País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
Fludeoxyglucose [18F]
Curium Pharma Ireland Limited
V09IX; V09IX04
Fludeoxyglucose [18F]
110-10,000 megabecquerel(s)/millilitre
Solution for injection
Product subject to prescription which may not be renewed (A)
Other diagnostic radiopharmaceuticals for tumour detection; fludeoxyglucose (18F)
Marketed
2015-02-27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ERTRACER SOLUTION FOR INJECTION FLUDEOXYGLUCOSE ( 18 F) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE 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. WHAT IS IN THIS LEAFLET: 1. What ERtracER is and what it is used for. 2. What you need to know before ERtracER is administered. 3. How ERtracER is used. 4. Possible side effects. 5. How ERtracER is stored. 6. Contents of the pack and other information. 1. WHAT ERTRACER IS AND WHAT IT IS USED FOR. This medicine is a radiopharmaceutical product for diagnostic use only. The active substance contained in ERtracER is fludeoxyglucose ( 18 F) and is designed for the capture of diagnostic images of some parts of your body. Once a small amount of ERtracER has been injected, medical images that are obtained with a special camera will enable the doctor to capture images and see where your illness is or how it is progressing. 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 normal. Doctors use this change in the amount of glucose used to help identify and pinpoint the site of certain medical conditions. When ERtracER is given to you, a small amount of radioactive glucose spreads around your body and reaches the areas where glucose is being used the most. By using a special camera, known as a PET scanner or a gamma-camera, pictures (images) of the radiation coming from the ERtracER let your doctor ‘see’ where the radioactive glucose is being used the most. He/she can then use this to help identify (diagnose) and pinpoint sites where you have a particular medical condition Leer el documento completo
Health Products Regulatory Authority 13 March 2024 CRN00F6C3 Page 1 of 8 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ERtracER Solution for Injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 110 – 10,000 MBq fludeoxyglucose (18F) 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 (18F) decays to stable oxygen (18O) 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. Excipients with known effects: Each ml of fludeoxyglucose (18F) contains 5.5 mg of sodium chloride. Each ml of fludeoxyglucose (18F) contains up to 7.8 mg of ethanol. 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) in adults and the 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 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 Leer el documento completo