Fludeoxyglucose (18f) ujv

Package leaflet: Information for the patient

FLUDEOXYGLUCOSE (18F) UJV, 100 – 1 500 MBq/mL
Solution for injection
fludeoxyglucose (18F)
Please read all of this leaflet carefully before receiving this medicine, because it contains
important information for you.

• Keep this leaflet so that you can read it again if needed.
• If you have any questions, please consult the nuclear medicine physician supervising the procedure.
• If you experience any adverse reactions, including any possible adverse reactions not listed in this leaflet, inform the nuclear medicine physician immediately. See section 4.

Table of contents:

1. What FLUDEOXYGLUCOSE (18F) UJV is and what it is used for
2. Important information before receiving 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 FLUDEOXYGLUCOSE (18F) UJV is and what it is used for

This medicine is a radiopharmaceutical intended solely for diagnostic use.
The active substance in FLUDEOXYGLUCOSE (18F) UJV is fludeoxyglucose (18F).
This medicine is used to perform diagnostic imaging of body tissues in patients.
After injection of a small amount of FLUDEOXYGLUCOSE (18F) UJV, images obtained during the scan using a special camera will help the physician locate disease or assess its progression.
Use of FLUDEOXYGLUCOSE (18F) UJV results in exposure to small doses of radiation. Your attending physician and the nuclear medicine physician have determined that the clinical benefits of using this radiopharmaceutical outweigh the risks associated with radiation exposure.

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

When not to use FLUDEOXYGLUCOSE (18F) UJV

• if the patient has hypersensitivity to fludeoxyglucose (18F) or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Before administration of FLUDEOXYGLUCOSE (18F) UJV, consult a physician if:

• the patient has diabetes and the condition is currently not well-controlled
• if the patient has an infection or inflammatory disease
• if the patient has recently undergone surgery, chemotherapy, or radiotherapy
• if the patient has kidney disease

Inform the physician in the following cases:

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

Before administration of FLUDEOXYGLUCOSE (18F) UJV, the patient should:

• drink plenty of water before the examination begins, so as to urinate as frequently as possible during the first hours after the examination
• avoid physical exertion
• remain fasting for at least 4 hours

Children and adolescents
If the patient is under 18 years of age, inform the physician.
FLUDEOXYGLUCOSE (18F) UJV and other medicines
Inform the nuclear medicine physician about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take, because they may affect the interpretation of imaging results:

• all medicines that may alter blood glucose levels (glycaemia), such as anti-inflammatory drugs (e.g. corticosteroids), anticonvulsants (e.g. valproic acid, carbamazepine, phenytoin, phenobarbital), or drugs affecting the nervous system (e.g. adrenaline, noradrenaline, dopamine, etc.),
• glucose,
• insulin,
• medicines used to stimulate blood cell production.

FLUDEOXYGLUCOSE (18F) UJV with food and drink
The patient should remain fasting for at least 4 hours before administration of the medicine.
The patient should drink large amounts of water and avoid drinking sugary beverages.
The physician will measure blood glucose levels before administering the medicine.
High blood glucose levels (hyperglycaemia) may interfere with the interpretation of imaging results.
Pregnancy and breastfeeding
Before administration of FLUDEOXYGLUCOSE (18F) UJV, inform the physician if the patient might be pregnant, if her menstrual period is delayed, or if she is breastfeeding.
In case of doubt, consult the physician performing the examination.
Pregnancy
The physician will consider performing this examination in a pregnant patient only if absolutely necessary, when expected benefits outweigh potential risks.
Breastfeeding
The patient must interrupt breastfeeding for 12 hours after injection of the medicine. Breast milk expressed during this period should be discarded.
Resumption of breastfeeding should be discussed with the physician supervising the examination.
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a nuclear medicine physician before administration of this medicine.
Driving and using machines
It is unlikely that FLUDEOXYGLUCOSE (18F) UJV will affect the ability to drive or operate machinery.
FLUDEOXYGLUCOSE (18F) UJV contains ethanol
This medicine contains a small amount 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 account if the patient is on a low-sodium diet.

3. How to use FLUDEOXYGLUCOSE (18F) UJV

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. FLUDEOXYGLUCOSE (18F) UJV will only be administered in authorized medical facilities. The preparation and administration of this medicinal product may only be carried out by personnel with appropriate training and qualifications in ensuring the safe use of this medicinal product. These individuals will ensure that the medicinal product is used safely and will inform the patient how the medicinal product is administered.

