Fluorocholine (18f) synektik

Package leaflet: Information for the patient

FLUOROCHOLINE ( F) SYNEKTIK 1 GBq/mL, solution for injection
fluorocholine ( F) chloride
Please read this leaflet carefully before the administration of this medicinal product because it contains important information for you.

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

Leaflet contents:

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

1. What Fluorocholine (F) S is and what it is used for

This medicinal product is a radiopharmaceutical intended solely for diagnostic use, administered prior to positron emission tomography (PET) imaging.
Well-documented indications for PET imaging with fluorocholine (F) chloride include prostate cancer and hepatocellular carcinoma.
The active substance in Fluorocholine (F) S enables imaging of increased uptake of the natural substance choline by specific organs or tissues, which is then detected during PET scanning and visualized as an image.
Positron emission tomography is an imaging technique used in nuclear medicine to generate cross-sectional images of living organisms. A very small amount of radiopharmaceutical is used to obtain quantitative and precise images of specific metabolic processes in the body. This examination is intended to assist in making decisions regarding the management of a diagnosed or suspected disease.
Administration of Fluorocholine (F) Synektik involves exposure to a small amount of radioactive radiation.
Your physician has determined that the clinical benefit derived from this radiopharmaceutical examination outweighs the radiation-related risk.

2. Important information before using the medicine F (F) S

When not to use F (F) S

• if the patient is allergic to fluorocholine chloride (F), or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is pregnant.

Warnings and precautions
The following situations require informing the nuclear medicine specialist before
administration of F (F) S:

• if the patient is pregnant or suspects she might be pregnant;
• if the patient is breastfeeding;
• if the patient's kidneys are not functioning properly; in such cases, careful consideration of the indication for the examination is required, as the patient may be exposed to increased radiation;
• in case of contact with young children: it is recommended to avoid close contact between the patient and young children during the first 12 hours after injection.

Before administration of F (F) S, the patient should:

• drink plenty of water before starting the examination, to ensure frequent urination during the first hours after completion;
• refrain from eating for at least 4 hours.

Children and adolescents
Inform the nuclear medicine specialist if the patient is under 18 years of age.
F (F) S and other medicines
Other medicines may affect the interpretation of examination results. Therefore, inform the nuclear medicine specialist about all medicines currently or previously used by the patient, as well as any planned treatments. This particularly includes current or prior treatment with androgen receptor antagonists, antimitotic chemotherapeutic agents (colchicine or others), or hematopoietic colony-stimulating factors (colony-stimulating factor – CSF).
If in doubt, consult the nuclear medicine specialist performing the PET scan, who will provide further information.
Use of F (F) S with food and drink
For at least 4 hours before receiving F (F) S, no food should be consumed. However, it is important to drink large amounts of water both before and after the examination.
Pregnancy and breastfeeding
Before administration of F (F) S, inform the nuclear medicine specialist if there is any possibility that the patient is pregnant, if menstruation has not occurred, or if the patient is breastfeeding.
If in doubt, it is important to consult the nuclear medicine specialist supervising the examination.
If the patient is pregnant
This medicine must not be administered to pregnant women.
If the patient is breastfeeding
If administration of the medicine during breastfeeding is necessary, milk should be expressed and stored for later use prior to injection. Breastfeeding should be interrupted for at least 12 hours. Breast milk collected during this period must be discarded.
Ask the nuclear medicine specialist when it is safe to resume breastfeeding.
Driving and operating machinery
No studies have been conducted on the effects of this medicine on the ability to drive or operate machinery.
F (F) S contains sodium
Depending on the preparation time of the injection for the patient, the sodium content may in some cases exceed 1 mmol (23 mg). This should be taken into account in patients on a low-sodium diet.

3. How to use Fluorocholine (18F) Synektik

The use, handling, and disposal of radiopharmaceuticals are subject to strict regulations. Fluorocholine (18F) Synektik will be administered in specially prepared facilities. The product will be prepared and administered exclusively by trained and qualified medical personnel, in accordance with safety principles and stringent regulations governing the preparation, use, and disposal of radiopharmaceuticals. Staff will strictly adhere to safety procedures when using the product and will inform the patient about the procedures being performed.

The nuclear medicine specialist supervising the examination will decide on the amount of Fluorocholine (18F) Synektik to be administered to the patient. This will be the smallest amount necessary to obtain the required diagnostic information.

