Land: Malta
Språk: engelska
Källa: Medicines Authority
FLUDEOXYGLUCOSE
Curium International Boulevard Bischoffsheim 39 boîte 4 1000 Bruxelles , Belgium
V09IX04
FLUDEOXYGLUCOSE 185 MBq/ml
SOLUTION FOR INJECTION
FLUDEOXYGLUCOSE 185 MBq/ml
POM
DIAGNOSTIC RADIOPHARMACEUTICALS
Authorised
2019-01-18
P7044p 12/2023 1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT FLUDEOXYGLUCOSE ( 18 F)-CURIUM 185 MBQ/ML SOLUTION FOR INJECTION Fludeoxyglucose ( 18 F) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU WILL BE ADMINISTERED THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your nuclear medicine doctor who will supervise the procedure. - If you get any side effects, talk to your nuclear medicine doctor. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Fludeoxyglucose ( 18 F)-Curium is and what it is used for 2. What you need to know before Fludeoxyglucose ( 18 F)-Curium is used 3. How Fludeoxyglucose ( 18 F)-Curium will be used 4. Possible side effects 5 How Fludeoxyglucose ( 18 F)-Curium is stored 6. Contents of the pack and other information 1. WHAT FLUDEOXYGLUCOSE ( 18 F) - CURIUM IS AND WHAT IT IS USED FOR This medicine is a radiopharmaceutical product for diagnostic use only. The active substance contained in Fludeoxyglucose ( 18 F)-Curium is designed for the capture of diagnostic images of some parts of your body. Once a small amount of Fludeoxyglucose ( 18 F)-Curium has been injected, medical images that are obtained with a special camera will enable the doctor to capture images and to see where your illness is or how it is progressing. 2. WHAT YOU NEED TO KNOW BEFORE FLUDEOXYGLUCOSE ( 18 F)-CURIUM IS USED FLUDEOXYGLUCOSE ( 18 F)-CURIUM MUST NOT BE USED: - If you are allergic to fludeoxyglucose ( 18 F) or any of the other ingredients of this medicine (listed in section 6). P7044p 12/2023 2 WARNINGS AND PRECAUTIONS Talk to your nuclear medicine doctor before being administered Fludeoxyglucose ( 18 F)-Curium: - If you are diabetic and your diabetes is currently not equilibrated, - If you have an infection or ,an inflammatory disease, - If you are affected by kidney problems. Inform your nuclear medicine doctor in the following cases: - If you Läs hela dokumentet
1 P7044n 12/2023 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Fludeoxyglucose ( 18 F)-Curium 185 MBq/mL solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL contains 185 MBq of fludeoxyglucose ( 18 F) at the date and time of calibration. The activity per vial ranges from 90 MBq to 1850 MBq at the date and time of calibration. Fluorine ( 18 F) decays to stable oxygen ( 18 O) with a half-life of 110 minutes by emitting a positronic radiation of maximum energy of 634 keV, followed by photonic annihilation radiations of 511 keV. Excipients with known effects: Each mL of fludeoxyglucose ( 18 F) contains 9 mg of sodium chloride and less than 4 mg of ethanol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Clear, colourless or slightly yellow solution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Fludeoxyglucose ( 18 F) is indicated for use with positron emission tomography (PET) in adults and paediatric population. _Oncology _ 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 (see also section 4.4): _ _ Diagnosis: • Characterisation of solitary pulmonary nodules • 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 2 P7044n 12/2023 Detection in case of reasonable su Läs hela dokumentet