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EFDEGE®

Fludeoxyglucose [18F] solution injectabilis

Therapeutic indications

This medicinal product is for diagnostic use only.

Fludeoxyglucose (18F) 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
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 with increased thyroglobulin serum levels and negative radioactive iodine whole body scintigraphy
  • Primary lung cancer
  • Breast cancer
  • Carcinoma of the pancreas
  • Colorectal cancer
  • Ovarian cancer
  • Malignant lymphoma
  • Malignant melanoma
Cardiology

In the cardiologic indication, the diagnostic target is viable myocardial tissue that takes-up glucose but is hypo-perfused, as it must be assessed beforehand using appropriate blood-flow imaging techniques.

  • Evaluation of myocardial viability in patients with severe impaired left ventricular function who are candidates for revascularisation when conventional imaging modalities are not contributive.
Neurology

In the neurologic indication the interictal glucose hypometabolism is the diagnostic target.

  • Localisation of epileptogenic foci in the presurgical evaluation of partial temporal epilepsy.
Infectious or inflammatory diseases

In infectious or inflammatory diseases, the diagnostic target is tissue or structures with an abnormal content of activated white blood cells.

In infectious or inflammatory diseases, the following indications are sufficiently documented:

Localisation of abnormal foci guiding the aetiologic diagnosis in case of fever of unknown origin

Diagnosis of infection in case of:
  • Suspected chronic infection of bone and/or adjacent structures: osteomyelitis, spondilitis, diskitis or osteitis including when metallic implants are present
  • Diabetic patient with a foot suspicious of Charcot’s neuroarthropathy, osteomyelitis and/or soft tissue infection
  • Painful hip prosthesis
  • Vascular prosthesis
  • Fever in an AIDS Patient
  • Detection of septic metastatic foci in case of bacteraemia or endocarditis (see also section 4.4)
Detection of the extension of inflammation in case of:
  • Sarcoidosis
  • Inflammatory bowel disease
  • Vasculitis involving the great vessels
Therapy follow-up

Unresectable alveolar echinococcosis, in search for active localisations of the parasite during medical treatment and after treatment discontinuation.

CLINICAL PARTICULARS

Approvals

Country Product Approval number Date of registration PDF PDF
Austria Efdege 4-00020 25.05.2004 SPC PIL
Belgium fr EFDEGE BE 285424 21.06.2004 SPC PIL
Belgium de EFDEGE BE 285424 21.06.2004 SPC PIL
Belgium nl EFDEGE BE 285424 21.06.2004 SPC PIL
Germany EFDEGE 59726.00.00 21.06.2004 SPC PIL
France EFDEGE 564 456-4 (11ml) 15.12.2003 SPC PIL
France EFDEGE 490 133-2 (25ml) 15.12.2003 SPC PIL
Greece EFDEGE 68514/2-12-2004 31.12.2004 SPC PIL
Netherlands EFDEGE RVG 30417 03.02.2005 SPC PIL
Italy EFDEGE 036751016 (11ml) 27.12.2005 SPC PIL
Italy EFDEGE 036751028 (25ml) 27.12.2005 SPC PIL
Croatia EFDEGE HR-H-199234710 18.12.2009 SPC PIL
Luxembourg EFDEGE 1523/04070003 30.07.2004 SPC PIL
Luxembourg EFDEGE 1523/04070003 30.07.2004 SPC PIL
Poland EFDEGE 12105 15.02.2006 SPC PIL
Portugal EFDEGE 5628383 28.10.2005 SPC PIL
Slovenia EFDEGE H/05/00528/001 (11ml) 12.12.2005 SPC PIL
Slovenia EFDEGE H/05/00528/002 (25ml) 12.12.2005 SPC PIL
Czech Republic EFDEGE 88/328/05-C 19.10.2005 SPC PIL
Hungary EFDEGE OGYI-T-10441/01 (11ml) 15.12.2005 SPC PIL
Hungary EFDEGE OGYI-T-10441/02 (25ml) 15.12.2005 SPC PIL
english EFDEGE   15.12.2008 SPC PIL
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