Fch

Poland
Brand name Fch
Form solution for injection
Active substance / Dosage
fluorocholine · 1 GBq/ml
Prescription type Prescription only – restricted use
ATC code
V09IX07
Registration number 100414158
Manufacturer Centrum Produkcji Radiofarmaceutyków Voxel S.A.

Table of Contents

Package leaflet: Information for the patient

FCH, 1 GBq/ml on reference date and time, solution for injection
Fluorocholine ( F)
Please read the entire leaflet before use, as it contains
important information for the patient.

  • Keep this leaflet for future reference.
  • If you have any further questions, consult the physician referring you or the specialist supervising the examination in the field of nuclear medicine.
  • If any adverse reactions occur, including any possible adverse reactions not listed in this leaflet, inform the physician who referred you for the examination or the nuclear medicine specialist supervising the examination.

Table of contents of the leaflet:

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

1. WHAT FCH IS AND WHAT IT IS USED FOR

This medicinal product is a radiopharmaceutical intended solely for diagnostic purposes.
FCH is used for diagnostic imaging with positron emission tomography (PET/CT or PET/MR) and is administered prior to the scan.
The active substance in FCH enables imaging of increased uptake of the natural substance choline in abnormal organs or tissues during PET/CT or PET/MR scans.
This examination will help in making decisions regarding the management of a diagnosed or suspected disease.

2. IMPORTANT INFORMATION BEFORE USING THE MEDICINAL PRODUCT FCH

When not to use FCH

  • if the patient is allergic (hypersensitive) to the active substance, fluorocholine (F), or to any of the other components of FCH;
  • if the patient is pregnant.

When to exercise special caution when using FCH

  • if the patient's kidneys are not functioning properly. In such a case, careful consideration of the indication for performing the examination is required, as the patient may be exposed to increased radiation;
  • in case of contact with young children: close contact between the patient and young children should be avoided during the first 12 hours after injection. The nuclear medicine specialist should be informed in the following cases:
  • if the patient is pregnant or suspects she may be pregnant;
  • if the patient is breastfeeding;
  • if the patient is under 18 years of age.

Before administration of FCH, the patient should:

  • drink plenty of water to ensure adequate hydration prior to the start of the examination, in order to urinate as frequently as possible during the first hours after the examination;
  • refrain from eating for at least 4 hours.

FCH and other medicinal products
Inform your treating physician or the nuclear medicine specialist supervising the examination about all medicinal products currently or recently taken, including those available without a prescription, as they may negatively affect the physician's interpretation of the images; particularly if currently or previously undergoing treatment with antiandrogenic medicinal products.
In case of doubt, consult the physician or nuclear medicine specialist performing the PET examination for further information.
Administration of FCH with food and drink
Do not eat for at least 4 hours before receiving FCH.
Pregnancy and breastfeeding
Before administration of FCH, inform the nuclear medicine specialist if there is any possibility that the patient may be pregnant, if menstruation has not occurred, or if the patient is breastfeeding.
In case of doubt, it is important to consult the treating physician or the nuclear medicine specialist supervising the examination.
If the patient is pregnant
FCH should not be administered if the patient is pregnant.
The treating physician will consider performing this examination during pregnancy only if absolutely necessary.
If the patient is breastfeeding
If administration of FCH is necessary during breastfeeding, breast milk should be expressed and stored for later use prior to injection. Breastfeeding must be interrupted for at least 8 hours. Breast milk expressed during this period must be discarded.
Driving and operating machinery
It is unlikely that FCH will affect the ability to drive or operate machinery.

3. HOW TO USE THE MEDICINAL PRODUCT FCH

There are strict regulations governing the use, handling, and disposal of radiopharmaceuticals. The medicinal product FCH will only be administered in authorized medical facilities. The preparation and administration of the product may be carried out exclusively by personnel with appropriate training and qualifications regarding the safe use of this medicinal product. These personnel ensure that the product is used safely and will inform the patient how the medicinal product is administered.

The nuclear medicine specialist supervising the procedure will determine the amount of FCH to be administered in the individual case. This will be the smallest quantity necessary to obtain the required diagnostic information.

The recommended administered activity for an adult usually ranges from 200 to 500 MBq.
The megabecquerel (MBq) is a metric unit of measurement of radioactivity.

Administration of FCH and performance of the scan

FCH is administered as a single intravenous injection.

Duration of the procedure

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

After administration of FCH, the patient should:

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

Administration of a higher than recommended dose of FCH

Overdose is highly unlikely, as the patient will receive a single dose of FCH under strict supervision of the responsible nuclear medicine specialist. However, in the event of an overdose, appropriate treatment will be provided.

If you have any further questions regarding the use of FCH, please consult the referring physician or the nuclear medicine specialist supervising the procedure.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, medicine FCH can cause adverse reactions, although not everyone experiences them.
To date, no adverse reactions have been observed.
Administration of FCH delivers a small dose of ionizing radiation with a very low level of risk of radiation-related adverse effects.
The attending physician has determined that the clinical benefit of the examination using the radiopharmaceutical product outweighs the radiation risk.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor or pharmacist. 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
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 provide more information on the safety of the medicine.

5. HOW TO STORE MEDICINAL PRODUCT FCH

No special storage requirements apply. Do not freeze.
The patient will not store this medicinal product. This medicinal product is stored under the supervision of a nuclear medicine specialist in appropriate facilities.
Keep the medicinal product out of the sight and reach of children.
Radiopharmaceuticals must be stored in accordance with current regulations concerning radioactive materials.
Do not use the medicinal product after the expiry date stated on the label (EXP), including the specific day and time.

6. OTHER INFORMATION

What FCH contains

  • The active substance is fluorocholine (F). 1 ml of injection solution contains 1 GBq of fluorocholine (F) at the reference date and time.
  • Other components: water for injections.

What FCH looks like and contents of the pack
The patient does not need to purchase the product independently, nor is it necessary
to handle the packaging or the vial. The following information is provided for
informational purposes only.
FCH is a clear, colourless solution.
Packaging: a 15 ml colourless type I glass vial, closed with a chlorobutyl rubber stopper and aluminium seal, placed in a tungsten or lead shielding container.
Activity per vial ranges from 0.5 GBq to 10 GBq at the reference date and time.

Marketing Authorisation Holder and Manufacturer
VOXEL S.A.
ul. Wielicka 265
30-663 Kraków
Poland

Information intended only for medical professionals:
The full Product Characteristics document for FCH, 1 GBq/ml, solution for injection is available as a separate document intended to provide healthcare professionals with additional scientific evidence and practical information regarding the administration and use of this radiopharmaceutical product.
Please consult the Product Characteristics Leaflet (SmPC, included in the package).