Fludeoksiglukoza Euro-pet

Patient Leaflet: Patient Information

Fludeoxyglucose Euro-PET, 300 to 3100 MBq/ml, solution for injection

Fluorodeoxyglucose (FDG)

Please read this leaflet carefully before using the medicine, as it contains important information for you.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a nuclear medicine doctor who supervises the procedure.
• If you experience any side effects, including any not listed in this leaflet, you should tell your nuclear medicine doctor. See section 4.

Table of Contents of the Leaflet

1. What is Fludeoxyglucose Euro-PET and what is it used for

2. Important information before using Fludeoxyglucose Euro-PET

3. How to use Fludeoxyglucose Euro-PET

4. Possible side effects

5. How to store Fludeoxyglucose Euro-PET

6. Contents of the pack and other information

1. What is Fludeoxyglucose Euro-PET and what is it used for

This is a radiopharmaceutical product intended for diagnostic use only.
The active substance contained in Fludeoxyglucose Euro-PET is fluorodeoxyglucose
(FDG). The product is intended for performing diagnostic imaging examinations of parts
of the patient's body.
After injecting a small amount of Fludeoxyglucose Euro-PET, images obtained during the examination using a special device allow the doctor to record images and
localize the disease or determine its progression.
The use of Fludeoxyglucose Euro-PET results in exposure to small doses of radiation. The treating doctor and the nuclear medicine doctor have assessed that the clinical benefits of using the radiopharmaceutical product outweigh the risk of radiation exposure.

2. Important information before using Fludeoxyglucose Euro-PET

When not to use Fludeoxyglucose Euro-PET

• if the patient has been found to be hypersensitive to fluorodeoxyglucose (FDG) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting the administration of Fludeoxyglucose Euro-PET, you should discuss it with your nuclear medicine doctor if:

• the patient has diabetes and it is not currently controlled;
• the patient has kidney disease;
• the patient has recently undergone surgery, chemotherapy, or radiotherapy;
• the patient has an infectious or inflammatory disease.

You should tell your nuclear medicine doctor if:

• the patient is pregnant or thinks she may be pregnant;
• the patient is breastfeeding.

This medicine contains a maximum of 49.5 mg of ethanol (alcohol) per 15 ml solution for injection, which is equivalent to 3.3 mg/ml (0.33% w/v). The amount of alcohol in 15 ml of this medicine is equivalent to less than 1 ml of beer or 1 ml of wine.
A small amount of alcohol in this medicine will not cause noticeable effects.

Before receiving Fludeoxyglucose Euro-PET, the patient should:

• drink plenty of water before the examination to maximize urine frequency in the first hours after the examination;
• avoid strenuous physical activity before the examination;
• fast for at least 4 hours.

Children and adolescents

Patients who have not reached the age of 18 should inform their nuclear medicine doctor.

Fludeoxyglucose Euro-PET and other medicines

You should tell your nuclear medicine doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, as they may affect the interpretation of the imaging results:

• all medicines that may affect blood sugar levels (glycemia), such as anti-inflammatory medicines (corticosteroids), antiepileptic medicines (valproate, carbamazepine, phenytoin, phenobarbital), medicines that affect the nervous system (adrenaline, noradrenaline, dopamine…),
• glucose,
• insulin,
• medicines used to increase blood cell production.

Fludeoxyglucose Euro-PET with food and drink

The patient should fast for at least 4 hours before administration of the medicine.
The patient should drink plenty of water and avoid sugary drinks.
Your nuclear medicine doctor will perform a blood glucose measurement before administering Fludeoxyglucose Euro-PET. High blood glucose levels (hyperglycemia) may significantly hinder the interpretation of the result by the nuclear medicine doctor.

Pregnancy and breastfeeding

In case of suspected pregnancy, delayed menstruation, or breastfeeding, you should inform your nuclear medicine doctor before administering Fludeoxyglucose Euro-PET.
If there is any uncertainty, it is essential to consult a nuclear medicine doctor who will supervise the procedure.
If the patient is pregnant
Your nuclear medicine doctor may administer this product to a pregnant patient only when the expected benefits outweigh the potential risk.
If the patient is breastfeeding
In the case of breastfeeding, the patient must stop breastfeeding for 12 hours after injection. The expressed milk should be discarded.
Resuming breastfeeding should be discussed with the nuclear medicine doctor who supervises the procedure.
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her nuclear medicine doctor before receiving this product.

Driving and using machines

It is considered unlikely that Fludeoxyglucose Euro-PET will affect the ability to drive and use machines.

Fludeoxyglucose Euro-PET contains ethanol

This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.

3. How to use Fludeoxyglucose Euro-PET

There are strict regulations regarding the use, handling, and disposal of radiopharmaceutical products.
Fludeoxyglucose Euro-PET can only be used in specially controlled rooms.
The product can only be prepared and administered by properly trained personnel with qualifications in the safe use of the product.
These personnel will ensure the safe administration of the product and inform the patient about the procedures being performed.
Your nuclear medicine doctor responsible for the procedure will select the appropriate dose of Fludeoxyglucose Euro-PET for the patient.
This will be the smallest amount necessary to obtain the required information.
Usually, the recommended dose for an adult is between 100 and 400 MBq (depending on the patient's body weight, the type of device used for imaging, and the acquisition mode). Megabecquerel (MBq) is a unit used to express radioactivity.

