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Package Leaflet: Information for the Patient

FCH, 1 GBq/ml on the reference date, solution for injection

Fluorocholine (F)

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

• Keep this leaflet, you may need to read it again.
• In case of any further questions, consult the doctor who prescribed the examination or the specialist doctor in the field of nuclear medicine who supervised the examination.
• If any side effects occur, including any possible side effects not listed in this leaflet, tell the doctor who prescribed the examination or the specialist doctor in the field of nuclear medicine who supervised the examination.

Table of Contents of the Leaflet:

• 1. What is FCH and what is it used for
• 2. Important information before using FCH
• 3. How to use FCH
• 4. Possible side effects
• 5. How to store FCH
• 6. Other information

1. WHAT IS FCH AND WHAT IS IT USED FOR

This medicinal product is a radiopharmaceutical intended solely for diagnostic purposes.
FCH is used for diagnostic purposes in examinations using positron emission tomography (PET/CT or PET/MR) and is administered before the examination.
The active substance of FCH enables imaging of increased uptake of natural choline substance by changed organs or tissues in the PET/CT or PET/MR examination.
The examination will help in making decisions about the treatment of the diagnosed or suspected disease.

2. IMPORTANT INFORMATION BEFORE USING FCH

When not to use FCH

When to exercise special caution when using FCH

Before administering FCH:

• drink plenty of water to be well hydrated before the examination starts, in order to urinate as frequently as possible during the first hours after the examination;
• do not eat for at least 4 hours.

FCH and other medicines

Tell the doctor who prescribed the examination or the specialist doctor in nuclear medicine who will supervise the examination about all medicines that are currently being taken or have been taken recently, including those that are available without a prescription, as they may have a negative impact on the interpretation of images by the doctor; in particular, in the case of current or past treatment with anti-androgenic medicines.
In case of doubts, consult the doctor or specialist doctor in nuclear medicine who will perform the PET examination to obtain further information.

Using FCH with food and drink

Do not eat for at least 4 hours before receiving FCH.

Pregnancy and breastfeeding

Before administering FCH, inform the specialist doctor in nuclear medicine if there is a possibility that the patient is pregnant, has not had a menstrual period, or if the patient is breastfeeding.
In case of doubts, it is important to ask the doctor who prescribed the examination or the specialist doctor in nuclear medicine who will supervise the examination.

If the patient is pregnant

Do not administer FCH if the patient is pregnant.
The doctor will consider performing this examination during pregnancy only in case of absolute necessity.

If the patient is breastfeeding

If it is necessary to administer the medicine during breastfeeding, express milk before injection and store it for later use. Stop breastfeeding for at least 8 hours. Destroy the breast milk obtained during this time.

Driving and using machines

It is unlikely that FCH will affect the ability to drive and use machines.

3. HOW TO USE FCH

There are strict regulations regarding the use of radiopharmaceuticals, their handling, and disposal. FCH will only be used in authorized medical facilities. The medicine can only be prepared and administered by persons with appropriate training and qualifications in the safe use of this medicine. These persons will ensure that the medicine is used safely and will inform the patient how the medicine is administered.
The specialist doctor in nuclear medicine who supervises the examination will decide on the amount of FCH to be used in an individual case. This will be the smallest amount necessary to obtain the desired information.
The amount to be administered, usually recommended for an adult, is from 200 to 500 MBq.
Megabecquerel (MBq) is a metric unit of measurement of radioactivity.

Administering FCH and performing the examination

FCH is administered in a single intravenous injection.

Duration of the examination

The doctor will inform the patient about the usual duration of the examination.

After administering FCH:

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

Using a higher dose of FCH than recommended

Overdose is almost impossible, as the patient receives a single dose of FCH under the strict control of the specialist doctor supervising the examination. However, in case of overdose, the patient will receive appropriate treatment.
In case of any further doubts regarding the use of FCH, consult the doctor who prescribed the examination or the specialist doctor in nuclear medicine who supervises the examination.

4. POSSIBLE SIDE EFFECTS

Like all medicines, FCH can cause side effects, although not everybody gets them. So far, no side effects have been observed.
The administration of FCH provides a small dose of ionizing radiation with a very low degree of risk of adverse effects related to radiation.
The doctor has decided 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 possible side effects not listed in this leaflet, tell the doctor or pharmacist. 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
02-222 Warsaw
tel: + 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 more information to be collected on the safety of the medicine.

5. HOW TO STORE FCH

There are no special precautions for storing the medicine. Do not freeze.
The patient will not store this medicine. This medicine is stored under the supervision of a nuclear medicine specialist in appropriate premises.
The medicine should be stored out of sight and reach of children.
Radiopharmaceuticals should be stored in accordance with the applicable regulations regarding radioactive materials.
Do not use the medicine after the expiry date, i.e., the date and time stated on the label after EXP.

6. OTHER INFORMATION

What FCH contains

• The active substance is fluorocholine (F). 1 ml of the solution for injection contains 1 GBq of fluorocholine (F) on the reference date.
• It also contains: water for injections.

What FCH looks like and what the pack contains

The patient does not need to purchase the preparation themselves, nor is it necessary to deal with the packaging or vial. The following information is provided solely for informational purposes.

FCH is a clear and colorless solution.
Packaging: a 15 ml glass vial of type I, closed with a chlorobutyl rubber stopper and an aluminum seal, placed in a tungsten or lead shielding container.
The activity per vial is from 0.5 GBq to 10 GBq on the reference date.

Marketing authorization holder and manufacturer

VOXEL S.A.

ul. Wielicka 265
30-663 Krakow
Poland

Date of last revision of the leaflet:

Information intended for healthcare professionals only:

The full Summary of Product Characteristics of FCH, 1 GBq/ml, solution for injectionis available as a separate document, which aims to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical product.
Read the Summary of Product Characteristics (SPC, found in the package)