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The information on this site is intended for healthcare professionals (pursuant to Section 2a of Act No. 40/1995 Coll.)
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.
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.
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.
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.