The physician supervising the procedure will determine the appropriate dose of FLUDEOXYGLUCOSE (18F) UJV for the patient. This will be the smallest amount necessary to obtain the required diagnostic information. The usual recommended dose for an adult is 100 to 400 MBq (depending on the patient's body weight, the type of imaging camera used, and the mode of administration).

The megabecquerel (MBq) is a unit of measurement for radioactivity in the metric system.

Use in children and adolescents
The amount of medicinal product administered to children and adolescents will depend on the patient's body weight.

Administration of FLUDEOXYGLUCOSE (18F) UJV and performance of the scan
FLUDEOXYGLUCOSE (18F) UJV is administered intravenously.
A single injection is sufficient for performing the scan ordered by the physician.
After the injection, the patient should rest in a comfortable position and must not read or talk. After administration of the medicinal product, the patient will be asked to drink water and, immediately before the start of the scan, to empty the bladder.

Duration of the scan
The physician will inform the patient of the exact duration of the scan. FLUDEOXYGLUCOSE (18F) UJV is administered as a single intravenous injection 45 to 60 minutes before the start of the scan. The imaging procedure using the camera usually lasts between 30 and 60 minutes.

After administration of FLUDEOXYGLUCOSE (18F) UJV, the patient should:

• avoid close contact with young children and pregnant women for 12 hours after injection
• urinate frequently to help eliminate the medicinal product from the body

Administration of a higher than recommended dose of FLUDEOXYGLUCOSE (18F) UJV
Overdose is unlikely because the patient receives only a single dose of FLUDEOXYGLUCOSE (18F) UJV, carefully prepared under the supervision of the physician performing the procedure. However, in the event of an overdose, the physician will initiate appropriate treatment. The supervising physician may recommend drinking large amounts of fluids, which will facilitate the elimination of FLUDEOXYGLUCOSE (18F) UJV from the body (the primary route of elimination of this medicinal product is via urine).

If you have any further questions regarding the use of this medicinal product, please consult your nuclear medicine physician who is supervising the procedure.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
This medicine involves exposure to a small dose of ionizing radiation, which carries a very low risk of cancer induction and congenital abnormalities.
Your doctor has assessed that the benefits of using this medicine outweigh the risks associated with exposure to ionizing radiation.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, please consult your nuclear medicine physician for advice. 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
Tel.: +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 marketing authorization holder.
Reporting adverse reactions enables further information on the safety of the medicine to be collected.

5. How to store FLUDEOXYGLUCOSE (18F) UJV

The patient will not have to store this medicine. The medicine is stored at an appropriate
medical facility under the supervision of a specialist. Radiopharmaceuticals must be
stored in accordance with national regulations concerning radioactive materials.
The following information is intended exclusively for medical professionals.
Do not use the medicine after the expiry date stated on the label following expiry (EXP).
The product must not be used if a possible damage to the vial is observed.

6. Package contents and other information

What FLUDEOXYGLUCOSE (18F) UJV contains

• The active substance is fludeoxyglucose (18F).

• 1 ml of injection solution contains 100 - 1,500 MBq of fludeoxyglucose (18F) at the date and time of calibration.

• Other ingredients: 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 container ranges from 500 MBq to 30,000 MBq at the date and time of calibration.
Immediate packaging
Multidose vial with a capacity of 10 or 20 ml, closed with a bromobutyl rubber stopper in graphite colour, secured with an aluminium seal and a polyethylene (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 can (for P 30 containers), steel cassette (for HU GP-40 containers); for other containers, depending on their design.
Marketing Authorisation Holder:
ÚJV Řež, a.s., Hlavní 130, Řež, 250 68 Husinec, Czech Republic
Telephone number: +420 266 172 269, e-mail: [email protected]
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 authorised in the Member States of the European Economic Area under the following names:
Austria, Czech Republic, Germany, Poland: Fludeoxyglucose (18F) UJV
The following information is intended exclusively for medical professionals:
The full Product Information for FLUDEOXYGLUCOSE (18F) UJV is provided as a separate document within the medicinal product documentation package. Its purpose is to provide medical professionals with additional scientific and practical information regarding the administration and use of this radiopharmaceutical product.
Please read the Product Information carefully (the Product Information should be included in the packaging).