Fludeoxiglucose (18f) Sinektik

Leaflet attached to the packaging: information for the user

Fludeoxyglucose (F) Synektik

200-2200 MBq/ml, solution for injection

Fludeoxyglucose (F)

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, you should ask your nuclear medicine specialist, who will be supervising the examination.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform the nuclear medicine specialist who supervised the examination.

Table of contents of the leaflet:

• 1. What is Fludeoxyglucose (F) Synektik and what is it used for
• 2. Important information before using Fludeoxyglucose (F) Synektik
• 3. How to use Fludeoxyglucose (F) Synektik
• 4. Possible side effects
• 5. How to store Fludeoxyglucose (F) Synektik
• 6. Package contents and other information.

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

Fludeoxyglucose (F) Synektik is a radiopharmaceutical product, intended exclusively for diagnostic purposes.
The active substance contained in Fludeoxyglucose (F) Synektik is fludeoxyglucose (F), which is intended for producing radiographic images of certain parts of the body.
After administering a small amount of Fludeoxyglucose (F) Synektik into a vein, an appropriate scanner will allow the doctor to produce images and determine the location or development of the disease.

2. Important information before using Fludeoxyglucose (F) Synektik

When not to use Fludeoxyglucose (F) Synektik:

• -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 starting the administration of Fludeoxyglucose (F) Synektik, you should discuss it with your 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.

You should inform your nuclear medicine specialist if:

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

Before administering Fludeoxyglucose (F) Synektik, you should:

• drink plenty of water before starting the examination, in order to frequently urinate during the first hours after the examination,
• avoid physical exertion,
• fast for at least 4 hours.

Children and adolescents

You should talk to your nuclear medicine specialist if the patient is under 18 years old.

Fludeoxyglucose (F) Synektik and other medicines

You should tell your 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, as they may affect the interpretation of the examination results.

• all medicines that may cause changes in blood glucose levels, such as: medicines used in inflammatory diseases (corticosteroids), medicines used in the treatment of seizures (valproic acid, carbamazepine, phenytoin, phenobarbital), medicines that affect the nervous system (adrenaline, noradrenaline, dopamine, etc.),
• glucose,
• insulin,
• medicines containing factors that increase blood cell production.

Fludeoxyglucose (F) Synektik with food and drink

You should not eat for at least 4 hours before administering the medicine. Before the examination, the patient should drink plenty of water and avoid consuming sugary drinks.
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 doctor to interpret the examination results.

Pregnancy and breastfeeding

If the patient suspects she may be pregnant or if she is breastfeeding, she must inform her nuclear medicine specialist before administering Fludeoxyglucose (F) Synektik.
In case of doubts, you should consult your nuclear medicine specialist, who will be supervising the examination.

If the patient is pregnant

The nuclear medicine specialist will administer this medicine to a pregnant patient only if the expected benefits to the mother outweigh the potential risk to the fetus.

If the patient is breastfeeding

Breastfeeding should be interrupted for 12 hours after injecting the medicine, and the expressed milk during this period should be discarded.
Resuming breastfeeding must be agreed upon with the nuclear medicine specialist, who will be supervising the examination.

Driving and using machines

The effect of Fludeoxyglucose (F) Synektik on the ability to drive and use machines is unlikely.

Fludeoxyglucose (F) Synektik contains sodium

The medicine contains more than 1 mmol (23 mg) of sodium per dose, which should be taken into account in patients controlling their sodium intake.

3. How to use Fludeoxyglucose (F) Synektik

There are strict rules and regulations regarding the use, handling, and disposal of radiopharmaceutical products. Fludeoxyglucose (F) Synektik will be administered in specially protected rooms. This medicine will be used and administered by trained and qualified personnel to ensure safety. These personnel will take special care to ensure the safe use of this medicine and will keep the patient informed about what they are doing.
The nuclear medicine specialist supervising the examination will determine the amount of Fludeoxyglucose (F) Synektik to be used for diagnostic purposes. This will be the smallest amount necessary to obtain the required information.
For an adult, the recommended activity for administration is usually 100-400 MBq (depending on the patient's body weight and the type of scanner used for imaging, as well as the method of image acquisition).
Megabecquerel (MBq) is a unit of measurement of radioactivity in the metric system.

Use in children and adolescents

In the case of use in children and adolescents, the administered amount of the medicine will be adjusted according to the child's body weight.

Administration of Fludeoxyglucose (F) Synektik and performance of the procedure

Fludeoxyglucose (F) Synektik is administered intravenously.
A single injection is sufficient to perform the examination required by the doctor.
After injection, the patient should remain completely at rest, in a comfortable position, without reading or talking. The patient will also be given drinks and asked to empty their bladder immediately before the examination.
During the examination, the patient must remain completely at rest. They should not move or talk.

Duration of the procedure

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

After injecting Fludeoxyglucose (F) Synektik, you should:

• avoid contact with small children and pregnant women for 12 hours after injecting the medicine,
• frequently urinate to eliminate the medicine from the body.

Use of a higher than recommended dose of Fludeoxyglucose (F) Synektik

Overdose is practically impossible, as Fludeoxyglucose (F) Synektik is administered in a single dose, carefully checked and prepared by the nuclear medicine specialist supervising the examination. However, in the event of an overdose, appropriate treatment will be implemented. In particular, the nuclear medicine specialist supervising the examination will recommend drinking plenty of fluids to facilitate the elimination of Fludeoxyglucose (F) Synektik from the body (this medicine is mainly excreted by the kidneys, in the urine). In case of any further doubts regarding the use of Fludeoxyglucose (F) Synektik, you should consult your nuclear medicine specialist.

4. Possible side effects

Like all medicines, Fludeoxyglucose (F) Synektik can cause side effects, although not everybody gets them.
After administration, this radiopharmaceutical product will emit a small dose of ionizing radiation, which is associated with a very low risk of developing cancer and/or genetic disorders.
The doctor, ordering such an examination, has considered that the therapeutic benefits for the patient, obtained through the examination using the radiopharmaceutical, outweigh the risk associated with radiation exposure.
If any side effects occur, including any side effects not listed in this leaflet, you should inform your nuclear medicine specialist.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, you should inform 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
By reporting side effects, you can help gather more information on the safety of the product.

5. How to store Fludeoxyglucose (F) Synektik

This medicine will not be available to the patient for storage. The storage of this medicine in appropriate conditions is the responsibility of trained medical personnel.
The following information is intended exclusively for medical professionals.
Do not use this medicinal product after the expiry date stated on the label.

6. Package contents and other information

What Fludeoxyglucose (F) Synektik contains

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

What Fludeoxyglucose (F) Synektik looks like and what the package contains

The activity contained in the vial is from 40 to 22000 MBq at the time of calibration.

Marketing authorization holder and manufacturer

Marketing authorization holder

Synektik Pharma Sp. z o.o.
ul. Józefa Piłsudskiego 3
00-728 Warsaw, Poland

Manufacturer

Synektik Pharma Sp. z o.o.
ul. Keramzytowa 16
96-320 Mszczonów
Tel.: +48 46 857 14 25/26/27
Fax: +48 857 14 28
Date of last revision of the leaflet:August 2021

Information intended exclusively for medical professionals

The full Summary of Product Characteristics of Fludeoxyglucose (F) Synektik is attached as a separate document to each package of the medicinal product. The Summary of Product Characteristics contains additional practical and scientific information for medical personnel, regarding the administration and handling of the radiopharmaceutical product.
You should read the Summary of Product Characteristics (attached to the packaging).