Fdgtomosil

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the user

FDGtomosil 550 MBq/mL solution for injection

Fludeoxyglucose (F)

You should read the contents of the leaflet before using the radiopharmaceutical product,

as it contains important information for the patient.

• -You should keep this leaflet, so that you can read it again if you need to.
• You should consult your doctor if you have any further doubts.
• If you experience any undesirable effects, including those not mentioned in the leaflet, you should inform your doctor or nurse.

Table of contents of the leaflet:

• 1. What is FDGtomosil and what is it used for
• 2. Important information before using FDGtomosil
• 3. How to use FDGtomosil
• 4. Possible side effects
• 5. How to store FDGtomosil
• 6. Contents of the packaging and other information.

1. What is FDGtomosil and what is it used for

The product is intended exclusively for diagnostic purposes.
The medicine called FDGtomosil contains a radioactive substance, which is
Fludeoxyglucose (F) in the form of a solution for injection. FDGtomosil is used to perform an examination called positron emission tomography (PET) to radiologically visualize individual parts of the body.
FDGtomosil, after intravenous administration, will allow images to be obtained, on the basis of which the doctor will obtain
more information about the disease and its stage of advancement.

2. Important information before using FDGtomosil

When not to use FDGtomosil:

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

Warnings and precautions

Particular caution should be exercised

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

The patient should inform the doctor if:

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

Before administering FDGtomosil

• you should fast for at least 4 hours,
• avoid physical exertion,
• drink plenty of water before the examination to frequently urinate 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 doctor should be informed about all medicines taken recently or currently (including those purchased without a prescription), as they may affect the interpretation of the results of the examination with FDGtomosil.
Examples of such medicines are:

• all medicines that can cause changes in blood glucose levels, such as: medicines used in inflammatory diseases (corticosteroids), medicines used in the treatment of epilepsy (valproic acid, carbamazepine, phenytoin, phenobarbital), medicines affecting the nervous system (adrenaline, noradrenaline, dopamine, etc.),
• glucose,
• insulin,
• medicines containing factors that increase blood cell production.

FDGtomosil with food and drink

Before the examination, the patient should only drink sugar-free fluids.
FDGtomosil is administered only to patients who have not eaten for at least 4 hours before administration.
Blood glucose levels should be measured before administering the product, as high blood sugar levels (hyperglycemia) may make it difficult to interpret the results of the examination.

Pregnancy and breastfeeding

A patient who is breastfeeding or is pregnant, suspects she may be pregnant, or has a delayed menstrual period, should consult a doctor before administering FDGtomosil.

If you are pregnant

The doctor will administer this medicine only if the benefits outweigh the potential risks or will consider this examination only if it is absolutely necessary.

If you are breastfeeding

In the event of using FDGtomosil during breastfeeding, you should stop breastfeeding for 12 hours after injection and discard the expressed milk during this period. To determine the time when you can resume breastfeeding, you should consult a doctor.

Driving and using machines

The effect of FDGtomosil on the ability to drive and use machines is unlikely.

Important information about some components of FDGtomosil

The medicine contains sodium, which should be taken into account in patients controlling their sodium intake.
FDGtomosil contains small amounts of anhydrous ethanol.

3. How to use FDGtomosil

There are strict rules and regulations regarding the use of radioactive products. This medicine will be administered by properly trained personnel who will pay particular attention to safety and inform the patient how to proceed at each stage of the examination.
Before injecting the medicine, the doctor may recommend a blood test to check blood glucose levels.
The doctor will determine the dose of FDGtomosil for diagnostic purposes, which will be administered to the patient. This will be the smallest dose necessary to obtain images that provide the desired information about the disease.
FDGtomosil will be administered intravenously. The usual recommended dose for adults is between 100 and 400 MBq (megabecquerel - a unit of measurement of radioactive activity).

Use of the product in children and adolescents

A smaller dose will be used in the case of children and adolescents.

Injection of FDGtomosil and procedure

FDGtomosil is administered intravenously. One injection is sufficient to perform the examination. After injecting the product, the patient will be asked to drink plenty of sugar-free fluids and will be informed about the need to urinate frequently.
After administration, you should avoid physical exertion, lie comfortably, and not read or talk.

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 the injection of the medicine. The image acquisition time depends on the PET equipment and may last from 30 to 60 minutes.

After injecting FDGtomosil, you should:

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

The doctor will inform the patient in situations requiring additional precautions. If you have any questions, you should consult a doctor.

Use of a higher than recommended dose of FDGtomosil

Overdose is almost impossible, as the patient receives a single dose of the diagnostic medicine, carefully prepared under the control of a doctor. However, in the event of an overdose, the doctor will recommend drinking plenty of fluids to facilitate the elimination of FDGtomosil from the body.
If you have any further questions about using FDGtomosil, you should consult a doctor or a specialist in nuclear medicine.

4. Possible side effects

Like all medicines, FDGtomosil can cause side effects, although they may not occur in everyone.
The diagnostic medicine FDGtomosil contains a small amount of radioactive substance, which will be administered to the body, and is associated with the risk of cancer and congenital anomalies.
If you experience any undesirable effects, you should consult a doctor or a specialist in nuclear medicine.

Reporting side effects

If you experience any undesirable effects, including those not mentioned in the leaflet, you should inform your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 309, e-mail:
ndl@urpl.gov.pl. By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store FDGtomosil

FDGtomosil is not available to the patient for storage. The storage of this medicine is the responsibility of the trained personnel of the medical center where the examination will be performed.
Radioactive products such as this medicine should be stored in accordance with national regulations regarding radioactive substances.
The following data are for informational purposes only for medical personnel.
Do not use FDGtomosil after the expiration date, which is stated on the label.
The characteristics of the medicinal product are attached as a separate document to each packaging of the medicine. The characteristics include additional practical and scientific information for medical personnel on handling the product.

6. Contents of the packaging and other information

What FDGtomosil contains

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

What FDGtomosil looks like and what the packaging contains

FDGtomosil is a clear, colorless or slightly yellow solution for injection supplied in vials packaged in external shielding packaging, which protects against ionizing radiation. The medicine contained in the vial corresponds to an activity of 247 to 5500 MBq at the time of calibration.
The patient is administered the medicine in a syringe with special shielding.

Responsible entity and manufacturer

National Institute of Oncology Maria Skłodowska-Curie - State Research Institute
ul. W.K. Roentgena 5

• 02-781 Warsaw, Poland

Date of leaflet approval: 30.11.2020

Detailed information about 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