Cholscan

Package leaflet: Information for the user

CHOLSCAN 222 MBq/mL injection solution

Fluorocholine (¹⁸F) chloride
Please read this leaflet carefully before taking this medicine as it contains
important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult the nuclear medicine physician who will supervise the entire procedure.
• If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine physician. See section 4.

Contents of this leaflet

1. What CHOLSCAN is and what it is used for
2. What you need to know before taking CHOLSCAN
3. How to take CHOLSCAN
4. Possible side effects
5. How to store CHOLSCAN
6. Contents of the pack and other information

1. What CHOLSCAN is and what it is used for

This medicinal product is a radiopharmaceutical for diagnostic use only.
CHOLSCAN is used by physicians for diagnostic purposes during a medical imaging procedure called positron emission tomography (PET), and is administered before performing this examination.
After injecting a small amount of CHOLSCAN, images obtained using a special machine will enable the physician to visualize the location of the disease or monitor its progression.
The use of CHOLSCAN involves exposure to small doses of radioactivity. Your physician and the nuclear medicine specialist have determined that the clinical benefit you will derive from this procedure outweighs the risks associated with radiation exposure.
The active substance in CHOLSCAN is fluorocholine ( F) chloride, designed for diagnostic imaging of certain parts of the body.

2. What you need to know before taking CHOLSCAN

Do not take CHOLSCAN

• if you are allergic to flumeglumine (F) chloride or to any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions
Exercise particular caution with CHOLSCAN

• if you have kidney problems
• if you are on a low-sodium diet

Before taking CHOLSCAN you must:

• drink plenty of water before starting the examination, so as to urinate as frequently as possible during the first 4 hours after the study
• remain fasting for at least 4 hours before administration
• avoid any significant physical activity

Children and adolescents
CHOLSCAN is not intended for use in children and adolescents under 18 years of age.
Other medicines and CHOLSCAN
Inform the nuclear medicine specialist if you are taking, have recently taken, or might take any other medicines, as other medicines may interfere with the interpretation of images; particularly if undergoing anti-androgen therapy, anti-mitotic chemotherapy (colchicine or others), or any other treatment containing haematopoiesis-stimulating factors.
If you have any doubts, consult the nuclear medicine specialist who will supervise the procedure for further information.
CHOLSCAN with food and drinks
Before administration of the product, due to the possible degradation of images caused by certain foods, you must remain fasting for at least 4 hours. It is necessary to drink plenty of water.
Pregnancy and breastfeeding
CHOLSCAN is not indicated for use in women.
Driving and using machines
The effects on the ability to drive vehicles and use machinery have not been studied. However, it is considered unlikely that CHOLSCAN may affect your ability to drive vehicles or operate machinery.
CHOLSCAN contains sodium
This medicine may contain more than 1 mmol of sodium (23 mg). This should be taken into consideration if you are on a low-sodium diet.

3. How to take CHOLSCAN

There are very strict laws governing the use, handling, and disposal of radiopharmaceuticals.
CHOLSCAN must be used only in designated controlled areas. This product will be handled and administered exclusively by trained and qualified personnel capable of using it safely. Such personnel will pay particular attention to ensuring safe use of this medicinal product and will inform you about the procedures performed.

The nuclear medicine physician overseeing the procedure will determine the amount of CHOLSCAN to be used in your case. In any event, the smallest quantity necessary to obtain the required information will be administered.
The recommended activity ranges from 140 to 280 MBq (depending on the patient's body weight, the type of imaging equipment used, and the acquisition mode). The megabecquerel (MBq) is the unit of measurement for radioactivity.

Administration of CHOLSCAN and performance of the procedure
CHOLSCAN is injected directly into a vein.
A single injection is sufficient to carry out the examination required by the physician.
After the injection, you must remain completely at rest, without reading or talking. Furthermore, you will be offered something to drink and asked to urinate immediately before the procedure.

Duration of the procedure
The nuclear medicine physician will inform you about the expected duration of the procedure.

After receiving CHOLSCAN, you must:

• avoid any close contact with young children and pregnant women during the 12 hours following injection;
• drink plenty of water and urinate frequently to help eliminate the product from your body.

The nuclear medicine physician will inform you if specific precautions are required after receiving this medicinal product. If you have any questions, consult the nuclear medicine specialist.

