Fludeoxiglucose (18f) Uiv

Package Leaflet: Information for the Patient

FLUDEOXYGLUCOSE (18F) UJV, 100 – 1 500 MBq/mL

Solution for injection
fludeoxyglucose (18F)

Read the package leaflet carefully before receiving this medicine, as it contains important information for you.

• Keep this package leaflet, you may need to read it again.
• In case of any doubts, consult your nuclear medicine doctor who supervises the procedure.
• If you experience any side effects, including any possible side effects not listed in this leaflet, tell your nuclear medicine doctor. See section 4.

Table of Contents of the Package Leaflet:

• 1. What is FLUDEOXYGLUCOSE (18F) UJV and what is it used for
• 2. Important information before using FLUDEOXYGLUCOSE (18F) UJV
• 3. How to use FLUDEOXYGLUCOSE (18F) UJV
• 4. Possible side effects
• 5. How to store FLUDEOXYGLUCOSE (18F) UJV
• 6. Contents of the pack and other information

1. What is FLUDEOXYGLUCOSE (18F) UJV and what is it used for

This medicine is a radiopharmaceutical preparation intended solely for diagnostic purposes.
F).
The medicine is intended for performing diagnostic imaging examinations of parts of the patient's body.
After injecting a small amount of FLUDEOXYGLUCOSE (18F) UJV, the images obtained during the examination using a special camera will help the doctor locate the disease or assess its progression.
The use of FLUDEOXYGLUCOSE (18F) UJV results in exposure to small doses of radiation. The attending physician and the nuclear medicine doctor have assessed that the clinical benefits associated with the use of the radiopharmaceutical product outweigh the risk of radiation exposure.
The active substance contained in FLUDEOXYGLUCOSE (18F) UJV is fludeoxyglucose (

2. Important information before using FLUDEOXYGLUCOSE (18F) UJV

When not to use FLUDEOXYGLUCOSE (18F) UJV

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

Warnings and precautions

Before administering FLUDEOXYGLUCOSE (18F) UJV, consult your doctor if:

• the patient has diabetes and it is not currently controlled
• the patient has an infection or inflammatory disease
• the patient has recently undergone surgery, chemotherapy, or radiotherapy;
• the patient has kidney disease

Tell your doctor:

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

Before administering FLUDEOXYGLUCOSE (18F) UJV:

• drink plenty of water before the examination, so that you urinate as much as possible in the first hours after the examination
• avoid physical exertion
• fast for at least 4 hours

Children and adolescents

If the patient is under 18 years old, tell your doctor.

FLUDEOXYGLUCOSE (18F) UJV and other medicines

Tell your nuclear medicine doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, as they may affect the interpretation of the imaging results:

• all medicines that may change blood sugar levels (glycemia), such as anti-inflammatory medicines (e.g., corticosteroids), antiepileptic medicines (e.g., valproic acid, carbamazepine, phenytoin, phenobarbital), medicines affecting the nervous system (e.g., adrenaline, noradrenaline, dopamine, etc.),
• glucose,
• insulin,
• medicines used to increase blood cell production.

FLUDEOXYGLUCOSE (18F) UJV with food and drink

The patient should fast for at least 4 hours before administration of the medicine.
The patient should drink plenty of water and avoid drinking sugary beverages.
The doctor will measure the patient's blood sugar level before administering the medicine;
High blood sugar levels (hyperglycemia) may make it difficult to interpret the examination results.

Pregnancy and breastfeeding

Before administering FLUDEOXYGLUCOSE (18F) UJV, tell your doctor if the patient may be pregnant, if the patient's menstrual period is delayed, or if the patient is breastfeeding.
In case of doubts, consult the doctor performing the examination.
Pregnancy
The doctor will consider performing this examination on a pregnant patient only if absolutely necessary, when the expected benefits outweigh the potential risk.
Breastfeeding
The patient must stop breastfeeding for 12 hours after injection of the medicine, and the breast milk expressed during this time should be discarded.
Resuming breastfeeding should be discussed with the doctor supervising the examination.
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to have a child, she should consult her nuclear medicine doctor before receiving this medicine.

Driving and using machines

It is unlikely that FLUDEOXYGLUCOSE (18F) UJV will affect the patient's ability to drive or operate machines.

FLUDEOXYGLUCOSE (18F) UJV contains ethanol

This medicine contains small amounts of ethanol (alcohol), less than 100 mg per dose

FLUDEOXYGLUCOSE (18F) UJV contains sodium

This medicine may contain more than 1 mmol of sodium (23 mg). This should be taken into consideration if the patient is on a low-sodium diet.

3. How to use FLUDEOXYGLUCOSE (18F) UJV

There are strict regulations regarding the use of radiopharmaceutical preparations, their handling, and disposal. FLUDEOXYGLUCOSE (18F) UJV will only be used in authorized medical facilities. The medicine can only be prepared and administered by persons with appropriate training and qualifications in the safe use of this medicine. These persons will ensure that the medicine is used safely and will inform the patient how the medicine is administered.
The doctor supervising the examination will select the appropriate dose of FLUDEOXYGLUCOSE (18F) UJV for the patient. This will be the smallest amount necessary to obtain the required information.
Usually, the recommended dose for an adult is between 100 and 400 MBq (depending on the patient's body weight, the type of camera used for imaging, and the administration mode).
Megabecquerel (MBq) is a unit of measurement of radioactivity in the metric system.

