Fludeoxyglucose (18f) synektik

Package leaflet: Information for the user

Fludeoxyglucose ( F) Synektik
200-2200 MBq/ml, solution for injection
Fludeoxyglucosum ( F)
Please read all of this leaflet carefully before the medicine is administered, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please consult the nuclear medicine specialist who will supervise the examination.
• If you experience any adverse reactions, including any not listed in this leaflet, inform the nuclear medicine specialist who supervised the examination.

Leaflet contents:

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

1. What Fludeoxyglucose (F) Synektik is and what it is used for

Fludeoxyglucose (F) Synektik is a radiopharmaceutical product intended solely for diagnostic use.
The active substance contained in Fludeoxyglucose (F) Synektik is fludeoxyglucose (F), which is used for producing radiographic images of specific parts of the body.
After administering a small amount of Fludeoxyglucose (F) Synektik into a vein, a specialized scanner will enable the physician to obtain images and determine the location or extent of disease.

2. Important information before using Fludeoxyglucose (18F) Synektik

When not to use Fludeoxyglucose (18F) Synektik:

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

Warnings and precautions
Before starting administration of Fludeoxyglucose (18F) Synektik, discuss the following with the nuclear medicine specialist:

• if the patient has uncontrolled diabetes,
• if the patient has an infection or inflammatory disease,
• if the patient has impaired kidney function.

The patient should inform the nuclear medicine specialist if:

• the patient is pregnant or suspects she may be pregnant,
• the patient is breastfeeding.

Before administration of Fludeoxyglucose (18F) Synektik, the patient should:

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

Children and adolescents
Talk to the nuclear medicine specialist if the patient is under 18 years of age.

Fludeoxyglucose (18F) Synektik and other medicines
Tell the nuclear medicine specialist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, because they may affect the interpretation of the examination results.

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

Fludeoxyglucose (18F) Synektik with food and drink
The patient must not eat food for at least 4 hours before administration of the medicine. Before the examination, the patient should drink plenty of water and avoid consuming fluids containing sugar. The nuclear medicine specialist will measure the patient's glucose level before administering the medicine; high blood sugar levels (hyperglycemia) may make it difficult for the physician to interpret the examination results.

Pregnancy and breastfeeding
If the patient suspects she may be pregnant, if she has missed her period, or if she is breastfeeding, she must inform the nuclear medicine specialist before receiving Fludeoxyglucose (18F) Synektik.
In case of doubt, consult the nuclear medicine specialist supervising the examination.

If the patient is pregnant
The nuclear medicine specialist will administer this medicine during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.

If the patient is breastfeeding
Breastfeeding must be interrupted for 12 hours after injection of the medicine, and breast milk expressed during this period should be discarded.
Resuming breastfeeding should be discussed with the nuclear medicine specialist supervising the examination.

Driving and operating machinery
The effect of Fludeoxyglucose (18F) Synektik on the ability to drive and operate machinery is unlikely.

Fludeoxyglucose (18F) Synektik contains sodium
This medicine contains more than 1 mmol (23 mg) of sodium per dose, which should be taken into account in patients who are controlling their sodium intake in the diet.

3. How to use Fludeoxyglucose (18F) Synektik

There are strict rules and regulations regarding the use, handling, and disposal of radiopharmaceuticals. Fludeoxyglucose (18F) Synektik will be administered in specially shielded facilities. This medicinal product will be used and administered by trained and qualified personnel to ensure safety. These individuals will take particular care to ensure the safe use of this medicinal product and will keep the patient continuously informed about what is being done.

The nuclear medicine specialist supervising the examination will determine the amount of Fludeoxyglucose (18F) Synektik required for diagnostic use in each individual case. This will be the smallest amount necessary to obtain the required information.

For adults, the recommended activity to be administered is usually 100–400 MBq (depending on the patient's body weight, the type of imaging scanner used, and the imaging protocol).

The megabecquerel (MBq) is a metric unit of measurement of radioactivity.

Use in children and adolescents
When used in children and adolescents, the administered dose of the medicinal product will be adjusted according to the child's body weight.

Administration of Fludeoxyglucose (18F) Synektik and procedure
Fludeoxyglucose (18F) Synektik is administered intravenously.
A single injection is sufficient to perform the examination required by the physician.

After injection, the patient should remain completely at rest, in a comfortable position, without reading or talking. The patient will also be offered fluids and will be asked to empty the bladder immediately before the examination.

During the examination, the patient must remain completely still. Movement and talking should be avoided.

Duration of the procedure
The nuclear medicine specialist will inform the patient how long the examination usually takes. Fludeoxyglucose (18F) Synektik will be administered intravenously as a single injection, 45 to 60 minutes before the start of the imaging procedure. Image acquisition lasts from 30 to 60 minutes.

After injection of Fludeoxyglucose (18F) Synektik, the patient should:

• avoid 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) Synektik
Overdose is practically impossible, as a single dose of Fludeoxyglucose (18F) Synektik is administered, precisely measured and prepared by the nuclear medicine specialist supervising the examination. However, in the event of an overdose, appropriate treatment will be initiated. In particular, the nuclear medicine specialist conducting the examination will recommend drinking large amounts of fluids to enhance the elimination of Fludeoxyglucose (18F) Synektik from the body (this medicinal product is primarily excreted via the kidneys in urine).

If there are any further doubts regarding the use of Fludeoxyglucose (18F) Synektik, the patient should consult the nuclear medicine specialist.

4. Possible adverse reactions

Like all medicines, this product may cause adverse reactions, although not everyone will experience them.
After administration, this radiopharmaceutical will emit a small dose of ionising radiation, which is associated with a very low risk of developing cancer and (or) genetic defects.
The physician who ordered this examination has determined that the diagnostic benefits for the patient obtained through the use of a radiopharmaceutical outweigh the risks associated with radiation exposure.
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the nuclear medicine specialist physician.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the physician, 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 49 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions allows the collection of additional information on the safety of the product's use.

5. How to store Fludeoxyglucose (18F) Synektik

This medicinal product will not be available to the patient for storage. Trained medical personnel are responsible for storing this medicinal product under appropriate conditions.
The following information is intended exclusively for healthcare professionals.
Do not use this medicinal product after the expiry date stated on the label.

6. Contents of the package and other information

What Fludeoxyglucose (18F) Synektik contains

• The active substance is fludeoxyglucose (18F). 1 ml of injection solution contains fludeoxyglucose (18F) with an activity of 200 - 2200 MBq at the date and time of calibration.
• Other components are: sodium chloride, water for injections, disodium citrate and sodium citrate.

What Fludeoxyglucose (18F) Synektik looks like and contents of the pack
The activity contained in the vial ranges from 40 to 22000 MBq at the date and time of calibration.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Synektik Pharma Sp. z o.o.
Józefa Piusa Dzierżonia 3
00-728 Warsaw, Poland
Manufacturer
Synektik Pharma Sp. z o.o.
Keramzytowa 16
96-320 Mszczonów
Tel.: +48 46 857 14 25/26/27
Fax: +48 857 14 28

Information intended exclusively for medical professionals

The full Product Information for Fludeoxyglucose (18F) Synektik is attached
as a separate document to each product package. This document contains
additional practical and scientific information for medical personnel
regarding administration and handling of the radiopharmaceutical product.
Please consult the Product Information leaflet (included in the package).