Use in children and adolescents

In children and adolescents, the dose administered will depend on the child's body weight.

Administration of Fludeoxyglucose Euro-PET and procedure

Fludeoxyglucose Euro-PET is administered intravenously.
A single injection is sufficient to perform the necessary imaging examination.
After injection, the patient should remain in a state of complete rest. The patient should not read or talk.
Additionally, the patient will be offered a drink and will be asked to urinate immediately after the procedure.
During the imaging examination, the patient must remain in complete rest. The patient must not move or talk.

Duration of the procedure:

Your nuclear medicine doctor will inform you about the expected duration of the procedure.
Fludeoxyglucose Euro-PET is administered in a single intravenous injection.
Imaging is usually performed 45-60 minutes after administration of the product.
The acquisition of images by the device takes from 30 to 60 minutes.

After administration of Fludeoxyglucose Euro-PET to the patient:

• avoid close contact with small children and pregnant women for 12 hours after injection,
• frequently urinate to remove the product from the body.

Your nuclear medicine doctor will inform you if any special precautions are necessary after receiving Fludeoxyglucose Euro-PET.
If you have any questions, you should consult your nuclear medicine doctor.

Use of a higher dose of Fludeoxyglucose Euro-PET than recommended

There is a very low probability of overdose, as Fludeoxyglucose Euro-PET is administered in a single dose under strictly controlled conditions by a nuclear medicine doctor performing the procedure.
However, in case of overdose, appropriate treatment will be initiated.
In particular, the nuclear medicine doctor supervising the procedure may recommend drinking plenty of fluids, which will facilitate the removal of Fludeoxyglucose Euro-PET from the body (the product is mainly eliminated from the body by the kidneys with urine).
If you have any further doubts about the use of Fludeoxyglucose Euro-PET, you should consult 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.
Administration of this radiopharmaceutical product will result in exposure to a small dose of ionizing radiation, which is associated with a small risk of cancer or congenital anomalies.
Your treating doctor has assessed that the benefits of using the radiopharmaceutical product outweigh the risk of radiation exposure.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should tell your nuclear medicine doctor.
Side effects can be reported directly to the Department for Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Jerozolimskie Avenue 181C
02-222 Warsaw
Phone: +48 22 49 21 100
Fax: +48 22 49 21 109
e-mail: [email protected].
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fludeoxyglucose Euro-PET

The patient is not responsible for storing the product.
The product is stored under the supervision of a specialist in a suitable room.
The product should be stored in accordance with national regulations regarding the handling of radioactive products.
The following information is intended for healthcare professionals only.
Do not use this product after the expiry date stated on the label.
Do not store above 25°C.
Store in a lead-lined radiation shield.
Store in the original packaging.
Chemical and physical stability of the product has been demonstrated during use for 14 hours at 20°C.
From a microbiological point of view, the product should be used immediately, unless the opening/dilution method precludes the risk of microbial contamination.
If the product is not used immediately, the user is responsible for the storage time and conditions during use.

6. Contents of the pack and other information

What Fludeoxyglucose Euro-PET contains

• The active substance is fluorodeoxyglucose (FDG). On the day of and at the time of calibration, 1 ml of the solution for injection contains fluorodeoxyglucose (FDG) with a radioactivity of 300 MBq to 3100 MBq.
• The other ingredients of the medicine are ethanol, sodium chloride, disodium citrate, trisodium citrate, and water for injections.

What Fludeoxyglucose Euro-PET looks like and contents of the pack

Fludeoxyglucose Euro-PET is a clear, colorless solution for injection.
Fludeoxyglucose Euro-PET is packaged in 15 ml multidose vials made of neutral glass type I, closed with a rubber stopper.
One vial contains up to 15 ml of solution, which corresponds to a radioactivity dose of 300 to 3100 MBq/ml on the day of and at the time of calibration.

Marketing authorization holder

Alliance Medical RP Berlin GmbH
Max Planck Str. 4
12489 Berlin
Germany
Phone: +49 (0)30 6392 2492
Fax: +49 (0)30 6392 2499

Manufacturer

Alliance Medical RP Berlin GmbH
Max-Planck-Str. 4
12489 Berlin
Germany
Alliance Medical RP Sp. z o.o.
Szeligowska 3
05-850 Szeligi
Poland
Alliance Medical RP GmbH
Spessartstr. 9
53119 Bonn
Germany

The medicinal product is authorized to be placed on the market in the EEA Member States under the following names:

Austria:
[18F]Fludeoxyglucose Alliance Medical 300-3100 MBq/ml Injektionslösung
Czech Republic:
[18F]FDG-FR
Estonia:
[18F]FDG-FR
Netherlands:
[18F]FDG Alliance Medical 300-3100 MBq/ml oplossing voor injectie
Germany:
[18F]FDG Alliance Medical 300-3100 MBq/ml Injektionslösung
Latvia:
[18F]FDG-FR 300 - 3100 MBq/ml šķīdums injekcijām
Lithuania:
Fludeoxyglucose (18F) Alliance Medical 300-3100 MBq/ml injekcinis tirpalas
Luxembourg:
[18F]FDG-FR 300 à 3100 MBq/ml solution pour injection
Poland:
Fludeoksyglukoza Euro-PET
Slovakia:
[18F]FDG-FR
Sweden:
Fludeoxyglucose (18F) Alliance Medical

Date of last revision of the leaflet: 15-05-2025