Skip to Content

ERTRACER TM - FLUDEOXYGLUCOSE (18F) INJECTION SOLUTION FOR INJECTION

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

ERtracERTM
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
18
Fludeoxyglucose ( F) Injection
Read all of this leaflet carefully before you are administered this
medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your referring doctor
or the specialist physician in Nuclear Medicine who will
supervise the procedure.

If any of the side effects get serious, or if you notice any side
effects not listed in this leaflet, please tell your referring
doctor or the specialist physician in Nuclear Medicine who
has supervised the procedure.
In this leaflet:
1. What ERtracER is and what it is used for.
2. Before ERtracER is administered.
3. How ERtracER will be used.
4. Possible side effects.
5. How to store ERtracER.
6. Further information.
1. What ERtracER is and what it is used for.
What ERtracER is:
ERtracER is a type of medicine called a diagnostic
radiopharmaceutical medicine. It is used to help identify
(diagnose) and pinpoint (localise) the illness you may have.
What ERtracER is used for:
ERtracER is used to help diagnose and locate certain types of
medical illnesses, including brain problems, heart problems,
cancer, infections and inflammatory illnesses. ERtracER consists
of a sugar called deoxyglucose that is attached to a tiny amount
of a radioactive substance, known as Fluorine-18, to form a
substance called Fludeoxyglucose 18F.
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 gammacamera, 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.
This diagnostic medicine can be used to help find out:
i.
Whether you have certain brain conditions such as epilepsy,
dementia (Alzheimer’s), infections or tumours.
ii. If you have an abnormality of the heart.
iii. If you have a certain type of cancer and where it is located.
iv. How well your cancer treatment is working.
2. Before ERtracER is administered
ERtracER must never be administered:

if you are allergic (hypersensitive) to fludeoxyglucose (18F)
or any of the other ingredients of ERtracER, (see section 6
for a list of ingredients).

Take special care with ERtracER:
Tell your doctor or specialist:

If you have diabetes. The test may not give the right result if
you have high blood sugar. Also read the sections overleaf on
using other medicines and using ERtracER with food and drink.

If you have an infection or an inflammatory disease.

If you suffer from kidney problems.
Tell your doctor or the specialist in Nuclear Medicine:

If you are pregnant or believe you may be pregnant.

If you are under 18 years old.

If you are breast-feeding. Your doctor or specialist will advise
you what to do. Also read the section on pregnancy and breast
feeding.
Using other medicines
Please tell your doctor or the specialist who will supervise the
procedure if you are taking, or have recently taken, any other
medicines, even those not from your doctor or specialist, such as
treatments that you might buy in a pharmacy or in a supermarket,
since they may interfere with the results of the tests, including:

any medicine that may affect the level of glucose in your body,
such as medicines that have an effect on inflammation
(corticosteroids), medicines that are used to treat convulsions
(valproate, carbamazepine, phenytoin, phenobarbital), and
medicines that affect the nervous system (adrenaline,
noradrenaline, dopamine), as well as glucose and insulin,

any medicine that may increase the amount of blood cells in
your body.
Using ERtracER with food and drink:
Before receiving the medicine drink plenty of water during the
4 hours before you have the test.
This medicine can only be given to patients who have not eaten
anything (been fasting) for at least 4 hours.
Your blood sugar level should be measured before you receive the
medicine. If you have a high blood sugar level it will be difficult for
the specialist to understand the results of the test.
All Patients Except Diabetics:
You should not eat for 4 hours before you receive the injection but
you should continue to drink water (not tea, coffee or soft drinks). If
you have had anything to eat or drink in the 4 hours before the
injection (other than water) tell your specialist.
Diabetics:
If you are diabetic the specialist will tell you what you can eat and
drink and when you should take your diabetic drugs so that the test
will work. You should continue to drink water (not tea, coffee or
soft drinks). The test may not give the right result if you have high
blood glucose.
Pregnancy and breast-feeding
You must tell the specialist before the injection of ERtracER if there
is a possibility that you might be pregnant, if you have missed your
period or if you are breast-feeding.
If you are pregnant:
This diagnostic test should not normally be used by pregnant
women. Your doctor will only consider this examination during your
pregnancy in case of absolute necessity. When in doubt, it is
important to consult the specialist who will supervise the procedure.
If you are breast-feeding:
You will need to stop doing so for about 12 hours after receiving this
radioactive medicine and any maternal milk pumped should be
discarded. This is because it may harm your baby. A small amount
of this radioactive medicine could get into your breast milk. Your
doctor or specialist will advise you about when you can start breastfeeding again.
Ask your doctor or specialist who will advise you about taking any
medicines.

