Fluoroholine (18f) Sinektik

PATIENT INFORMATION LEAFLET

Enclosed leaflet: Information for the patient

FLUOROCHOLINE (18F) SYNEKTIK 1 GBq/mL, solution for injection

Fluorocholine (18F) chloride

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a specialist doctor in nuclear medicine who is supervising the examination.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform the specialist doctor in nuclear medicine who is supervising the examination. See section 4.

Table of contents of the leaflet:

• 1. What is F (18F) S and what is it used for
• 2. Important information before using F (18F) S
• 3. How to use F (18F) S
• 4. Possible side effects.
• 5. How to store F (18F) S
• 6. Contents of the pack and other information.

1. What is F (18F) S and what is it used for

This medicine is a radiopharmaceutical product intended solely for diagnostic purposes, used in positron emission tomography (PET) examinations and administered before such an examination.
Well-documented indications for PET examinations with fluorocholine (18F) chloride include prostate cancer and hepatocellular carcinoma.
The active substance of F (18F) S enables imaging of the increased uptake of the natural substance, choline, by specific organs or tissues, which is then detected in the PET examination and displayed as an image.
Positron emission tomography is an imaging technique used in nuclear medicine, which produces cross-sectional images of living organisms. A very small amount of the radiopharmaceutical product is used to obtain quantitative and precise images of specific metabolic processes in the body. The purpose of this examination is to facilitate decisions regarding the treatment of a diagnosed or suspected disease.
The use of Fluorocholine (18F) Synektik is associated with exposure to a small amount of radioactive radiation.
The treating physician has determined that the clinical benefit of the examination using the radiopharmaceutical product outweighs the risk associated with radiation.

2. Important information before using F (18F) S

When not to use F (18F) S

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

Warnings and precautions

In the following cases, the patient should inform the specialist in nuclear medicine before using F (18F) S:

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

Before administering F (18F) S:

• the patient should drink a large amount of water before the examination to urinate as frequently as possible in the first few hours after the examination;
• the patient should not eat for at least 4 hours.

Children and adolescents

The patient should inform the specialist doctor in nuclear medicine if the patient is under 18 years of age.

F (18F) S and other medicines

Other medicines may affect the evaluation of the examination results. Therefore, the patient should inform the specialist doctor in nuclear medicine about all medicines currently or previously used by the patient, as well as planned treatment. This is particularly important for current or previous treatment with androgen receptor antagonists, antimicrotubule chemotherapeutics (colchicine or others), or hematopoietic growth factor therapy (colony-stimulating factor, CSF).
In case of doubts, the patient should consult the specialist doctor in nuclear medicine who is performing the PET examination, who will provide further information.

Using F (18F) S with food and drink

For at least 4 hours before receiving F (18F) S, the patient should not consume any food, but should drink large amounts of water before and after the examination.

Pregnancy and breastfeeding

Before administering F (18F) S, the patient should inform the specialist doctor in nuclear medicine if there is a possibility that the patient is pregnant, has not had a menstrual period, or is breastfeeding.
In case of doubts, it is essential to consult the specialist doctor in nuclear medicine who will supervise the examination.
If the patient is pregnant
The medicine should not be administered to pregnant women.
If the patient is breastfeeding
If it is necessary to administer the medicine during breastfeeding, the patient should express milk and store it for later use before injection. The patient should stop breastfeeding for at least 12 hours. The milk obtained during this time should be discarded.
The patient should ask the specialist doctor in nuclear medicine when they can resume breastfeeding.

Driving and using machines

No studies have been conducted on the effect of the medicine on the ability to drive and use machines.

F (18F) S contains sodium

Depending on the preparation time of the injection for the patient, the sodium content may be higher than 1 mmol (23 mg) in some cases. This should be taken into account for patients on a low-sodium diet.

3. How to use F (18F) S

The use, handling, and disposal of radiopharmaceutical products are subject to strict regulations. F (18F) S will be used in specially prepared rooms. The product will be prepared and administered only by trained and qualified medical personnel, in accordance with safety rules and strict regulations governing the preparation, use, and disposal of radiopharmaceutical products. The personnel will strictly follow the rules for safe use of the product and inform the patient about the procedures being performed.
The specialist doctor in nuclear medicine supervising the examination will decide on the amount of F (18F) S to be administered to the patient. This will be the smallest amount necessary to obtain the required information.
The recommended dose for an adult is usually an activity of 140 to 280 MBq, depending on the patient's weight and the type of camera and image acquisition method.
Megabecquerel (MBq) is the unit used to express radioactivity.

Use in children and adolescents

The use of this medicine is not recommended in children and adolescents with cancer.

Administration of F (18F) S and performance of the examination

F (18F) S is administered by intravenous injection.
A single injection is sufficient for the entire examination.
After injection of the product, the patient will receive a liquid to drink and will be advised to urinate just before the start of the examination.

Duration of the examination

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

After administration of F (18F) S:

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

The specialist doctor in nuclear medicine will tell the patient if any special precautions are necessary after receiving the product. In case of questions, the patient should consult the specialist doctor in nuclear medicine.

Overdose of F (18F) S

Overdose is unlikely, as the patient will receive a single dose of F (18F) S under the strict control of the specialist doctor in nuclear medicine supervising the examination. However, in case of overdose, the patient will receive appropriate treatment. The specialist doctor in nuclear medicine supervising the examination may advise the patient to drink large amounts of fluid to facilitate the elimination of F (18F) S from the body (since this medicine is mainly eliminated through the kidneys, in the urine). The use of diuretics may be necessary.
In case of any further doubts regarding the use of F (18F) S, the patient should consult the specialist doctor in nuclear medicine who is supervising the examination.

4. Possible side effects

Like all medicines, F (18F) S can cause side effects, although not everybody gets them.
No side effects have been observed so far.
This radiopharmaceutical product emits a small amount of ionizing radiation, which is associated with cancer and genetic disorders, but the risk of their occurrence is very low.
The treating physician has determined that the clinical benefit of the examination using the radiopharmaceutical product outweighs the risk associated with radiation.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, the patient should inform the doctor in nuclear medicine.
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:
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
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for the collection of more information on the safety of the medicine.

5. How to store F (18F) S

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 regarding radioactive materials.
The following information is intended only for specialized medical personnel.
The product should not be used after the expiry date stated on the label after "EXP".

6. Contents of the pack and other information

What F (18F) S contains

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

What F (18F) S looks like and contents of the pack

The patient does not need to purchase the medicine themselves, nor is it necessary to handle the packaging or vial. The following information is provided for informational purposes only.
F (18F) S is a clear and colorless solution.
The activity per vial is between 500 MBq and 15,000 MBq on the date and time of calibration.

Marketing authorization holder and manufacturer

Marketing authorization 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 authorized in the Member States of the European Economic Area 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

Date of last revision of the leaflet: 02.12.2024

Detailed information about this medicine 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 only for healthcare professionals or healthcare workers:
a complete Summary of Product Characteristics (SmPC) of F (18F) S is provided as a separate document in the product packaging, to provide healthcare workers with additional scientific and practical information on the administration and use of this radiopharmaceutical product.
The SmPC should be consulted (the SmPC should be attached to the packaging).