the production technology and validation of quality-control methods completed; preclinical evaluation finished

---

[¹⁸F]F-PSMA

• a preparation for imaging primary and recurrent prostate carcinoma
• technologies for future manufacture of the medicinal product are currently under development
• highly selective for tumour tissue; it does not accumulate in inflammatory or necrotic tissue

---

[¹⁸F]FFMZ (2′-[¹⁸F]fluoroflumazenil)

• primarily a PET diagnostic agent for Alzheimer's disease and neurodegenerative brain disorders. It images GABA(A)/benzodiazepine receptors and is therefore a suitable tool for localising temporal lobe epilepsy and for imaging pulmonary ischaemia and monitoring chemotherapeutic treatment
• compared with other methods such as magnetic resonance imaging, PET imaging with [¹⁸F]FDG and SPECT brain perfusion with [¹²³I]IMZ, this radiopharmaceutical is by far the most conclusive