Fluorodeoxyglucose euro-pet

Fludeoksyglukoza Euro-PET, 300 to 3100 MBq/ml, solution for injection
Fluorodeoxyglucose ( F)
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, please consult the nuclear medicine physician supervising the procedure.
• If you experience any adverse reactions, including any not listed in this leaflet, inform the nuclear medicine physician. See section 4.

Leaflet contents
1. What Fludeoksyglukoza Euro-PET is and what it is used for
2. Important information before using Fludeoksyglukoza Euro-PET
3. How to use Fludeoksyglukoza Euro-PET
4. Possible side effects
5. How to store Fludeoksyglukoza Euro-PET
6. Contents of the pack and other information

1. What Fludeoksyglukoza Euro-PET is and what it is used for
This is a radiopharmaceutical product intended solely for diagnostic use.
The active substance in Fludeoksyglukoza Euro-PET is fluorodeoxyglucose ( F). This product is used to perform diagnostic imaging of parts of the patient's body.
After injection of a small amount of Fludeoksyglukoza Euro-PET, images obtained during scanning with a special device allow the physician to record images and locate disease or determine its progression.
Use of Fludeoksyglukoza Euro-PET involves exposure to small doses of radiation. Your treating physician and the nuclear medicine physician have determined that the clinical benefits of using this radiopharmaceutical outweigh the risks associated with radiation exposure.

2. Important information before using Fludeoksyglukoza Euro-PET

When not to use Fludeoksyglukoza Euro-PET

• if the patient is allergic to fluorodeoxyglucose ( F) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before receiving Fludeoksyglukoza Euro-PET, discuss with the nuclear medicine physician if:

• the patient has diabetes that is currently uncontrolled;
• the patient has kidney disease;
• the patient recently underwent surgery, chemotherapy, or radiotherapy;
• the patient has an infectious or inflammatory condition.

Inform the nuclear medicine physician if:

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

This medicine contains up to 49.5 mg of alcohol (ethanol) per 15 ml injection solution, 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.
The small amount of alcohol in this medicine will not cause noticeable effects.
Before receiving Fludeoksyglukoza Euro-PET, the patient should:

• drink plenty of water before the examination to maximize urine output during the first hours after the scan;
• avoid strenuous physical activity before the examination;
• remain fasting for at least 4 hours.

Children and adolescents
Patients under 18 years of age should inform the nuclear medicine physician.

Fludeoksyglukoza Euro-PET and other medicines
Inform the nuclear medicine physician about all medicines currently or recently taken, or those planned for use, as they may affect interpretation of imaging results:

• all medicines that may alter blood glucose levels (glycemia), such as anti-inflammatory drugs (corticosteroids), antiepileptic drugs (valproate, carbamazepine, phenytoin, phenobarbital), drugs affecting the nervous system (adrenaline, noradrenaline, dopamine, etc.),
• glucose,
• insulin,
• medicines used to stimulate blood cell production.

Fludeoksyglukoza Euro-PET with food and drink
The patient should remain fasting for at least 4 hours before administration of the medicine.
The patient should drink large amounts of water and avoid sugary drinks.
The nuclear medicine physician will measure blood glucose levels before administering the product. High blood glucose levels (hyperglycemia) may significantly interfere with the physician's ability to interpret the scan results.

Pregnancy and breastfeeding
If there is a possibility of pregnancy, delayed menstruation, or breastfeeding, inform the nuclear medicine physician before administration of Fludeoksyglukoza Euro-PET.
If in doubt, it is important to consult the nuclear medicine physician supervising the procedure.

If the patient is pregnant
The nuclear medicine physician may administer this product to a pregnant patient only if the expected benefits outweigh the potential risks.

If the patient is breastfeeding
Breastfeeding must be interrupted for 12 hours after injection of the product. Breast milk expressed during this time should be discarded.
Resuming breastfeeding should be discussed with the nuclear medicine physician supervising the procedure.

If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult the nuclear medicine physician before receiving this product.

Driving and operating machinery
It is considered unlikely that Fludeoksyglukoza Euro-PET will affect the ability to drive or operate machinery.

Fludeoksyglukoza Euro-PET contains ethanol
This medicinal product contains a small amount of ethanol (alcohol), less than 100 mg per dose.

3. How to use Fludeoksyglukoza Euro-PET

There are strict regulations governing the use, handling, and disposal of radiopharmaceuticals.
Fludeoksyglukoza Euro-PET may only be used in specially controlled facilities. The product may be prepared and administered exclusively by appropriately trained personnel qualified in the safe use of the product. These individuals will ensure safe administration of the product and inform the patient about the procedures being performed.
The nuclear medicine physician responsible for carrying out the procedure will determine the appropriate dose of Fludeoksyglukoza Euro-PET for the patient. This will be the smallest amount necessary to obtain the required diagnostic information.
The usual recommended dose for an adult is 100 to 400 MBq (depending on the patient's body weight, the type of imaging equipment used, and the acquisition mode). The megabecquerel (MBq) is a unit used to express radioactivity.

