Zusammenfassung der Merkmale des Arzneimittels - Fludeoxyglucose (18F) UJV
Public Summary of the Risk Management Plan according to Section 34 Sentence 1a sub-section 3 of the
Medicinal Products Act(2)
Administrative Information:
| Wirkstoff | Fludeoxyglucose ((18)F) |
| ATC-Code | V09IX04 |
| Darreichungsform | Injektionslösung |
| Art der Anwendung | intravenöse Anwendung |
| Inhaber der Zulassung | UJV Rez, a.s. Hlavni 130 250 68 REZ, HUSINEC Tschechische Republik |
| Zulassungsnummer | 92053.00.00 |
| Datum der Zulassung | 01.02.2017 |
| Verkaufsabgrenzung | verschreibungspflichtig |
| Version und Datum des Risikomanagement-Plans | 1.1 / 27.07.2015 |
| Datum der Genehmigung des RMPs | 01.07.2016 |
Der im Folgenden wiedergegebene Ausschnitt des Risikomanagement-Plans (RMP) des o. g. Arzneimittels ist eine Zusammenfassung der wesentlichen Inhalte des RMP. Der RMP beschreibt die zu ergreifenden Maßnahmen zur Arzneimittelsicherheit, die Aktivitäten im Risikomanagement und in der Risikoanalyse um sicherzustellen, dass dieses Arzneimittel so sicher wie möglich angewendet wird.
Weitere Informationen zu RMP-Zusammenfassungen finden Sie hier (nur auf Englisch verfügbar).
Diese RMP-Zusammenfassung sollte in Verbindung mit der Zusammenfassung des öffentlichen Bewertungsberichts und der Produktinformation zu o. g. Arzneimittel gelesen werden, welche Sie auf der Produktseite auf PharmNet.Bund hier finden können.
Diese Zusammenfassung des RMPs wurde durch das Bundesinstitut für Arzneimittel und Medizinprodukte am 20. Mai 2019 veröffentlicht.
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PART VI: SUMMARY OF ACTIVITIES IN THE RISK MANAGEMENT PLAN BY PRODUCT
V I.1 Elements for summary tables in the EPAR
VI.1.1 Summary table of Safety concerns
| Summary of Safety Concerns | |
| Important identified risks | Hypersensitivity |
| Important potential risks | Use in pregnancy Nursing Mothers (lactation) Radiation Risks (cancerogenity, mutagenity) |
| Missing information | none |
V I.1.2 Table of on-going and planned studies in the Post-authorisation Pharmacovigilance Development Plan
No studies are planned.
V I.1.3 Summary of Post authorisation efficacy development plan
No studies are ongoing, no studies are planned.
V I.1.4 Summary table of Risk Minimisation Measures
| Safety Concern | Routine Risk Minimisation Measures | Additional Risk Minimisation Measures |
| Important identified risks | ||
| Hypersensitivity | Text in SmPC Section 4.3 Contraindications | None |
| Important potential risks | ||
| Use in pregnancy | Text in SmPC Section 4.6 Fertility, pregnancy and lactation Text in PL Section 2. Pregnancy and breast-feeding | None |
| Nursing Mothers (lactation) | Text in SmPC Section 4.6 Fertility, pregnancy and lactation Text in PL Section 2. Pregnancy and breast-feeding | None |
| Radiation Risks (cancerogenity, mutagenity) | Text in SmPC Section 4.8 Undesirable effects Text in PL Section 4. Possible side effects | None |
VI.2
Elements for a Public Summary
The preparation is only used for diagnostics.
