Package leaflet: Information for the user

FDGtomosil 550 MBq/mL solution for injection
Fluorodeoxyglucose ( F)
Please read all of this leaflet carefully before the medicinal product is administered,
because it contains important information for you.

Keep this leaflet so that you can read it again if necessary.
Consult your doctor if you have any further questions.
If you experience any adverse reactions, including those not listed in this leaflet, inform your doctor or nurse.

Table of contents of the leaflet:

What FDGtomosil is and what it is used for
Important information before administration of FDGtomosil
How to use FDGtomosil
Possible side effects
How to store FDGtomosil
Contents of the pack and other information

1. What FDGtomosil is and what it is used for

This product is intended for diagnostic use only.
The medicine named FDGtomosil contains a radioactive substance called Fluorodeoxyglucose (F) in the form of a solution for injection. FDGtomosil is used to perform a diagnostic imaging procedure known as positron emission tomography (PET) to visualize specific parts of the body.
After intravenous administration, FDGtomosil enables the generation of images that provide the physician with additional information about a disease and its stage of progression.

2. Important information before using FDGtomosil

When not to use FDGtomosil:

if the patient is allergic to fludeoxyglucose (F) or to any of the other components of FDGtomosil (listed in section 6).

Warnings and precautions
Special caution is required

in patients with diabetes or elevated blood glucose levels,
in patients with impaired kidney function.

The patient should inform the doctor if:

they are pregnant or suspect they may be pregnant,
they are breastfeeding,
they have recently undergone surgical procedures, chemotherapy, or radiotherapy.

Before administration of FDGtomosil

the patient must remain fasting for at least 4 hours,
avoid physical exertion,
drink plenty of water before the examination, to ensure frequent urination during the first hours after FDGtomosil administration.

Children and adolescents
The doctor should be informed if the patient is under 18 years of age.
FDGtomosil and other medicines
The patient should inform the doctor about all medicines taken recently or currently (including
medicines purchased without a prescription), as they may affect the interpretation of the results of the examination using FDGtomosil.
Examples of such medicines include:

all medicines that may cause changes in blood glucose (sugar) levels, such as: drugs used in inflammatory diseases (corticosteroids), antiepileptic drugs (valproic acid, carbamazepine, phenytoin, phenobarbital), drugs affecting the nervous system (adrenaline, noradrenaline, dopamine, etc.),
glucose,
insulin,
drugs containing agents that stimulate blood cell production.

FDGtomosil with food and drink
Before the examination, the patient should drink only fluids not containing sugar.
FDGtomosil is administered only to patients who have not consumed food for at least 4 hours prior to administration.
Blood glucose levels should be measured before administration of the product, as high blood sugar levels (hyperglycemia) may interfere with the interpretation of the examination results.
Pregnancy and breastfeeding
A patient who is breastfeeding or pregnant, suspects she may be pregnant, or has delayed menstruation, must consult a doctor before administration of FDGtomosil.
If you are pregnant
The doctor will administer this medicine only if the benefits outweigh the potential risks, or will consider performing the examination only if absolutely necessary.
If you are breastfeeding
After administration of FDGtomosil during breastfeeding, breastfeeding must be interrupted for 12 hours after injection and milk expressed during this period should be discarded. The patient should consult the doctor to determine when breastfeeding can be resumed.
Driving and operating machinery
The effect of FDGtomosil on the ability to drive and operate machinery is unlikely.
Important information about certain components of FDGtomosil
FDGtomosil contains sodium, which should be taken into account in patients on a sodium-controlled diet.
FDGtomosil contains small amounts of anhydrous ethanol.

3. How to use FDGtomosil

There are strict rules and regulations regarding the use of radioactive medicinal products. This medicine
will be administered by appropriately trained personnel who will pay special attention to safety aspects
and who will inform the patient how to behave at each stage of the examination.
Before injecting the medicine, the doctor may recommend taking a blood sample to check blood
glucose levels.
The doctor will determine the diagnostic dose of FDGtomosil to be administered to the patient. This will
be the smallest dose necessary to obtain images providing the required information about the disease.
The FDGtomosil product will be administered as an intravenous injection. The usual recommended dose
for adults ranges from 100 to 400 MBq (megabecquerel – a unit measuring radioactive activity).

Use of the product in children and adolescents
A reduced dose will be used in children and adolescents.

Injection of FDGtomosil and performance of the procedure
FDGtomosil is administered intravenously. A single injection is sufficient to perform the examination.
After injection, the patient will be asked to drink large amounts of fluids that do not contain sugar and
will be advised to urinate frequently.
After administration, physical exertion should be avoided. The patient should rest comfortably, without
reading or talking.

Duration of the procedure
The doctor will inform the patient about the expected duration of the procedure. The examination will
begin 45 to 60 minutes after injection of the medicine. The image acquisition time depends on the PET
equipment used and therefore may last from 30 to 60 minutes.

After injection of FDGtomosil, the patient should:

avoid contact with young children and pregnant women for 12 hours after injection of the product,
urinate frequently to reduce radiation exposure to the urinary bladder.

The doctor will inform the patient if additional precautionary measures are required. In case of any
questions, please consult your doctor.

Administration of a higher than recommended dose of FDGtomosil
Overdose is almost impossible because the patient receives a single diagnostic dose of the medicine,
carefully prepared under medical supervision. However, in the event of an overdose, the doctor will
recommend drinking large amounts of fluids to facilitate elimination of FDGtomosil from the body.

If you have any further questions about the use of FDGtomosil, please consult your doctor or a specialist
in nuclear medicine.

4. Possible adverse reactions

Like all medicinal products, FDGtomosil may cause adverse reactions, although not everyone will
experience them.
The diagnostic medicinal product FDGtomosil contains a small amount of radioactive substance which
will be administered into the body, entailing a risk of tumours and congenital abnormalities.
If any adverse reactions occur, consult a physician or a nuclear medicine specialist.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the package leaflet, inform
your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring
Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical
Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, phone: +48 22 49 21 301, fax:
+48 22 49 309, e-mail: [email protected]. Reporting adverse reactions enables better assessment of
the safety of the medicinal product.

5. How to store FDGtomosil

FDGtomosil is not available for patient storage. The trained personnel at the medical facility where the examination will be performed are responsible for storing this medicinal product.
Radiopharmaceutical products such as this medicinal product must be stored in accordance with national regulations regarding radioactive substances.
The following information is provided solely for the information of medical personnel.
Do not use FDGtomosil after the expiry date stated on the label.
The Summary of Product Characteristics is supplied as a separate document with each medicinal product package. This document contains additional practical and scientific information for medical personnel regarding handling of the product.

6. Contents of the pack and other information

What FDGtomosil contains

The active substance is fludeoxyglucose (F). Each ml of injection solution contains fludeoxyglucose (F) with a radioactivity of 550 MBq (megabecquerel – a unit measuring radioactive activity) at the time of calibration.
Other components are: sodium chloride, anhydrous ethanol, and water for injections.

What FDGtomosil looks like and contents of the pack
FDGtomosil is a clear, colourless or slightly yellow injection solution supplied in vials packed in an outer protective container shielding against ionizing radiation. The medicinal product contained in the vial corresponds to an activity of 247 to 5500 MBq at the time of calibration.
The medicine is administered to the patient using a syringe in a special shield.

Marketing Authorisation Holder and Manufacturer
Maria Skłodowska-Curie National Research Institute of Oncology
5 W.K. Roentgen Street
02-781 Warsaw
Poland

Detailed information on this product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: http://www.urpl.gov.pl