Use in children and adolescents

The amount of medicine given to children and adolescents will depend on the patient's body weight.

Administration of FLUDEOXYGLUCOSE (18F) UJV and performance of the examination

FLUDEOXYGLUCOSE (18F) UJV is administered intravenously.
A single injection is sufficient to perform the examination ordered by the doctor.
After injection, the patient should rest in a comfortable position, without reading or talking. After injection of the medicine, the patient will be asked to drink water and then, immediately before the start of the examination, to urinate.

Duration of the examination

The doctor will inform you about the exact duration of the examination. FLUDEOXYGLUCOSE (18F) UJV is administered in a single intravenous injection, 45-60 minutes before the start of the examination.
The examination using the imaging camera usually takes from 30 to 60 minutes.

After administration of FLUDEOXYGLUCOSE (18F) UJV:

• avoid close contact with small children and pregnant women for 12 hours after injection
• urinate frequently to remove the medicine from the body

Overdose of FLUDEOXYGLUCOSE (18F) UJV

Overdose is unlikely, as the patient receives only one dose of FLUDEOXYGLUCOSE (18F) UJV, carefully prepared under the control of the doctor performing the examination. However, in case of overdose, the doctor will initiate appropriate treatment. The doctor supervising the procedure may recommend drinking plenty of fluids, which will facilitate the removal of FLUDEOXYGLUCOSE (18F) UJV from the body (the primary way of removing this medicine from the body is through urine).
In case of any other questions related to the use of this medicine, consult your nuclear medicine doctor who supervises the procedure.

4. Possible side effects

Like all medicines, this medicine may cause side effects, although not everybody gets them.
Together with this medicine, a small dose of ionizing radiation is administered, which carries a very small risk of developing cancer and congenital anomalies.
The attending physician has assessed that the benefits associated with the use of this medicine outweigh the risk of exposure to ionizing radiation.

Reporting side effects

If you experience any side effects, including any possible side effects not listed in this leaflet, consult your nuclear medicine doctor. Side effects can be reported directly to the Department of Pharmacovigilance of the 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.
Reporting side effects will allow for the collection of more information on the safety of this medicine.

5. How to store FLUDEOXYGLUCOSE (18F) UJV

The patient will not need to store this medicine. The medicine is stored in an appropriate medical facility under the supervision of a specialist. Radiopharmaceutical preparations should be stored in accordance with national regulations regarding radioactive materials.
The following information is intended for healthcare professionals only.
Do not use the medicine after the expiry date stated on the label after the expiry date (EXP).
The product should not be used if damage to the vial is detected.

6. Contents of the pack and other information

What FLUDEOXYGLUCOSE (18F) UJV contains

• The active substance of the medicine is fludeoxyglucose (18F).
• 1 ml of the solution for injection contains 100 - 1 500 MBq of fludeoxyglucose (F) on the day and

hour of calibration.

• The other ingredients are: sodium chloride, water for injections, anhydrous ethanol, disodium hydrogen citrate (for pH adjustment), sodium citrate (for pH adjustment).

What FLUDEOXYGLUCOSE (18F) UJV looks like and contents of the pack

The activity of the solution in the pack is between 500 MBq and 30 000 MBq on the day and hour of calibration.

Immediate packaging

A 10 or 20 ml multidose vial, closed with a gray bromobutyl rubber stopper, sealed with an aluminum cap and a PE cap.

Outer packaging:

Lead container type P 30, container HU GP-40, or other packaging approved for the transport of radioactive substances.
Protective transport packaging: sealed metal box (for P 30 containers), steel cassette (for HU GP-40 containers); for other containers, depending on their design.

Marketing authorization holder:

ÚJV Řež, a.s., Hlavní 130, Řež, 250 68 Husinec, Czech Republic
Phone number: +420 266 172 269, e-mail: radiofarmaka@ujv.cz

Manufacturer:

ÚJV Řež, a. s., Hlavní 130, Řež, 250 68 Husinec, Czech Republic
ÚJV Řež, a. s., Nemocnice Na Homolce, Roentgenova 2, 150 00 Prague 5, Czech Republic
ÚJV Řež, a. s., Masarykův onkologický ústav, Žlutý kopec 7a, 656 53 Brno, Czech Republic

This product has been approved in the Member States of the European Economic Area under the following names:

The following information is intended for healthcare professionals only:

The full Summary of Product Characteristics of FLUDEOXYGLUCOSE (18F) UJV is provided as a separate document in the package of the medicinal product documentation. Its purpose is to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical product.
Read the Summary of Product Characteristics (the Summary of Product Characteristics should be included in the packaging).