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METATRACE FDG SOLUTION FOR INJECTION 3000MBQ/ML

Active substance(s): FLUDEOXYGLUCOSE (18-F) / FLUDEOXYGLUCOSE (18-F) / FLUDEOXYGLUCOSE (18-F)

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Package leaflet: Information for the patient
MetaTrace FDG
Read all of this leaflet carefully before you will be 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. See section 4.

What is in this leaflet
1. What MetaTrace FDG is and what it is used for
2. What you need to know before MetaTrace FDG is used
3. How MetaTrace FDG is used
4. Possible side effects
5. How MetaTrace FDG is stored
6. Contents of the pack and other information

1. What MetaTrace FDG is and what it is used for
This medicine is a radiopharmaceutical product for diagnostic use only.
The active substance contained in MetaTrace FDG is fludeoxyglucose (18F) and is
designed for the capture of diagnostic images of some parts of your body.
Once a small amount of MetaTrace FDG has been injected, medical images that
are obtained with a special camera will enable the doctor to capture images and to
see where your illness is or how it is progressing.

2.

What you need to know before MetaTrace FDG is used

MetaTrace FDG must not be used:
- if you are allergic to fludeoxyglucose (18F) or any of the other ingredients of
this medicine (listed in section 6).
Warnings and precautions
Talk to your nuclear medicine doctor before being administered MetaTrace FDG:
- if you are diabetic and your diabetes is currently not equilibrated
- if you have an infection or an inflammatory disease
- if you are affected by kidney problems
Inform your nuclear medicine doctor in the following cases;
- if you are pregnant or believe you may be pregnant
- if you are breast-feeding
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Before administration of MetaTrace FDG you should:
- drink plenty of water before the start of examination in order to urinate as often
as possible during the first hours after the study
- avoid all important physical activity
- be fasting for at least 4 hours
Children and adolescents
Please talk to your nuclear medicine doctor.
Other medicines and MetaTrace FDG
Tell your nuclear medicine doctor if you are taking, have recently taken or might
take any other medicines, since they may interfere with your doctor’s
interpretation of the images:
- any medicine that may induce a modification of the blood sugar rate
(glycaemia), such as medicine having an effect on inflammation
(corticosteroids), medicines against convulsions (valproate, carbamazepine,
phenytoin, phenobarbital), medicines affecting the nervous system (adrenalin,
noradrenalin, dopamine…),
- glucose,
- insulin,
- medicines used to increase the production of blood cells.
MetaTrace FDG with food and drink
You should be fasting for at least 4 hours before the administration of the product.
You should drink plenty of water and avoid drinking liquids containing sugar.
Your nuclear medicine doctor will measure your blood sugar before administering
the product; indeed a high blood glucose concentration (hyperglycaemia) can make
the nuclear medicine doctor’s interpretation more difficult.
Pregnancy and breast-feeding
You must inform the nuclear medicine doctor before the administration of MetaTrace
FDG if there is a possibility you might be pregnant, if you have missed your period or
if you are breast-feeding.
When in doubt, it is important to consult your nuclear medicine doctor who will
supervise the procedure.
If you are pregnant
Your nuclear doctor will only administer this product during pregnancy if a benefit is
expected which would outweigh the risks.
If you are breast-feeding
You must stop breast-feeding for 12 hours after the injection and the maternal milk
pumped must be discarded.
Resuming breast-feeding should be in agreement with the nuclear medicine doctor
who will supervise the procedure.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to
have a baby, ask the nuclear medicine doctor for advice before you will be
administered this product.

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Driving and using machines
It is considered unlikely that MetaTrace FDG will affect your ability to drive or to use
machines.
MetaTrace FDG contains
- small amount of ethanol (alcohol), less than 100 mg per dose and
- water for injection
This product may contain more than 1 mmol of sodium (23mg). You should take this
into account if you are on a low sodium diet.

3.

