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METATRACE FDG SOLUTION FOR INJECTION 3000MBQ/ML

Active substance(s): 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
- Keep this leaflet. You may need to read it again.
- If you have any further question, ask your referring doctor or the specialist
physician in Nuclear Medicine who will supervise the procedure
- If any of the side effects gets 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 will supervise the procedure.
In this leaflet:
1.
2.
3.
4.
5.

What MetaTrace FDG is and what it is used for
Before MetaTrace FDG is administered
How MetaTrace FDG will be used
Possible side effects
Further 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 designed for the capture of
radiographical 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 physician 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
- 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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Children and adolescents
Please talk to your Nuclear Medicine doctor MetaTrace FDG
Other medicines and MetaTrace FDG
Please tell your doctor or the specialist physician in Nuclear Medicine who will
supervise the procedure if you are taking or have recently taken or might take any
other medicine since they may interfere
with your physician’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
- factors increasing the production of blood cells
MetaTrace with food and drink
This medicine can only be injected in patients who have been fasting for at least 4
hours. Blood sugar should be measured before administering the medicine; indeed
a high blood glucose concentration (hyperglycaemia) can make the physician’s
interpretation more difficult.
Pregnancy and breast-feeding
You must inform the specialist physician in Nuclear Medicine before the injection 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 specialist physician in Nuclear
Medicine.
If you are pregnant:
Your doctor will only consider this examination during your pregnancy in case of
absolute necessity.
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
specialist in Nuclear Medicine who will supervise the procedure.
Please ask your doctor or the specialist physician in Nuclear Medicine who will
supervise the procedure before taking any medicines.
Before MetaTrace FDG administration you should:
-

avoid all important physical activity
drink water abundantly during the 4 hours preceding the test
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be fasting for at least 4 hours

Driving and using machines
It is considered unlikely that MetaTrace will affect your ability to drive or to use
machinery.
MetaTrace FDG contains
- small amount of ethanol (alcohol), less than 100 mg per dose and
- water for injection
According to the time of conditioning injection for the patient the content of sodium
may in some cases be greater than 1 mmol (23mg). This should be taken into account
in patients on low sodium diet.
Important information about some of the ingredients of MetaTrace FDG
According to the time of conditioning injection for the patient, the content of sodium
may in some cases be greater than 1mmol (23mg). This should be taken into account
in patient on low sodium diet.
3. HOW WILL METATRACE FDG BE USED?
There are strict laws on the use, handling and disposal of radiopharmaceutical
products.
MetaTrace FDG 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 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 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 MetaTrace FDG and conduct of the procedure
MetaTrace FDG 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 preceding
the test.
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During the test, you will need to be completely at rest, lying down comfortably,
without reading nor talking.
Duration of the procedure
Your Nuclear Medicine physician 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.
If you have been administered more MetaTrace FDG than you should
An overdose is almost impossible because you will only receive a single dose of
MetaTrace FDG precisely controlled by the Nuclear Medicine physician supervising
the procedure. However, in the case of an overdose, you will receive the appropriate
treatment. In particular, the specialist physician 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
medicine is renal, in the urine).
Should you have any further question on the use of MetaTrace FDG, please ask your
Nuclear Medicine doctor who supervise the procedure.
After administration of MetaTrace FDG, you should:
-

avoid any contact with young children for the 12 hours following the injection
urinate frequently in order to eliminate the product from your body.

4. POSSIBLE SIDE EFFECT
Like all medicines, MetaTrace FDG can cause side effects, although not everybody
gets them. This radiopharmaceutical product will deliver low amount of ionizing
radiation with very low 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.
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.
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 information is intended for the specialist only.
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This medicine will not be used after the expiry date which is stated on the label.
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
PETNET Solutions, a division of Siemens Plc.
Registered Address:
Siemens Plc. Faraday House,
Sir William Siemens Square,
Frimley,
Camberley,
Surrey GU16 8QD
Company No: 00727817
Tel: 01923 834 940
Fax: 01923 842 853

This medicinal product is authorised in the Member States of the EEA under
the following names:
France:

MetaTrace FDG, solution injectable

This leaflet was last approved in: MAY 2015
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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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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