Product

EFDEGE – 1.0 GBq/mL, Solution for injection

fig. 1. fdg 1 wide

Marketing Authorizations

Country
Product Name
MA number
Date of registration
PDF
PDF
France
EFDEGÉ
564 456-4 (11ml)/ 490 133-2 (25ml)
15.12.2003
Austria
EFDEGE
4-00020
15.05.2004
Belgium
EFDEGÉ
BE 285424
21.06.2004
No data was found
No data was found
No data was found
No data was found
Croatia
EFDEGE
HR-H-199234710
18.12.2009
Czech Republic
EFDEGE
88/328/05-C
19.10.2005
No data was found
No data was found
Germany
EFDEGE
59726.00.00
21.06.2004
Greece
EFDEGE
68514/2-12-2004
31.12.2004
Hungary
EFDEGE
OGYI-T-10441/01 (11ml) OGYI-T-10441/02 (11ml)
15.12.2005
Italy
EFDEGE
036751016 (11ml)/ 036751028 (25ml)
27.12.2005
No data was found
Luxemburg
EFDEGÉ
1523/04070003
30.07.2004
Malta
EFDEGE
MA986/00201 (11mL) MA986/00202 (25mL)
11.02.2021
Netherlands
EFDEGE
RVG 30417
03.02.2005
Poland
EFDEGE
12105
15.02.2006
Portugal
EFDEGE
5628383
28.10.2005
No data was found
No data was found
Slowenia
EFDEGE
H/05/00528/001 (11ml) H/05/00528/002 (11ml)
12.12.2005

Product sheets

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EFDEGE

Efdege (18F fludeoxyglucose) is an innovative radiopharmaceutical product that has been developed especially for use in positron-emission-tomography (PET) - one of the most advanced imaging techniques in nuclear medicine.

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.

This medicinal product is for diagnostic use only. 

Therapeutic indications. This medicinal product is for diagnostic use only.

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