Package leaflet: Information for the user

FDG POZYTON, 3000 MBq/mL for calibration purposes, solution for injection
Fludeoxyglucosum ( F)
Please read all of this leaflet before the radiopharmaceutical is administered,
as it contains important information for the patient.

Keep this leaflet, so that you can read it again if necessary.
If you have any questions, please consult your doctor or nurse.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse immediately. See section 4.

Contents of the leaflet:

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

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

This product is intended for diagnostic use only.
FDG POZYTON contains the radioactive substance fludeoxyglucose (F) as a solution for injection. FDG POZYTON is used for a diagnostic imaging procedure known as positron emission tomography (PET) to visualize specific parts of the body.
After intravenous administration, FDG POZYTON enables the generation of images that provide the physician with additional information about the disease and its extent.

2. Important information before using FDG POZYTON

When not to use FDG POZYTON:

if the patient is allergic to fluorodeoxyglucose (F) or to any of the other components of this medicinal product FDG POZYTON (listed in section 6).

Warnings and precautions
Before administration of FDG POZYTON, consult a nuclear medicine physician:

if the patient has diabetes or if diabetes is currently uncontrolled
if the patient has an infection or inflammatory disease
if the patient has impaired kidney function

Inform the nuclear medicine physician in the following cases:

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

Before administration of FDG POZYTON

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

Children and adolescents
Inform the physician in the case of patients under 18 years of age.
FDG POZYTON and other medicines
Inform the physician about all medicines currently taken or recently taken (including medicines purchased without a prescription), as they may affect the interpretation of results from the examination using FDG POZYTON.
Examples of such medicines include:

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

FDG POZYTON with food and drink
Drink plenty of water and avoid drinking fluids containing sugar.
FDG POZYTON is administered only to patients who have not consumed food for at least 4 hours prior to administration.
Blood glucose concentration should be measured before administration of the medicinal product, since high blood sugar levels (hyperglycemia) may interfere with the interpretation of examination results.
Pregnancy, breastfeeding and effects on fertility
A patient who is breastfeeding or pregnant, suspects she may be pregnant, or has a delayed menstrual period, must consult a physician before administration of FDG POZYTON.
If the patient is pregnant
The physician will administer this medicinal product only if the benefits outweigh the potential risks or will consider this examination only if absolutely necessary.
If the patient is breastfeeding
If FDG POZYTON is administered during breastfeeding, breastfeeding must be interrupted for 12 hours after injection and milk expressed during this period must be discarded. Consult the physician to determine when breastfeeding can be resumed.
Fertility
No studies have been conducted on the effects of FDG POZYTON on fertility.
Driving and operating machinery
The effect of FDG POZYTON on the ability to drive and operate machinery is unlikely.
FDG POZYTON contains sodium
This medicinal product contains 3.54 mg of sodium (the main component of table salt) per millilitre. This corresponds to 0.2% of the maximum recommended daily dietary intake of sodium 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 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 injection of 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 providing the required information about the disease. FDG POZYTON
will be administered as an intravenous injection. The usual recommended dose for adults ranges from 100 to 400 MBq (megabecquerel – a unit of measurement of radioactive activity).
Use in children and adolescents
When FDG POZYTON is used in children and adolescents, the dose will be adjusted according to the patient's body weight.
Injection of FDG POZYTON and procedure
FDG POZYTON is administered intravenously. A single injection is sufficient for the examination. After the injection, the patient will be asked to drink a large amount of fluids that do not contain sugar and will be informed about the need to urinate frequently.
After administration, physical exertion should be avoided. The patient should lie down 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 FDG POZYTON injection, the patient should:

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

The doctor will inform the patient if additional precautions are necessary.
If you have any questions, please consult your doctor.
Use of a higher than recommended dose of FDG POZYTON
Overdose is almost impossible, as the patient receives a single diagnostic dose, 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 FDG POZYTON from the body.
If you have any further questions about the use of FDG POZYTON, please consult your doctor or a nuclear medicine specialist.

4. Possible adverse reactions

Like any medicine, this medicinal product may cause adverse reactions, although not everyone experiences them.
The FDG POZYTON medicinal product contains a small amount of radioactive substance which will be administered to the body, entailing a risk of developing tumours and congenital abnormalities.
If any adverse reactions occur, consult a nuclear medicine specialist physician.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. 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, 02-222 Warsaw, phone: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions contributes to the further accumulation of safety information regarding the use of this medicinal product.

5. How to store FDG POZYTON

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

6. Contents of the pack and other information

What FDG POZYTON contains

The active substance is fludeoxyglucose (F). Each ml of injection solution contains fludeoxyglucose (F) with an activity of 3000 MBq/mL at the time of calibration.
The other component is: sodium chloride 0.9%.

What FDG POZYTON looks like and contents of the pack
FDG POZYTON is a clear, colourless or slightly yellow injection solution.
One vial contains 1 to 13 mL of solution, corresponding to 3000 MBq – 39,000 MBq
at the time of calibration per vial.
16.5 mL vial made of colourless type I glass, closed with a chlorobutyl rubber stopper
and aluminium seal, placed in a lead shielding container.
Marketing Authorisation Holder and Manufacturer
CENTRUM ONKOLOGII IM. PROF. FRANCISZKA LUKASZCZYKA W BYDGOSZCZY
ul. Dr I. Romanowskiej 2
85-796 Bydgoszcz
tel: +48 52 374 30 00