Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
FLUDEOXYGLUCOSE (18F)
M2i Limited
FLUDEOXYGLUCOSE (18F)
1-13 GBq/ml
Solution for Injection
Product subject to Restricted Prescription (C)
Authorised
0000-00-00
FLUDEOXYGLUCOSE ( 18 F) INJECTION, ERIGAL. PACKAGE LEAFLET: INFORMATION FOR THE PATIENT READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE ADMINISTERED THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your referring doctor or the specialist physician in Nuclear Medicine who will supervise the procedure. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your referring doctor or the specialist physician in Nuclear Medicine who has supervised the procedure. IN THIS LEAFLET: 1. What Fludeoxyglucose Erigal* is and what it is used for. 2. Before Fludeoxyglucose Erigal is administered. 3. How Fludeoxyglucose Erigal will be used. 4. Possible side effects. 5. How to store Fludeoxyglucose Erigal. 6. Further information. 1. WHAT FLUDEOXYGLUCOSE ERIGAL IS AND WHAT IT IS USED FOR. WHAT FLUDEOXYGLUCOSE ERIGAL IS: Fludeoxyglucose Erigal is a type of medicine called a diagnostic radiopharmaceutical medicine. It is used to help identify (diagnose) and pinpoint (localise) the illness you may have. WHAT FLUDEOXYGLUCOSE ERIGAL IS USED FOR: Fludeoxyglucose Erigal is used to help diagnose and locate certain types of medical illnesses, including brain problems, heart problems, cancer, infections and inflammatory illnesses. Fludeoxyglucose Erigal consists of a sugar called deoxyglucose that is attached to a tiny amount of a radioactive substance, known as Fluorine‐18, to form a substance called Fludeoxyglucose 18F. Your body contains millions of living cells. All the cells use sugar (glucose) for energy. When you have certain medical conditions, some parts of your body will use more glucose than n Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ERtracER Fludeoxyglucose ( 18 F) Injection, Solution for Injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 110 – 10,000 MBq fludeoxyglucose ( 18 F) at the date and time of calibration. The activity per vial ranges from 110 MBq to 50,000 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 positronic radiation of maximum energy of 634 keV, followed by photonic annihilation radiations of 511 keV. For a 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 medical product is for diagnostic use only. Fludeoxyglucose ( 18 F) is indicated for use with positron emission tomography (PET) 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 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 : IRISH MEDICINES BOARD ______________________________________________________________________________________________ Läs hela dokumentet