Steripet 250 MBq/ ml

Country: Norveġja

Lingwa: Norveġiż

Sors: Statens legemiddelverk

Ingredjent attiv:

Fludeoksyglukose (18F)

Disponibbli minn:

GE Healthcare B.V.

Kodiċi ATC:

V09IX04

INN (Isem Internazzjonali):

Fludeoksyglukose (18F)

Dożaġġ:

250 MBq/ ml

Għamla farmaċewtika:

Injeksjonsvæske, oppløsning

Unitajiet fil-pakkett:

Hetteglass 12000 MBq

Tip ta 'preskrizzjoni:

C

L-istatus ta 'awtorizzazzjoni:

Markedsført

Data ta 'l-awtorizzazzjoni:

2006-02-20

Karatteristiċi tal-prodott

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