Commercial Production of Radiopharmaceuticals

Fludeoxyglucosa 

Name of product: Fludeoxyglucosa 

Manufacturer and holder of the registration decision: ÚJV Řež, a. s., Hlavní 130, 250 68 Husinec-Řež, Czech Republic

Indication group: radiopharmaceuticals – radionuclide diagnostic agent

Registration No.: 88/320/01-C

Medicinal substance: Fludeoxyglucosum (18F) 100 - 1500 MBq / ml
Indication: localization of primary tumors and metastases of most malignant neoplasms, evaluation of biological behavior of tumors, assessment of the extent of tumorous diseases, evaluation of the efficiency of antitumor treatment, a prognostic estimate of diseases, detection of disease recurrence, location of the area in which the epileptogenic zone is present, the examination of regional utilization of glucose in the brains of patients with neurologic disorders, diagnosis of degenerative brain damage,
diagnosis of inflammations, localization of the cause of febrile events, assessment of myocardial viability.

Manner of administration: single application of Fludeoxyglucosa in intravenous injection.

Applicability: 8 hours from calibration date and hour.

Storing: in temperature up to 25°C

–  Inner container: injection vial (10 ml or 20 ml) from the glass of the 1st hydrolytic class, closed with a rubber stopper and a metal overseal.

–  Outer container: lead container

Package sizes: 0,5; 1; 1,25; 1,5; 1,75; 2; 2,5; 3; 3,5; 4; 4,5; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 11; 12; 13; 14; 15; 16; 17; 18; 19; 20; 21; 22; 23; 24; 25; 26; 27; 28; 29; 30 GBq in injection vial for a repeated administration.

Fludeoxyglucose (18F) UJV

Name of product: Fludeoxyglucose (18F) UJV

Manufacturer and holder of the registration decision: ÚJV Řež, a. s., Hlavní 130, Řež, 250 68 Husinec, Czech Republic

Indication group: radiopharmaceuticals – radionuclide diagnostic agent.

Registration No.: 88/418/16-C

Medicinal substance: 1 ml contains Fludeoxyglucosum (18F) 100 - 1500 MBq to calibration date and time. The activity in the bottle ranges from 500 MBq to 30 000 MBq to calibration date and time.

Indication: This agent is intended only for diagnostic purposes. Fludeoxyglucose (18F) is used in connection with positron emission tomography (PET) in adults and in the pediatric population.

– Oncology – diagnosis – characterization of the solitary pulmonary node, detection of tumors of unknown origin with symptoms e.g. cervical adenopathy, hepatic or bone metastases, characterization of formations on the pancreas, identification of the stage – tumors in the area of the head and throat, including biopsy assistance, primary lung cancer, locally advanced breast cancer, esophagus cancer, pancreatic cancer, colorectal tumor especially in recurrence restaging, malignant melanoma, Breslow
>1,5 mm or metastasis into lymphatic nodes during the first diagnosis, observing the therapeutic response – malignant lymphoma, tumors in the area of the head and throat, detection if there are reasonable grounds of recurrence.

– Cardiology – assessment myocarditis viability in patients with serious disorders of the function of the left chamber who are supposed to undergo revascularisation if conventional imaging procedures fail.

– Neurology – localization of epileptogenic foci in the pre-operation assessment of partial temporal epilepsy. Infectious or inflammatory diseases, localization of abnormal centers in etiologic diagnoses with fevers of unknown origin, infection diagnosis, detecting the spread of inflammation, therapy observation.

Manner of administration: single application of the product in intravenous injection.

Applicability: 12 hours after production is completed.

Storing: This product has no special requirements for storage temperature.

– Inner container: glass injection vial (10 ml or 20 ml) for repeated the administration closed with a dark grey bromobutyl rubber stopper, an aluminum overseal and a sterile plastic cap.

– Outer container: lead container of the type P30, HU GP-40 container, or other container types approved for transporting radioactive substances.

Package sizes: 0,5; 1; 1,25; 1,5; 1,75; 2; 2,5; 3; 3,5; 4; 4,5; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 11; 12; 13; 14; 15; 16; 17; 18; 19; 20; 21; 22; 23; 24; 25; 26; 27; 28; 29; 30 GBq in injection vial for repeated administration.

Sodium Fluoride (18F) UJV

Name of product: Fluorid (18F) sodný UJV

Manufacturer and holder of the registration decision: ÚJV Řež, a. s., Hlavní 130, Řež, 250 68 Husinec, Czech Republic.

Indication group: radiopharmaceuticals – radionuclide diagnostic agent.

Registration No.: 88/394/16-C

Medicinal substance: 1 ml of the injection solution contains sodium fluoride (18F) 100 – 1500 MBq to calibration date and time. The activity in the bottle ranges from 0.5 to 30 GBq to calibration date and time.

Indication: This product is intended for diagnostic purposes only - detecting and localizing bone metastases in cancer diseases in adults and children, further as assistance in evaluating back pain of unknown origin in adults if results of conventional imaging methods are ambiguous and in detecting the presence of bone lesions in children if there is a suspicion of misuse.

Manner of administration: single application of the product in intravenous injection.

Applicability: 10 hours after production is completed.

Storing: This product has no special requirements for storage temperature.

– Inner container: injection vial (10 ml or 20 ml) for repeated administration, from a glass of 1st hydrolytic class closed with a rubber stopper and a metal overseal.

– Outer container: lead container of the type P30, HU GP-40 container, or other container types approved for transporting radioactive substances.

Package sizes: 0,5; 1; 1,25; 1,5; 1,75; 2; 2,5; 3; 3,5; 4; 4,5; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 11; 12; 13; 14; 15; 16; 17; 18; 19; 20; 21; 22; 23; 24; 25; 26; 27; 28; 29; 30 GBq in injection vial for repeated sampling.

