ERTRACER, FLUDEOXYGLUCOSE (18F)
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
FLUDEOXYGLUCOSE (18F)
Available from:
M2i Limited
Dosage:
1-13 GBq/ml
Pharmaceutical form:
Solution for Injection
Authorization date:
2005-10-21
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ERtracER Fludeoxyglucose (
18
F) Injection, Solution for Injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains 110 – 10,000 MBq Fludeoxyglucose (
18
F) at the date and time of calibration.
The activity per vial ranges from 110 MBq to 50,000 MBq.
Fluorine-18 decays to stable oxygen-18 with a half-life of 109.77 minutes by emitting positronic radiation of maximum
energy of 634 keV, followed by photonic annihilation radiations of 500 keV.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for Injection.
Clear and colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medical product is for diagnostic use only.
Fludeoxyglucose (
18
F) is indicated for use with positron emission tomography (PET), either alone, or in conjuction
with other diagnostic modalities, in the diagnosis and/or investigation of the following conditions (see Table 1, and
section 4.4, Special warnings and special precautions for use):
ONCOLOGY
For imaging in patients undergoing oncologic diagnostic procedures describing function or diseases where enhanced
glucose influx of specific organs or tissues is the diagnostic target.
CARDIOLOGY
For evaluation of myocardial viability in patients with advanced coronary artery disease and/or severe impaired left
ventricular function who are candidates for revascularisation, when conventional imaging modalities are not
contributive.
NEUROLOGY
For imaging patients with neurological conditions, including imaging of localisation of epileptogenic foci in the
presurgical evaluation of partial temporal epilepsy.
FEVER
For the investigation of pyrexia of unknown origin.
IRISH MEDICINES BOARD
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