If you have been given more CHOLSCAN than you should have received
Since you will receive only a single dose of CHOLSCAN under controlled conditions by the nuclear medicine specialist overseeing the procedure, the likelihood of an overdose is extremely low.
However, in the event of an overdose, appropriate treatment will be administered.
In particular, the nuclear medicine physician responsible for the procedure may advise you to drink abundant fluids to facilitate elimination of CHOLSCAN from the body (as the primary route of excretion for this product is renal, via urine).

If you have any doubts about the use of CHOLSCAN, consult the nuclear medicine physician overseeing the procedure.

4. Possible side effects

Like all medicines, this medicinal product may cause side effects, although not everyone experiences them.
This radiopharmaceutical will deliver low amounts of ionising radiation, associated with a minimal risk of cancer and hereditary abnormalities.
If you experience any side effect, including those not listed in this leaflet, consult your nuclear medicine physician.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your nuclear medicine physician. You may also report side effects directly via the website: www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. How to store CHOLSCAN

Do not store this medicinal product. The responsibility for storing this medicinal product lies with the specialist, in suitable premises. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended for the specialist only.
Do not use this medicinal product after the expiry date stated on the label following {DD MM YYYY hh:mm UTC}.

6. Package contents and other information

What CHOLSCAN contains

• The active substance is fluorocholine (F) chloride: One mL of injectable solution contains 222 MBq of fluorocholine (F) chloride at the date and time of calibration.
• The other components are sodium chloride 9 mg/mL and water for injectable preparations.

Description of the appearance of CHOLSCAN and contents of the pack
CHOLSCAN is a clear, colourless solution.
The radioactivity per vial ranges from 111 MBq to 2,220 MBq at the date and time of calibration.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Advanced Accelerator Applications Molecular Imaging France SAS
20 rue Diesel
01630 Saint Genis Pouilly
France

Manufacturers
Advanced Accelerator Applications Molecular Imaging France SAS
27 boulevard Jean Moulin
13005 Marseille
France
Advanced Accelerator Applications Molecular Imaging France SAS
20 rue Diesel
01630 Saint Genis Pouilly
France
Advanced Accelerator Applications (Portugal), Unipessoal, Lda
Rua Fonte das Sete Bicas, 170, Matosinhos
4460-203 Matosinhos
Portugal
Advanced Accelerator Applications Germany GmbH
Saime-Genc-Ring 18
53121 Bonn
Germany
Advanced Accelerator Applications Molecular Imaging France SAS
126 Rocade Sud
62660 Beuvry
France
Advanced Accelerator Applications Molecular Imaging France SAS
3 rue Charles Lauer
92210 Saint-Cloud
France
Advanced Accelerator Applications Ibérica SLU
Polígono Industrial La Cuesta-Sector-3. Parcelas 1-2, La Almunia de Doña Godina
50100 Zaragoza
Spain
Advanced Accelerator Applications Molecular Imaging Ibérica S.L.U.
C/ Josep Anselm Clavé, 100
08950 Esplugues de Llobregat (Barcelona)
Spain
Advanced Accelerator Applications Molecular Imaging Ibérica S.L.U.
Hospital Clínico Universitario Virgen de la Arrixaca
Ctra. Madrid-Cartagena, s/n
30120 El Palmar (Murcia)
Spain
Advanced Accelerator Applications (Italy) S.r.l.
Via Ribes 5
10010 Colleretto Giacosa (TO)
Italy
Advanced Accelerator Applications Molecular Imaging Italy S.r.l.
Via Dell’Industria
86077 Pozzilli (IS)
Italy
Advanced Accelerator Applications Molecular Imaging France SAS
Technopole de l’Aube
14 rue Gustave Eiffel
10430 Rosières Près Troyes
France
ITEL Telecomunicazioni S.r.l.
Via Antonio Labriola (Zona Industriale)
Snc - 70037 Ruvo Di Puglia (BA)
Italy

This medicinal product is authorised in the European Economic Area with the following names:
France, Austria, Germany, Luxembourg, Poland: FLUOROCHOL
Belgium, Italy, Lithuania, Spain, Netherlands: CHOLSCAN
Portugal: CHOLVIEW

Further information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency: http://www.agenziafarmaco.gov.it.

The following information is intended exclusively for healthcare professionals:
The full Product Characteristic Summary of CHOLSCAN is included as a separate document in the medicinal product’s packaging, with the aim of providing healthcare professionals with additional scientific and practical information for the administration and use of this radiopharmaceutical.
Please refer to the Summary of Product Characteristics (the Summary of Product Characteristics must be included in the package).