In patients undergoing oncologic diagnostic procedures describing function or diseases where enhanced glucose influx of specific organs or tissues is the diagnostic target. The following indications are sufficiently documented: Diagnosis
- Characterisation of solitary pulmonary nodule, Detection of cancer of unknown origin, revealed for example by cervical adenopathy, liver or bones metastases, Characterisation of a pancreatic mass
Staging
- Head and neck cancers including assistance in guiding biopsy, Primary lung cancer, Locally advanced breast cancer, Oesophageal cancer, Carcinoma of the pancreas, Colorectal cancer particularly in restaging recurrences, Malignant lymphoma, Malignant melanoma, Breslow >1.5 mm or lymph node metastasis at first diagnosis Monitoring of therapeutic response
- Malignant lymphoma, Head and neck cancers
Detection in case of reasonable suspicion of recurrences
- Glioma with high grade of malignancy (III or IV), Head and neck cancers, Thyroid cancer (non-medullary): patients with increased thyroglobulin serum levels and negative radioactive iodine whole body scintigraphy, Primary lung cancer, Breast cancer, Carcinoma of the pancreas, Colorectal cancer, Ovarian cancer, Malignant lymphoma, Malignant melanoma
Cardiology
In the cardiologic indication, the diagnostic target is viable myocardial tissue that takes-up glucose but is hypo-perfused, as it must be assessed beforehand using appropriate bloodflow imaging techniques.
– Evaluation of myocardial viability in patients with severe impaired left ventricular function who are candidates for revascularisation when conventional imaging modalities are not contributive.
Neurology
In the neurologic indication the interictal glucose hypometabolism is the diagnostic target.
- Localisation of epileptogenic foci in the presurgical evaluation of partial temporal epilepsy
Infectious or inflammatory diseases
In infectious or inflammatory diseases, the diagnostic target is tissue or structures with an abnormal content of activated white blood cells.
In infectious or inflammatory diseases, the following indications are sufficiently
documented:
Localisation of abnormal foci guiding the aetiologic diagnosis in case of fever of unknown origin
Diagnosis of infection in case of:
Suspected chronic infection of bone and/or adjacent structures: osteomyelitis, spondilitis, diskitis or osteitis including when metallic implants are present, Diabetic patient with a foot suspicious of Charcot’s neuroarthropathy, osteomyelitis and/or soft tissue infection Painful hip prosthesis, Vascular prosthesis, ever in an AIDS patientDetection of the extension of inflammation in case of:
Sarcoidosis,Inflammatory bowel disease, Vasculitis involving the great vesselsThe preparation is only used for diagnostics.
Cancer is the second leading cause of death in the Czech Republic. Over than 27 thousand people die annually for cancer disease, which represents 23 % of total mortality. Cancer is also the second most important cause of morbidity of economically active part of the population. Annually 33 thousand cases of incapacity due to illness of cancer is recorded. The loss of national income spent on treatment, hospitalization, sickness benefits and disability pensions together cost 8.3 billion per annum. Causes of high mortality and economical losses are based both in the increasing incidence and in the later detection of cancer symptoms. The Czech Republic is the leader of EU statistics on the incidence of cancer in general and in the incidence of colon and rectum tumors in men. Breast cancer in women shows and increasing trend in the incidence and mortality is also high.
Positron emission tomography (PET) is one of the ways how to reveal cancer at early stage. PET is one of the nuclear medicine methods. PET displays different kinds of tissues depending on ability to absorb the radioactive substance. The PET examination is quick, nonivasive and can display the extend and also the activity of the disease. PET scans are combined with CT scans, so the physician obtains very specific information about the tumor location in the body. The test result and also the diagnosis is available immediately after the examination. The 97 % of all PET examinations are currently performed using the radiopharmaceutical preparation containing active compound fludeoxyglucosum (18F). It is kind of „gold standard“ for the diagnosis of oncological diseases. Glucosum is specific substance for cell metabolism, therefore the cancer cells consuming glucose can be displayed when fludeoxyglucosum (18F) is used.
None
V I.2.4 Summary of safety concerns
Important identified risks
| Risk | What is known | Preventability |
| Hypersensitivity | Hypersensitivity to active substance or to any of the excipients. | Avoidance of exposure for patients at increased risk |
Important potential risks
| Risk | What is known (Including reason why it is considered a potential risk) |
| Use in pregnancy Nursing mothers (lactation) Radiation Risks (cancerogenity, mutagenity) | Exposure to ionizing radiation is linked with cancer induction and a potential for development of hereditary defects. As the effective dose is 7.6 mSv when the maximal recommended activity of 400 MBq is administered these adverse reactions are expected to occur with a low probability. |
Missing information
There are no missing information.
This medicine has no additional risk minimisation measures.
This medicine do not require post authorisation development plan.