How MetaTrace FDG will be used

There are strict laws on the use, handling and disposal of radiopharmaceutical
products. MetaTrace FDG will only be used in special controlled areas. This product
will only be handled and given to you by people who are trained and qualified to use it
safety. These persons will take special care for the safe use of this product and will
keep you informed of their actions.
The nuclear medicine doctor supervising the procedure will decide on the quantity of
MetaTrace FDG to be used in your case. It will be the smallest quantity necessary to
get the desired information.
The quantity to be administered usually recommended for an adult ranges from 100 to
400 MBq (depending on the patient’s body mass, the type of camera used for imaging
and the acquisition mode). Mega Becquerel (MBq) is the unit used to express
radioactivity.
Use in children
In case of use in children, the quantity to be administered will be adapted to the child’s
weight.
Administration of MetaTrace FDG and conduct of the procedure
MetaTrace is administered intravenously.
One injection is sufficient to conduct the test that your doctor needs.
After injection you will need to be completely at rest, without reading or talking. Also,
you will be offered a drink and asked to urinate immediately preceding the procedure.
While the pictures are being taken, you will need to be completely at rest. You
should not move or talk.
Duration of the procedure
Your nuclear medicine doctor will inform you about the usual duration of the
procedure.
MetaTrace FDG is administered as a single injection in a vein, 45-60 minutes before
the imaging acquisition takes place. The imaging acquisition with the camera lasts 30
to 60 minutes.
After administration of MetaTrace FDG you should:
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Avoid any close contact with young children or pregnant women for the 12 hours
following the injection.
Urinate frequently in order to eliminate the product from your body.

If you have been given more MetaTrace FDG than you should
An overdose is unlikely because you will only receive a single dose of MetaTrace
FDG precisely controlled by the nuclear medicine doctor supervising the procedure.
However, in the case of an overdose, you will receive the appropriate treatment. In
particular, the nuclear medicine doctor in charge of the procedure may recommend
that you drink abundantly in order to facilitate the elimination of MetaTrace FDG
from your body (indeed the principle way of elimination of this product is renal, in the
urine).
If you have any further questions on the use of MateTrace FDG, please ask your
nuclear medicine doctor who supervises the procedure.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets
them.
This radiopharmaceutical product will deliver low amount of ionising radiation with
the least risk of cancer and hereditary abnormalities.
Your doctor has considered that the clinical benefit that you will obtain from the
procedure with the radiopharmaceutical overcomes the risk due to radiation.
You may see redness or rash at injection site.
Reporting of side effects
If you get any side effects, talk to your nuclear medicine doctor who supervises the
procedure. This includes any possible side effects not listed in this leaflet. You can
also report side effects directly via
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.

5.

How MetaTrace FDG is stored

You will not have to store this medicine. This medicine is stored under the
responsibility of the specialist in appropriate premises. Storage of
radiopharmaceuticals will be in accordance with national regulation on radioactive
materials.
The following information is intended for the specialist only.
This medicine will not be used after the expiry date which is stated on the label.

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6.

Contents of the pack and other information

What MetaTrace FDG contains
-

The active substance is fludeoxyglucose (18F). 1 ml solution for injection
contains 3000MBq at the date and time of calibration.
The other ingredients are: small amount of ethanol (alcohol), less than 100 mg
per dose and water for injection

What MetaTrace FDG looks like and contents of the pack
-

The activity per vial ranges from 300 MBq to 30000MBq at the date and time
of calibration.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Siemens Healthcare Limited
Faraday House,
Sir William Siemens Square,
Frimley,
Camberley,
Surrey GU16 8QD
United Kingdom
Manufacturer
PETNET SOLUTIONS,
a Division of Siemens plc
Lesley Harrison Building
Mount Vernon Hospital Northwood
Middlesex HA6 2RN
United Kingdom
PETNET SOLUTIONS,
a Division of Siemens plc
Heathfield Way
Nottingham City Hospital Gate 1,
Hucknall Road
Nottingham NG5 1PB
United Kingdom
This medicinal product is authorised in the Member States of the EEA under
the following names:
France:
United Kingdom:

MetaTrace FDG, solution injectable
MetaTrace FDG, solution for injection

This leaflet was last revised in: July 2016

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The complete SmPC of MetaTrace FDG is provided in the product package, with
the objective to provide healthcare professionals with other additional scientific
and practical information about the administration and use of this
radiopharmaceutical.
Please refer to the SmPC.

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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.

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