The recommended administered activity for an adult usually ranges from 140 to 280 MBq, depending on the patient's body weight, type of camera, and imaging method.

Megabecquerel (MBq) is the unit used to express radioactivity.

Use in children and adolescents
The use of this medicinal product is not recommended in children and adolescents with tumour disease.

Administration of Fluorocholine (18F) Synektik and the procedure
Fluorocholine (18F) Synektik is administered by intravenous injection.
A single injection is sufficient for the entire examination.

After injection, the patient will be given a drink and advised to empty the bladder shortly before the start of the examination.

Duration of the examination
The nuclear medicine specialist will inform the patient about the usual duration of the examination.

After administration of Fluorocholine (18F) Synektik, the patient should:

• avoid close contact with small children for 12 hours after injection;
• urinate frequently to accelerate the elimination of the product from the body.

The nuclear medicine specialist will inform the patient if any special precautions need to be taken after receiving the product. If in doubt, consult the supervising nuclear medicine specialist.

Administration of a higher than recommended dose of Fluorocholine (18F) Synektik
Overdose is unlikely, as the patient will receive a single dose of Fluorocholine (18F) Synektik under the strict supervision of the nuclear medicine specialist overseeing the examination. However, in the event of an overdose, appropriate treatment will be administered. The supervising nuclear medicine specialist may advise the patient to drink large amounts of fluid to facilitate the elimination of Fluorocholine (18F) Synektik from the body (as this medicinal product is primarily eliminated via the kidneys in urine). Diuretic medications may be required.

If there are any further doubts regarding the use of Fluorocholine (18F) Synektik, please consult the nuclear medicine specialist supervising the examination.

4. Possible adverse reactions

Like all medicinal products, this medicine can cause adverse reactions, although not everyone experiences them.
No adverse reactions have been observed to date.
This radiopharmaceutical product emits a small amount of ionizing radiation, which is associated with cancer and genetic disorders; however, the risk of developing these is very low.
The treating physician has determined that the clinical benefit derived from the examination using this radiopharmaceutical product outweighs the radiation-related risk.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the nuclear medicine physician.
Adverse reactions can be reported directly to the Department of Monitoring of 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 responsible entity.
Reporting adverse reactions enables the collection of additional information on the safety of the medicine.

5. How to store Fluorocholine (18F) Synektik

The product will not be stored by patients, but by qualified personnel in a special room.
Radiopharmaceutical products are stored in accordance with national regulations concerning radioactive materials.
The following information is intended exclusively for specialized medical personnel.
Do not use the product after the expiry date stated on the label after "EXP".

6. Contents of the pack and other information

What Fluorocholine (18F) Synektik contains

• The active substance is fluoromethyl-(18F)-dimethyl-2-hydroxyethyl-ammonium chloride [fluorocholine (18F) chloride].
• 1 mL of injection solution contains 1 GBq = 1,000 MBq of fluorocholine (18F) chloride at the time and date of calibration.
• The other ingredients are: sodium chloride and water for injections.

What Fluorocholine (18F) Synektik looks like and contents of the pack
The patient does not need to purchase the medicine independently, nor is it necessary to handle the packaging or vial. The following information is provided for informational purposes only.
Fluorocholine (18F) Synektik is a clear, colourless solution.
Activity per vial ranges from 500 MBq to 15,000 MBq at the time and date of calibration.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
SYNEKTIK S.A.
ul. Józefa Piusa Dziekońskiego 3
00-728 Warsaw
e-mail: [email protected]

Manufacturer
Synektik Pharma Sp. z o.o.
ul. Szaserów 128
04-349 Warsaw
Poland
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:
Lithuania FLUOROCHOLINE (18F) SYNEKTIK 1 GBq/ml injekcinis tirpalas
Poland FLUOROCHOLINE (18F) SYNEKTIK
Czech Republic Fluorocholine (18F) Synektik
Slovakia FLUOROCHOLINE (18F) SYNEKTIK 1 GBq/mL, injekčný roztok

Detailed information about this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: https://www.urpl.gov.pl

Information intended exclusively for medical or healthcare personnel:
the complete Product Information (SmPC) for Fluorocholine (18F) Synektik is supplied as a separate document within the product packaging, to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical product.
Please consult the SmPC (the SmPC should be included in the packaging).