Natrii fluoridum (18f) Sinektik

Leaflet attached to the packaging: patient information

Sodium fluoride (F) Synektik 2.0 GBq/mL, solution for injection

Sodium fluoride (F)

Please read the contents of the leaflet carefully before receiving the medicine, as it contains important information for the patient.

• Please keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, please consult the nuclear medicine doctor who will supervise the examination.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in the leaflet, please inform the nuclear medicine doctor who supervised the examination. See section 4.

Table of contents of the leaflet:

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

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

Sodium fluoride (F) Synektik contains the active substance sodium fluoride (F).
This is a radiopharmaceutical product (radioactive medicine) intended exclusively for diagnostic purposes.
Sodium fluoride (F) Synektik is used for diagnostic purposes during examinations performed using positron emission tomography (PET) and is administered before the start of such an examination.
The radioactive substance from Sodium fluoride (F) Synektik (showing bone metabolism) is detected in the PET examination and is visible on the obtained images.
Positron emission tomography is an imaging method used in nuclear medicine that allows for the acquisition of cross-sectional images of living organisms. To perform it, a very small amount of radioactive pharmaceutical product is sufficient to obtain quantitative and accurate images reflecting specific metabolic processes in the body. The examination is performed to determine the treatment of a disease that has been detected or is suspected in the patient.
Administration of Sodium fluoride (F) Synektik involves exposing the patient to a small amount of radiation. The examination using a radiopharmaceutical product is performed only when the nuclear medicine doctor considers that the benefits to the patient resulting from the examination outweigh the risk associated with exposure to radiation.

2. Important information before administering Sodium fluoride (F) Synektik

Sodium fluoride (F) Synektik must not be administered

• if the patient is allergic (hypersensitive) to sodium fluoride (F) or any of the other components of this medicine (listed in section 6);
• if the patient is pregnant or suspects that she is pregnant, she should inform the nuclear medicine doctor.

Warnings and precautions

When using Sodium fluoride (F) Synektik, special caution should be exercised.
Before administering Sodium fluoride (F) Synektik, the patient should inform the nuclear medicine doctor supervising the examination if:

• the patient is pregnant or suspects that she may be pregnant;
• the patient is breastfeeding;
• there are kidney function disorders.

Before receiving Sodium fluoride (F) Synektik, the patient should

• drink plenty of water, so that at the time of the examination, they are well-hydrated and can urinate frequently during the first few hours after the examination.

Children and adolescents

If the patient is under 18 years of age, they should talk to the nuclear medicine doctor to whom they have been referred.

Sodium fluoride (F) Synektik and other medicines

The patient should tell the nuclear medicine doctor who will perform the examination about all medicines currently being taken or recently taken, including those taken without a prescription, as they may interfere with the interpretation of the images obtained.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult the nuclear medicine doctor before receiving this medicine.

Pregnancy

If the patient is pregnant, Sodium fluoride (F) Synektik must not be administered.
Before receiving Sodium fluoride (F) Synektik, the patient must inform the nuclear medicine doctor about possible pregnancy or delayed menstruation.
In case of any doubts, the patient should consult the nuclear medicine doctor who will supervise the examination.
If the patient is breastfeeding, she can express milk and store it for later use before the injection. Breastfeeding should be interrupted for at least 12 hours. The expressed milk during this time should be discarded.
The patient should ask the nuclear medicine doctor when she can resume breastfeeding.
It is recommended to avoid close contact with infants for 12 hours after the injection.

Driving and operating machinery

The effect of Sodium fluoride (F) Synektik on the ability to drive and operate machinery is considered unlikely.

Sodium fluoride (F) Synektik contains sodium

This medicine may contain more than 1 mmol of sodium (up to 23 mg per dose), which should be taken into account in patients controlling their sodium intake.

