ERtracER Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fludeoxyglucose [18F]

Available from:

Curium Pharma Ireland Limited

ATC code:

V09IX; V09IX04

INN (International Name):

Fludeoxyglucose [18F]

Dosage:

110-10,000 megabecquerel(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other diagnostic radiopharmaceuticals for tumour detection; fludeoxyglucose (18F)

Authorization status:

Marketed

Authorization date:

2015-02-27

Patient Information leaflet

PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
ERTRACER SOLUTION FOR INJECTION
FLUDEOXYGLUCOSE (
18
F)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE ADMINISTERED THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR
YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your Nuclear Medicine doctor
who will supervise the procedure.
•
If you get any side effects, talk to your Nuclear Medicine doctor.
This includes any possible side effects not listed in
this leaflet.
WHAT IS IN THIS LEAFLET:
1. What ERtracER is and what it is used for.
2. What you need to know before ERtracER is administered.
3. How ERtracER is used.
4. Possible side effects.
5. How ERtracER is stored.
6. Contents of the pack and other information.
1. WHAT ERTRACER IS AND WHAT IT IS USED FOR.
This medicine is a radiopharmaceutical product for diagnostic use
only. The active substance contained in ERtracER is
fludeoxyglucose (
18
F) and is designed for the capture of diagnostic images of some parts
of your body.
Once a small amount of ERtracER has been injected, medical images that
are obtained with a special camera will enable
the doctor to capture images and see where your illness is or how it
is progressing.
Your body contains millions of living cells. All the cells use sugar
(glucose) for energy. When you have certain medical
conditions, some parts of your body will use more glucose than normal.
Doctors use this change in the amount of glucose
used to help identify and pinpoint the site of certain medical
conditions.
When ERtracER is given to you, a small amount of radioactive glucose
spreads around your body and reaches the areas
where glucose is being used the most.
By using a special camera, known as a PET scanner or a gamma-camera,
pictures (images) of the radiation coming from the
ERtracER let your doctor ‘see’ where the radioactive glucose is
being used the most. He/she can then use this to help
identify (diagnose) and pinpoint sites where you have a particular
medical condition

Summary of Product characteristics

Health Products Regulatory Authority
13 March 2024
CRN00F6C3
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ERtracER Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains 110 – 10,000 MBq fludeoxyglucose (18F) at the date and
time of calibration. The activity per vial ranges from 110
MBq to 50,000 MBq at the date and time of calibration.
Fluorine (18F) decays to stable oxygen (18O) with a half-life of 110
minutes by emitting positronic radiation of maximum
energy of 634 keV, followed by photonic annihilation radiations of 511
keV.
Excipients with known effects:
Each ml of fludeoxyglucose (18F) contains 5.5 mg of sodium chloride.
Each ml of fludeoxyglucose (18F) contains up to 7.8 mg of ethanol.
For a 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 medical product is for diagnostic use only.
Fludeoxyglucose (
18
F) is indicated for use with positron emission tomography (PET) in
adults and the 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 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