Before ERtracER administration you should:

avoid physical activity

drink plenty of water during the 4 hours before the test

not eat anything for at least 4 hours
After administration of ERtracER has been performed, you
should:

Urinate frequently - this will help to remove ERtracER from
your body.
If you are looking after children you should not cuddle or hug
them for about 12 hours after you have had the scan. This is
because your body will still contain a small amount of
radioactivity.
There are strict laws on the use, handling and disposal of
radiopharmaceutical products. ERtracER will only be used in a
hospital. This product will only be handled and given to you by
people who are trained and qualified to use it safely. These
persons will take special care to use the product safely and will
keep you informed of their actions.
Driving and using machines
ERtracER will not affect your ability to drive or to use machines.
Important information about some of the ingredients of
ERtracER
ERtracER contains a sugar (glucose) attached to a tiny amount of
a radioactive substance, known as Fluorine-18. This stops being
radioactive after about 4 hours.
The dose of ERtracER given to you may contain sodium at levels
greater than 1 mmol (23 mg). This is important information for
patients who are on a low sodium diet.
3. How will ERtracER be used?
ERtracER must be given to you by a qualified doctor or a person
who is a specialist in handling radioactive medicines. This
medicine is injected into one of your blood vessels (a vein) using a
needle and syringe.
The doctor or specialist supervising the procedure will decide on
the amount of ERtracER needed for the test. It will be the
smallest amount needed to obtain a result.
The amount of ERtracER that you receive for the test will be
carefully worked out. The medicine is made just for you and
contains the right amount of radioactivity that will give clear
pictures (images).
The recommended dose for an adult ranges from 100 to 400 MBq
(depending on your body mass, the type of camera used for
imaging and the way in which the images are taken). A
megabecquerel (MBq) is a metric measurement unit of
radioactivity.
Use in children
In case of use in children, the quantity to be administered will be
adapted to the child’s body mass.
Administration of ERtracER and conduct of the procedure
ERtracER is administered intravenously.
One injection is sufficient to conduct the test that your physician
needs. After injection, you will be offered a drink and asked to
urinate immediately before the test.
During the test, you will need to be completely at rest, lying
down comfortably, without reading or talking.
Duration of the procedure:
Your doctor or specialist will inform you about the usual duration
of the procedure. The time taken for the test varies and depends
on the number of pictures (images) that your doctor requires.
Normally taking the pictures (the scan) begins 45 minutes to
1 hour after your injection and takes 30 minutes to 1 hour to
complete.
If you have been administered more ERtracER than you should:
An overdose is almost impossible because you will only receive a
single dose of ERtracER precisely controlled by the specialist
supervising the procedure.

However, in the case of an overdose, you will receive the
appropriate treatment. In particular, the specialist in charge of the
procedure may recommend that you drink a lot in order to help
remove ERtracER from your body. ERtracER is removed from your
body in urine.
Should you have any further questions on the use of ERtracER,
please ask your doctor or specialist.
4. Possible side effects
Like all medicines ERtracER can cause side effects, although not
everybody gets them.
Very few side effects have been reported with ERtracER because the
amount of radioactive drug that is injected is small. There is a very
low risk of cancer and hereditary problems.
Your doctor has considered that the clinical benefit that you will
obtain from the procedure with the radiopharmaceutical overcomes
the risk due to radiation.
Possible side effects include itching, and a feeling of hotness or a
swelling where the injection is given.
If any side effects get serious, or if you notice any side effects not
listed on this leaflet, please tell your doctor or specialist.
5. How to store ERtracER
Like all medicines, ERtracER must be kept out of the reach and sight
of children. Because ERtracER is radioactive, it must always be
handled and prepared in a special facility, such as a hospital Nuclear
Medicine Department, which is licensed to receive, prepare and
store this special type of medicine. The medicine must only be given
to you by someone who is qualified to handle radioactive medicines.
Do not store above 30C. Do not use ERtracER after the expiry date
which is stated on the label. The medicine must be used within
12 hours of being made. After it is opened (by putting a needle
through the top of the stopper and removing some of the
radioactive liquid) the medicine can be used for up to 4 hours.
The container (a small glass bottle) must always be kept in an outer
container that has a specific thickness to provide radioactive
protection. Any medicine remaining after your injection will be
disposed of by the hospital in accordance with the rules for handling
this type of medicine.
6. Further information
What ERtracER contains
The active substance is fludeoxyglucose (18F). 1 ml solution for
injection contains 110-10,000 MBq fludeoxyglucose (18F) at the
date and time of calibration. The other ingredients are: Water for
Injections, Sodium Chloride and Sodium Dihydrogen Phosphate
Dihydrate.
What ERtracER looks like and contents of the pack
The medicine, ERtracER, is a clear, colourless liquid that is provided
in a small glass bottle with a rubber stopper and a cap. Because the
medicine contains a small amount of radioactivity, it will be made
especially for you and will be provided for you by your doctor just
before it is injected into your vein. The amount that will be injected
will vary depending on the diagnostic test that your doctor has
asked for. The activity per vial ranges from 110 MBq to 50,000 MBq
at the date and time of calibration.
Marketing Authorisation Holder and Manufacturer
M2i Ltd, Blackrock Clinic, Blackrock, Co. Dublin, Republic of Ireland.
The medicine is also manufactured at:
Erigal Ltd, Keele University
Erigal Ltd, Royal Preston
Science Park, Keele,
Hospital, Preston, Lancashire,
Staffordshire, UK
UK
Royal Marsden Hospital
Sutton Rd, Surrey, UK
This leaflet was revised in December 2012

Is this leaflet hard to see or read?
Phone 00 353 1 206 4266 for help

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide