Fdg Poziton

Package Leaflet: Information for the User

FDG POZYTON, 3000 MBq/mL at calibration time, solution for injection

Fludeoxyglucose (F)

You should read the package leaflet carefully before using the radiopharmaceutical, as it contains important information for the patient.

• -You should keep this leaflet, so you can read it again if you need to.
• In case of any doubts, you should consult a doctor or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. See section 4.

Table of Contents of the Leaflet:

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

1. What FDG POZYTON is and what it is used for

The product is intended for diagnostic purposes only.
FDG POZYTON contains the radioactive substance fludeoxyglucose (F) in the form of
a solution for injection. FDG POZYTON is used to perform a test called positron emission tomography (PET) to radiologically visualize certain parts of the body.
FDG POZYTON, after intravenous administration, will allow images to be obtained, based on which
the doctor will obtain more information about the disease and its stage.

2. Important information before using FDG POZYTON

When not to use FDG POZYTON:

• -if the patient is allergic to fludeoxyglucose (F) or any of the other ingredients of FDG POZYTON (listed in section 6).

Warnings and precautions

Before administering FDG POZYTON, you should consult a nuclear medicine doctor:

• if the patient has diabetes or if diabetes is not currently controlled
• if the patient has an infection or inflammatory disease
• if the patient has kidney function disorders

You should inform the nuclear medicine doctor about the following:

• if the patient is pregnant or suspects she may be pregnant
• if the patient is breastfeeding

Before administering FDG POZYTON

• -you should drink plenty of water before the test, in order to frequently urinate in the first hours after FDG POZYTON administration.
• you should avoid physical exertion,
• you should fast for at least 4 hours,

Children and adolescents

You should inform the doctor if the patient is under 18 years old.

FDG POZYTON and other medicines

You should inform the doctor about all medicines taken recently or currently (including
over-the-counter medicines), as they may affect the interpretation of the test results with FDG POZYTON.
Examples of such medicines are:

• all medicines that may 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.

FDG POZYTON with food and drink

You should drink plenty of water and avoid drinking sugary fluids.
FDG POZYTON is administered only to patients who have not eaten for at least 4 hours before administration.
Blood glucose levels should be measured before administration, as high blood sugar levels (hyperglycemia) may make it difficult to interpret the test results.

Pregnancy, breastfeeding, and fertility

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

If the patient is pregnant

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

If the patient is breastfeeding

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

Fertility

No studies have been conducted on the effect of FDG POZYTON on fertility.

Driving and using machines

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

FDG POZYTON contains sodium

The medicine contains 3.54 mg of sodium (the main component of common salt) per milliliter.
This corresponds to 0.2% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use FDG POZYTON

There are strict rules and regulations regarding the use of radiopharmaceuticals.
This medicine will be administered by properly trained personnel who will pay special attention to the safety of use and will inform the patient how to proceed at each stage of the test.
Before injecting the medicine, the doctor may recommend taking a blood sample to check blood glucose levels.
The doctor will determine the dose of FDG POZYTON to be administered to the patient.
This will be the smallest dose necessary to obtain images that provide the desired information about the disease.
FDG POZYTON 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 in children and adolescents

In the case of using the medicine in children and adolescents, the dose of the medicine will be adjusted to the patient's body weight.

Administration of FDG POZYTON and procedure

FDG POZYTON is administered intravenously.
A single injection is sufficient to perform the test.
After injecting the medicine, 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 test 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 FDG POZYTON:

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

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

Using more than the recommended dose of FDG POZYTON

Overdose is almost impossible, as the patient receives a single dose of the medicine for diagnostic purposes, 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 FDG POZYTON from the body.
If you have any further questions about using FDG POZYTON, you should consult a doctor or a specialist in nuclear medicine.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
FDG POZYTON contains a small amount of radioactive substance that will be administered to the body, which is associated with the risk of developing tumors and congenital anomalies.
If you experience any side effects, you should consult a nuclear medicine specialist.
Reporting side effects
If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse.
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 21 309, website: https://smz.ezdrowie.gov.pl
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 FDG POZYTON

The patient will not be responsible for storing FDG POZYTON.
The storage of this medicine is the responsibility of the trained medical personnel of the medical center where the test will be performed.
Radiopharmaceuticals like this medicine should be stored in accordance with national regulations regarding radioactive substances.
The following data are for the information of medical personnel only.
Do not use FDG POZYTON after the expiry date stated on the label.
The summary of product characteristics is attached as a separate document to each pack of the medicine.
The summary of product characteristics includes additional practical and scientific information for medical personnel on handling the medicine.

6. Contents of the pack and other information

What FDG POZYTON contains

• The active substance of the medicine is fludeoxyglucose (F).
  Each milliliter of the solution for injection contains fludeoxyglucose (F) with an activity of 3000 MBq/mL at calibration time.
• The other ingredients are: sodium chloride 0.9%.

What FDG POZYTON looks like and contents of the pack

FDG POZYTON is a clear, colorless or slightly yellow solution for injection.
One vial contains from 1 to 13 mL of solution, which corresponds to 3000 MBq - 39,000 MBq at calibration time per vial.
16.5 mL vial made of colorless glass type I, closed with a chlorobutyl rubber stopper and aluminum seal, in a lead shield container.

Marketing authorization holder and manufacturer

CENTRUM ONKOLOGII IM. PROF. FRANCISZKA ŁUKASZCZYKA W BYDGOSZCZY
ul. Dr I. Romanowskiej 2
85-796 Bydgoszcz
tel: +48 52 374 30 00

Date of last revision of the leaflet: