SODIUM FLUORIDE (18F) SYNEKTIK

Package leaflet: Information for the patient

Natrii fluoridum ( F) Synektik 2.0 GBq/mL, solution for injection
Sodium fluoride ( F)
Please read all of this leaflet carefully before receiving the medicine, as it contains important
information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult the nuclear medicine physician who will supervise your examination.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform the nuclear medicine physician who supervised the examination. See section 4.

Leaflet contents:

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

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

Natrii fluoridum ( F) Synektik contains the active substance sodium fluoride ( F).
It is a radiopharmaceutical (radioactive medicinal product) intended solely for diagnostic purposes.
Natrii fluoridum ( F) Synektik is used for diagnostic purposes during positron emission tomography (PET) scans and is administered prior to such an examination.
The radioactive substance from Natrii fluoridum ( F) Synektik (indicating bone metabolism) is detected during the PET scan and appears on the resulting images.
Positron emission tomography is an imaging technique used in nuclear medicine that enables cross-sectional imaging of living organisms. Only a very small amount of the radioactive medicinal product is required to obtain quantitative and precise images reflecting specific metabolic processes in the body. This examination is performed to determine the appropriate treatment for a disease that has been detected or is suspected in the patient.
Administration of Natrii fluoridum ( F) Synektik involves exposing the patient to a small amount of radiation. A radiopharmaceutical examination is only performed when the nuclear medicine specialist determines that the benefits to the patient outweigh the risks associated with radiation exposure.

2. Important information before administration of Natrii fluoridum (18F) Synektik

Natrii fluoridum (18F) Synektik must not be administered

• if the patient is allergic (hypersensitive) to sodium fluoride (18F) or to any of the other components of this medicinal product (listed in section 6);
• if the patient is pregnant or suspects she might be pregnant, she should inform the nuclear medicine physician.

Warnings and precautions
Particular caution must be exercised when using Natrii fluoridum (18F) Synektik.
Before administration of Natrii fluoridum (18F) Synektik, the patient must inform the nuclear medicine physician performing the examination if:

• the patient is pregnant or suspects she might be pregnant;
• the patient is breastfeeding;
• the patient has impaired kidney function.

Before receiving Natrii fluoridum (18F) Synektik, the patient should

• drink plenty of water to ensure adequate hydration at the start of the examination and urinate as frequently as possible during the first few hours after completion of the scan.

Children and adolescents
If the patient is under 18 years of age, he or she should consult the nuclear medicine physician to whom they have been referred.

Natrii fluoridum (18F) Synektik and other medicines
The patient must inform the nuclear medicine physician performing the examination about all medications currently taken or recently taken, including those obtained without a prescription, as they may interfere with the interpretation of the resulting images.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning a pregnancy, she should consult her nuclear medicine physician before receiving this medicinal product.

Pregnancy
Natrii fluoridum (18F) Synektik must not be administered to pregnant patients.
Before administration of Natrii fluoridum (18F) Synektik, the patient must inform the nuclear medicine physician of any possible pregnancy or delayed menstruation.
In case of any doubts, the patient should consult the nuclear medicine physician supervising the examination.

Breastfeeding
If the patient is breastfeeding, breast milk may be expressed and stored prior to injection for later use. Breastfeeding must be discontinued for at least 12 hours after injection. Any breast milk expressed during this period must be discarded.
The patient should consult her nuclear medicine physician regarding when breastfeeding can be resumed.
It is recommended to avoid close contact with infants for the first 12 hours after injection.

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

Natrii fluoridum (18F) Synektik contains sodium
This medicinal product contains more than 1 mmol of sodium (up to 23 mg per dose); this should be taken into account in patients who require sodium-controlled diets.

3. How to use Natrii fluoridum (18F) Synektik

The use, handling, and disposal of radiopharmaceuticals are strictly regulated by relevant regulations. Natrii fluoridum (18F) Synektik is used exclusively in hospital settings. Only appropriately trained personnel qualified to handle radioactive substances safely will administer this product to patients. These individuals will take special care to ensure the product is used safely and will inform the patient about the procedures being performed.

The nuclear medicine physician supervising the examination will decide the amount of Natrii fluoridum (18F) Synektik to be administered to the patient. This will be the smallest quantity necessary to obtain the required diagnostic information.

The usual recommended dose in adults is 100 to 400 MBq. Megabecquerel (MBq) is a unit of radioactivity.

Use in children and adolescents
In children and adolescents, the administered amount will be adjusted according to body weight.

Administration of Natrii fluoridum (18F) Synektik and procedure details
Natrii fluoridum (18F) Synektik is administered as a single intravenous injection.

Duration of the examination
The supervising nuclear medicine physician will inform the patient how long the examination usually lasts. The PET scan is typically performed between 60 minutes and 3 hours after injection, depending on the type of procedure. After injection, the patient will be given water to drink and will be asked to empty the bladder immediately before the scan begins.

After receiving Natrii fluoridum (18F) Synektik, the patient should

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

The nuclear medicine physician will inform the patient if any special precautionary measures are necessary after receiving this medicinal product.
For any questions, please contact the supervising nuclear medicine physician.

Overdose of Natrii fluoridum (18F) Synektik
Overdose is highly unlikely, as the patient will receive only a single dose of Natrii fluoridum (18F) Synektik, carefully measured and verified by the supervising nuclear medicine physician. Nevertheless, if an overdose occurs, the patient will be given appropriate treatment. Elimination of the radioactive substance from the body should be maximized. The patient should drink as much fluid as possible and empty the bladder as frequently as possible. Diuretic medications may be required.

If you have any further questions about the use of Natrii fluoridum (18F) Synektik, please consult the nuclear medicine physician supervising the examination.

4. Possible adverse reactions

Like any medicinal product, Natrii fluoridum (18F) Synektik may cause adverse reactions, although they do not occur in everyone.
To date, no serious adverse reactions have been reported.
This radiopharmaceutical product will emit a small amount of ionizing radiation after administration, which is associated with a very low risk of developing malignant tumors and congenital abnormalities in offspring at a later stage.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the nuclear medicine physician who supervised the examination.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +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 helps to gather more information on the safety of this medicinal product.

5. How to store Natrii fluoridum (18F) Synektik

The patient will not have to store this product. Storage of this medicinal product in appropriate conditions is the responsibility of a specialist.
Radiopharmaceuticals are stored in accordance with national regulations concerning radioactive materials.
The following information is intended exclusively for specialists.
Natrii fluoridum (18F) Synektik must not be used after the expiry date stated on the label.

6. Contents of the pack and other information

What Natrii fluoridum (18F) Synektik contains

• The active substance is sodium fluoride (18F). One mL of solution contains sodium fluoride (18F) at an activity of 2.0 GBq at the time and date of calibration.
• The other components are water for injections and sodium chloride.

What Natrii fluoridum (18F) Synektik looks like and contents of the pack
A colourless solution in a 15 mL or 25 mL multidose vial.
The total activity per vial at the time and date of calibration ranges from 0.4 GBq to 44 GBq.

Marketing Authorisation Holder
SYNEKTIK S.A.
ul. Józefa Piusa Dziekońskiego 3
00-728 Warszawa
Poland

Manufacturer
Synektik Pharma Sp. z o.o.
ul. Artwińskiego 3
25-734 Kielce
Poland

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland Natrii fluoridum (18F) Synektik
Lithuania Natrii fluoridum (18F) Synektik 2.0 GBq/mL, injekcinis tirpalas
Slovak Republic METAFLU 2.0 GBq/mL, injekčný roztok

Other sources of information
Detailed information on this medicinal product 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 exclusively for healthcare professionals:
The full text of the Product Characteristics for Natrii fluoridum (18F) Synektik is provided as a separate document within the product packaging, to provide healthcare professionals with additional scientific and practical information regarding administration and use of this radiopharmaceutical.
Please refer to the Product Information Leaflet.