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

Administration of Fludeoksyglukoza Euro-PET and procedure details
Fludeoksyglukoza Euro-PET is administered intravenously.
A single injection is sufficient to perform the required imaging examination.
After the injection, the patient should remain in complete rest. Reading or talking is not allowed. Additionally, the patient will be offered a drink and will be asked to urinate immediately after completion of the procedure.
During imaging, the patient must remain completely still. Movement and talking are not allowed.

Duration of the procedure:
The nuclear medicine physician will inform the patient about the expected duration of the procedure. Fludeoksyglukoza Euro-PET is administered as a single intravenous injection. Imaging is usually performed 45–60 minutes after administration of the product. Image acquisition typically lasts between 30 and 60 minutes.

After administration of Fludeoksyglukoza Euro-PET to the patient, the following should be observed:

• Avoid close contact with young children and pregnant women for 12 hours after injection.
• Urinate frequently to help eliminate the product from the body.

The nuclear medicine physician will inform the patient if any special precautions are necessary after receiving the product. If you have any questions, please consult the nuclear medicine physician.

Administration of a higher than recommended dose of Fludeoksyglukoza Euro-PET
The likelihood of overdose is extremely low, as Fludeoksyglukoza Euro-PET is administered as a single dose under strictly controlled conditions by the nuclear medicine physician performing the procedure. However, in the event of an overdose, appropriate treatment will be initiated. In particular, the supervising nuclear medicine physician may recommend drinking large amounts of fluids to facilitate elimination of Fludeoksyglukoza Euro-PET from the body (the product is primarily eliminated from the body via the kidneys in urine).

If you have any further doubts regarding the use of Fludeoksyglukoza Euro-PET, please consult the nuclear medicine physician supervising the procedure.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not
everyone will experience them.
Administration of this radiopharmaceutical product will result in a small dose of
ionizing radiation, which is associated with a small risk of developing cancer or
congenital abnormalities.
The treating physician has assessed that the benefits of using the radiopharmaceutical
product outweigh the risks associated with radiation exposure.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this
leaflet, inform the nuclear medicine physician.
Adverse reactions can be reported directly to the Department of Monitoring Adverse
Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices
and Biocidal Products
Al. Jerozolimskie 181C
PL-02-222 Warsaw
Tel.: + 48 22 49 21 100
Fax: + 48 22 49 21 109
e-mail: [email protected].
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the
medicinal product.

5. How to store Fludeoksyglukoza Euro-PET

The patient is not responsible for storage of the product. The product is stored under the supervision of a specialist in an appropriate facility. The product must be stored in accordance with national regulations concerning the handling of radioactive materials.
The following information is intended exclusively for specialists.
Do not use this product after the expiry date stated on the label.
Do not store above 40°C.
Store in a location shielded with a lead radiation shield.
Store in the original packaging.
Chemical and physical stability of the product has been demonstrated for 14 hours at 20°C. From a microbiological standpoint, the product should be used immediately, unless the method of opening/dilution excludes the risk of microbiological contamination.
If the product is not used immediately, the user is responsible for the duration and conditions of storage during use.

6. Contents of the package and other information

What Fludeoksyglukoza Euro-PET contains

• The active substance is fluorodeoxyglucose (F). On the date and at the time of calibration, 1 ml of injection solution contains fluorodeoxyglucose (F) with radioactivity ranging from 300 MBq to 3100 MBq.
• The other components are ethanol, sodium chloride, sodium dicitrate, sodium citrate, and water for injections.

What Fludeoksyglukoza Euro-PET looks like and contents of the pack
Fludeoksyglukoza Euro-PET is a clear, colourless solution for injection.
Fludeoksyglukoza Euro-PET is supplied in multiple-dose vials with a capacity of 15 ml, made of inert glass type I, closed with a rubber stopper.
One vial contains up to 15 ml of solution, corresponding to a radioactive concentration of 300 to 3100 MBq/ml at the time and date of calibration.

Marketing Authorisation Holder
Alliance Medical RP Berlin GmbH
Max Planck Str. 4
12489 Berlin
Germany
Tel.: +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 authorised in the EEA Member States under the following names:
Austria: [F]Fludeoxyglucose Alliance Medical 300-3100 MBq/ml Injektionslösung
Czech Republic: [F]FDG-FR
Estonia: [F]FDG-FR
Netherlands: [F]FDG Alliance Medical 300-3100 MBq/ml oplossing voor injectie
Germany: [F]FDG Alliance Medical 300-3100 MBq/ml Injektionslösung
Latvia: [F]FDG-FR 300 - 3100 MBq/ml šķīdums injekcijām
Lithuania: Fludeoxyglucose (F) Alliance Medical 300-3100 MBq/ml injekcinis tirpalas
Luxembourg: [18F]FDG-FR 300 à 3100 MBq/ml
Poland: Fludeoksyglukoza Euro-PET
Slovak Republic: [F]FDG-FR
Sweden: Fludeoxyglucose (18F) Alliance Medical