3. How to use Sodium fluoride (F) Synektik

The use of radiopharmaceutical products, handling, and disposal are strictly regulated by relevant regulations. Sodium fluoride (F) Synektik is used exclusively in hospital settings. Only properly trained and qualified personnel will handle and administer it to the patient. These personnel will take special care to ensure that the product is used safely and will inform the patient about the procedures being performed.
The nuclear medicine doctor supervising the examination will decide what dose of Sodium fluoride (F) Synektik to administer to the patient. This will be the smallest dose necessary to obtain the necessary information.
The recommended dose for adults is 100 to 400 MBq. Megabecquerel (MBq) is a unit of measurement of radioactivity.

Use in children and adolescents

In children and adolescents, the administered dose will be adjusted according to body weight.

Administration of Sodium fluoride (F) Synektik and the course of the examination

Sodium fluoride (F) Synektik is administered as a single intravenous injection.

Duration of the examination

The nuclear medicine doctor supervising the examination will inform the patient how long it usually takes.
The PET examination is usually performed within 60 minutes to 3 hours after the injection, depending on the type of procedure. After the injection, the patient will be given water to drink and will be asked to empty their bladder immediately before the start of the examination.

After receiving Sodium fluoride (F) Synektik, the patient should

• avoid close contact with small children and pregnant women for 12 hours after the injection;
• urinate frequently to remove the administered product from the body;
• avoid contact with infants for 12 hours after the injection.

The nuclear medicine doctor will inform the patient if any special precautions are necessary after receiving this medicine.
In case of any questions, please contact the nuclear medicine doctor.

Overdose of Sodium fluoride (F) Synektik

Overdose is almost impossible, as the patient will receive only one dose of Sodium fluoride (F) Synektik, precisely checked by the nuclear medicine doctor supervising the examination. If an overdose occurs, the patient will receive appropriate treatment.
Removal of the radioactive substance from the body should be maximally accelerated. The patient should drink as much as possible and urinate as frequently as possible. It may be necessary to take diuretic medicines.
In case of any further questions about the use of Sodium fluoride (F) Synektik, please consult the nuclear medicine doctor supervising the examination.

4. Possible side effects

Like all medicines, Sodium fluoride (F) Synektik can cause side effects, although not everybody gets them.
No serious side effects have been reported so far.
This radiopharmaceutical product will emit a small amount of ionizing radiation after administration, which is associated with a very low risk of later development of malignant tumors and congenital defects in offspring.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, please inform the nuclear medicine doctor who supervised the examination.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +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.
By reporting side effects, more information can be collected on the safety of this medicine.

5. How to store Sodium fluoride (F) Synektik

The patient will not need to store this product. The specialist is responsible for storing this medicine in the appropriate place.
Radiopharmaceutical products are stored in accordance with national regulations regarding radioactive materials.
The following information is intended only for specialists.
Sodium fluoride (F) Synektik must not be used after the expiry date stated on the label.

6. Package contents and other information

What Sodium fluoride (F) Synektik contains

• The active substance is sodium fluoride (F). One mL of the solution contains sodium fluoride (F) with an activity of 2.0 GBq on the day and hour of calibration.
• The other ingredients are water for injection, sodium chloride, and potassium dihydrogen phosphate.

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

A colorless solution in a 15 mL or 25 mL multidose vial
The total activity of the vial on the day and hour of calibration is between 0.4 GBq and 44 GBq.

Marketing authorization holder

SYNEKTIK S.A.

ul. Józefa Piusa Dziekońskiego 3
00-728 Warsaw
Poland

Manufacturer

Synektik Pharma Sp. z o.o.

ul. Artwińskiego 3
25-734 Kielce
Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland

Sodium fluoride (F) Synektik

Lithuania

Sodium fluoride (F) Synektik 2.0 GBq/mL, injection solution

Slovak Republic

METAFLU 2.0 GBq/mL, injection solution

Date of last revision of the leaflet: 18.09.2024

Other sources of information

Detailed information about this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://www.urpl.gov.pl
Information intended only for healthcare professionals:
The full text of the Summary of Product Characteristics of Sodium fluoride (F) Synektik is provided as a separate document in the product packaging, to provide healthcare professionals with additional scientific and practical information about the administration and use of this radiopharmaceutical.
Please read the Summary of Product Characteristics.