Negara: Norwegia
Bahasa: Norwegia
Sumber: Statens legemiddelverk
Fludeoksyglukose (18F)
GE Healthcare B.V.
V09IX04
Fludeoksyglukose (18F)
250 MBq/ ml
Injeksjonsvæske, oppløsning
Hetteglass 12000 MBq
C
Markedsført
2006-02-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Steripet 250 MBq/ml Solution for injection 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains 250 MBq fludeoxyglucose ( 18 F) at the date and time of calibration. The activity per vial ranges from 250 MBq_ _to 2.5 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. Excipient with known effect: 5.19 mg/ml sodium. 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 nodule Detection of cancer of unknown origin, revealed for example by cervical adenopathy, liver or bone 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 wit Baca dokumen lengkapnya