Fluorocholine (18F)

Name of product:  Fluorocholine (18F) UJV 100-3000 MBq/ml solution for injection

Manufacturer and holder of the registration decision: ÚJV Řež, a. s., Hlavní 130, Řež, 250 68 Husinec, Czech Republic.

Indication group: radiopharmaceuticals – radionuclide diagnostic agent.

Registration No.: 88/001/18-C

Medicinal substance: 1 ml solution for injection contains 100 - 3000 MBq/ml N - ([18F]fluoromethyl)-2-hydroxy-N,N-dimethylethan-1-aminium (fluorocholine (18F)) to calibration date and time.The activity in the bottle ranges from 500 MBq to 30 000 MBq to calibration date and time.

Indication: Fluorocholine (18F) UJV is a diagnostic radiopharmaceutical intended for the positron emission tomography (PET) method in adults in the following indications:

– Prostate carcinoma
 – the initial staging of prostate cancer in medium and high-risk patients,  – localization of recurrence and metastases of prostate cancer.

– Localization of adenoma or parathyroid hyperplasia when primary hyperparathyroidism is suspected.

– Hepatocellular carcinoma
 – localization of lesions of well-differentiated hepatocellular carcinoma,
 – in addition to PET with FDG, liver nod characterization, and/or staging of proven or highly probable hepatocellular carcinoma, if   PET with FDG does not provide sufficient evidence or if surgical treatment or transplantation is planned.

Manner of administration: single application of the product in intravenous injection.

Applicability: 12 hours after production is completed.

Storing: The product must be stored in sealed containers in accordance with the regulations on the protection of health against ionizing radiation. Do not freeze.

– Inner container: injection vial 10 ml from the glass of the 1st hydrolytic class, closed with a rubber stopper and an aluminum overseal.

– Outer container: lead, tungsten, or uranium container.

Package sizes: 0,5; 1; 1,25; 1,5; 1,75; 2; 2,5; 3; 3,5; 4; 4,5; 5; 5,5; 6; 6,5; 7; 7,5; 8; 8,5; 9; 9,5; 10; 11; 12; 13; 14; 15; 16; 17; 18; 19; 20; 21; 22; 23; 24; 25; 26; 27; 28; 29; 30 GBq in injection vial for repeated sampling.

• For the needs of distribution, transport, and sale of medicinal products within the Czech Republic, we hold a certificate of good distribution practice as well as the necessary licences for ionising radiation management, and our monitored vehicles are subject to the rules of the ADR (European Agreement concerning the International Carriage of Dangerous Goods by Road - Accord Dangereuses Route)
• Performing activities of Qualified Person (QP)
  • We have a sufficient number of experienced and qualified persons with high levels of expertise and education and who are able to ensure the release of the medicinal products for sale even via remote access

The defined and set chemical and physical control processes in the GMP mode cover areas of PET radiopharmaceuticals as well as other pharmaceutical raw substances and materials. Quality control with appropriate instrumentation includes

:

• Input raw materials
• Intermediate products
• Medicinal products
• Microbiological control
• Monitoring stability
• Validation of analytical methods

• We are holders of all necessary permits and certificates
• We have adequate spatial and technological facilities and experienced highly educated staff.

Address: ÚJV Řež, a. s., Hlavní 130, 250 68 Husinec - Řež

• The PET Center serves primarily for the R&D of new radiopharmaceuticals with ultra-short-living PET radionuclides.
• This project was awarded third place in the category of “Investor of 2010”.
  The prize for the highest innovation potential was awarded by CzechInvest in cooperation with the Ministry of Industry and Trade and the Association for Foreign Investment. The project was co-financed from the European Regional Development Fund (ERDF) and from the national budget of the Czech Republic under the POTENTIAL programme. The construction of a third floor of the R&D PET Centre Řež followed which, in cooperation with the health facility, plays a development-manufacturing-application role. The implementation of the second phase of the PET centre was supported by the European Regional Development Fund (ERDF) and the national budget of the Czech Republic under the OPPI programme (Operational Programme Enterprise and Innovation – Ministry of Industry and Trade), the Training Centre programme

Address:Nemocnice Na Homolce, Roentgenova 2,  č.p. 37, 150 30 Praha 5

• This is the first PET centre in the Czech Republic and was built in cooperation with the International Atomic Energy Agency (IAEA). IAEA approved the plan as a model project and pledged financial support. Through this cooperation, the construction of the first PET centre in the Czech Republic on the premises of the Na Homolce Hospital in Prague was commenced in November 1998. The PET Centre Prague was inaugurated in August 1999, and it was here that the first patient in the Czech Republic was examined using the PET method.
• The facility is equipped to manufacture the most commonly used PET radiopharmaceutical “Fludeoxyglukosa inj.” (commercial name of the product of ÚJV Řež, a. s.). This is a radiodiagnostics agent used by PET or PET/CT methods.

Address: Masarykův onkologický ústav, Žlutý kopec 7a, 656 53 Brno

• In order to make the Moravian regions independent of supplies of PET radiopharmaceuticals from Central Bohemia, a second PET centre was built within the Masaryk Memorial Cancer Institute in Brno in 2005. The construction started in April 2006. This construction was partially funded as part of the INOVACE II programme of the European Regional Development Fund (ERDF) as well as from the national budget of the Czech Republic. The PET Centre Brno commenced trial operation on 1 June 2007.
• The facility is equipped to manufacture the most commonly used PET radiopharmaceutical “Fludeoxyglukosa inj.” (commercial name of the product of ÚJV Řež, a. s.). This is a radiodiagnostics agent used by PET or PET/CT methods.