Country: Malta
Tungumál: enska
Heimild: Medicines Authority
FLUDEOXYGLUCOSE
IASON GmbH Feldkirchner Str. 4, A-8054 Graz, Austria
V09IX04
FLUDEOXYGLUCOSE
SOLUTION FOR INJECTION
FLUDEOXYGLUCOSE 1 gigabecquerel/millilitre
POM
DIAGNOSTIC RADIOPHARMACEUTICALS
Licence number in the source country: NOT APPLICAPABLE
Authorised
2021-02-11
PAGE 1 OF 6 PACKAGE LEAFLET PAGE 2 OF 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EFDEGE 1.0 GBQ/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 any of the side effects, talk to your nuclear medicine. This includes any possible side effects not listed in this leaflet. WHAT IS IN THIS LEAFLET : 1. What EFDEGE is and what it is used for 2. What you need to know before EFDEGE is used 3. How EFDEGE is used 4. Possible side effects 5. How EFDEGE is stored 6. Contents of the pack and other information 1. WHAT EFDEGE IS AND WHAT IS USED FOR This medicine is a radiopharmaceutical product for diagnostic use only. The active substance contained in EFDEGE is fludeoxyglucose ( 18 F) and is designed for the capture of diagnostic images of some parts of your body. Once a small amount of EFDEGE 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 EFDEGE IS USED EFDEGE 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) WARNINGS AND PRECAUTIONS Talk to your nuclear medicine doctor before being administered EFDEGE: - if you are a 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 are pregnant or believe you may be pregnant - if you are breast-feeding PAGE 3 OF 6 BEFORE ADMINISTRATION OF EFDEGE YOU SHOULD: - drink plenty of water before the start of the examination in order to urinate as often as possible during the first hours after the Lestu allt skjalið
PAGE 1 OF 13 SUMMARY OF PRODUCT CHARACTERISTICS PAGE 2 OF 13 1. NAME OF THE MEDICINAL PRODUCT EFDEGE 1.0 GBq/mL, solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 mL solution for injection contains 1 GBq of fludeoxyglucose ( 18 F) at date and time of calibration. The activity per vial ranges from 0.2 GBq to 20.0 GBq 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 2.4 mg sodium. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. Clear and colourless or slight 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 PAGE 3 OF 13 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 I Lestu allt skjalið