Cholscan 222 mbq/ml solucion inyectable

Patient Information Leaflet

CHOLSCAN 222 MBq/ml injectable solution

Fluorocoline chloride (18F)

Read this leaflet carefully before you receive this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your nuclear medicine physician who is supervising the procedure.
• If you experience any side effects, consult your nuclear medicine physician, even if they are not listed in this leaflet. See section 4.

1.What CHOLSCAN is and what it is used for

2.What you need to know before starting to use CHOLSCAN

3.How to use CHOLSCAN

4.Possible side effects

5.Storage of CHOLSCAN

6.Contents of the pack and additional information

This medication is a radiopharmaceutical for diagnostic use only.

CHOLSCAN is used by doctors for diagnostic purposes through a medical imaging procedure called positron emission tomography (PET) and is administered before the procedure.

Once a small amount of CHOLSCAN is injected, medical images obtained with a special camera will allow the doctor to obtain images and determine the location or progression of your disease.

The use of CHOLSCAN involves exposure to small amounts of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will obtain from the procedure is greater than the risk due to radiation.

The active ingredient contained in CHOLSCAN is fluorocolina chloride (18F) and is designed for the acquisition of diagnostic images of some parts of the body.

CHOLSCAN should not be used

• if you are allergic to fluorocolina chloride (18F) or any of the other components of this medication (listed in section 6)

Warnings and precautions

You should be especially careful with CHOLSCAN

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

Before administering CHOLSCAN, you must:

• drink a lot of water before the start of the examination to urinate as many times as possible during the first 4 hours after the procedure
• be fasting for at least 4 hours before administration
• avoid any strenuous physical activity

Children and adolescents

CHOLSCAN is not intended for use in children and adolescents under 18 years old.

Use of CHOLSCAN with other medications

Inform your nuclear doctor if you are taking, have taken recently, or may need to take any other medication, as these may interfere with image interpretation, particularly if you are being treated with anti-androgen therapy, antimitotic chemotherapy (colchicine or others), or any other treatment containing hematopoietic growth factors.

In case of doubt, ask your nuclear doctor for more information who will supervise the procedure.

Use of CHOLSCAN with food and beverages

You should remain fasting for at least 4 hours before administration, as some foods may decrease the quality of the images. You should drink a lot of water.

Pregnancy and breastfeeding

CHOLSCAN is not indicated for use in women.

Driving and operating machines

The effects on the ability to drive or operate machines have not been studied. However, it is considered unlikely that CHOLSCAN will affect your ability to drive or operate machines.

CHOLSCAN contains sodium

This product may contain more than 1 mmol of sodium (23 mg). You should take this into account if you are on a low-sodium diet.

There are strict guidelines for the use, handling, and disposal of radioactive substances.

CHOLSCANwill only be used in specially controlled areas. This product should only be handled and administered by trained and qualified personnel to ensure safe use. Those individuals will take special care in the safe use of this product and will inform you of their actions.

The nuclear physician overseeing the procedure will decide on the amount of CHOLSCAN to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The generally recommended dose ranges from 140 to 280MBq (depending on the patient's body mass, the type of camera used for image acquisition, and the image acquisition mode). The Megabecquerel (MBq) is the unit used to express radioactivity.

Administration of CHOLSCAN and procedure performance

CHOLSCAN is administered directly into a vein.

A single injection is sufficient to perform the procedure required by your physician.

After the injection, you will need to remain completely still, without reading or speaking. You will also be offered a drink and asked to urinate immediately before starting the procedure.

Procedure duration

Your nuclear physician will inform you of the typical duration of the procedure.

After CHOLSCAN administration, you must:

• avoid direct contact with small children and pregnant women for 12hours after the injection
• drink plenty of water and urinate frequently to eliminate the product from your body.

Your nuclear physician will inform you if any special precautions are necessary after receiving this medication. Consult with your nuclear physician if you have any doubts.

If you have been administered more CHOLSCAN than you should have

It is unlikely to experience an overdose, as you will receive a single, precisely controlled dose of CHOLSCAN administered by the nuclear physician overseeing the procedure. However, in the event of an overdose, you will receive the necessary treatment.

In particular, the nuclear physician in charge of the procedure may recommend that you drink plenty of water to facilitate the elimination of CHOLSCAN from your body (in fact, the primary route of elimination of this product is renal, through urine).

If you have any other questions about the use of CHOLSCAN, ask the nuclear physician overseeing the procedure.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary defects.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your nuclear medicine doctor. Even if it is adverse effects that do not appear in this prospectus. You can also report them directly through the national notification system included in theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This medication does not need to be stored by you. This medication will be stored under the responsibility of the specialist in suitable facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist.

Do not use this medication after the expiration date that appears on the label of the package after {DD MM AAAA hh:mm UTC}.

Composition of CHOLSCAN

• The active principle is fluorocholine chloride (18F): One milliliter of injectable solution contains 222 MBq of fluorocholine chloride (18F) at the time and date of calibration.
• The other excipients are sodium chloride 9 mg/ml and water for injectable preparations.

Appearance of the product and contents of the package

CHOLSCAN is a transparent and colorless solution.

The activity per vial oscillates between 111 MBq and 2220 MBq at the time and date of calibration.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Advanced Accelerator Applications Molecular Imaging France SAS

20 rue Diesel

01630 Saint-Genis-Pouilly

France

Responsible for manufacturing

Advanced Accelerator Applications Molecular Imaging France SAS

27 boulevard Jean Moulin

13005 Marseille

France

Advanced Accelerator ApplicationsMolecular 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 ApplicationsMolecular Imaging France SAS

126 Rocade Sud,

62660 Beuvry

France

Advanced Accelerator ApplicationsMolecular Imaging France SAS

3 rue Charles Lauer,

92210 Saint-Cloud,

France

Advanced Accelerator Applications Molecular Imaging Iberica S.L.U.

C/ Josep Anselm Clavé, 100

08950 Esplugues de Llobregat (Barcelona), Spain

Advanced Accelerator Applications Molecular Imaging Iberica S.L.U.

Hospital Clínico Universitario Virgen de la Arrixaca, Ctra. Madrid-Cartagena, s/n

30120 El Palmar (Murcia), Spain

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

Advanced Accelerator Applications Molecular Imaging Italy S.r.l.

Via Piero Maroncelli 40

47014 Meldola (FC)

Italy

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Advanced Accelerator Applications Molecular Imaging Iberica S.L.U.

C/ Josep Anselm Clavé 100,

08950 Esplugues de Llobregat, Barcelona

Spain

This medication is authorized in the Member States of the European Economic Area with the following names:

France, Germany: FLUOROCHOL

Italy, Spain: CHOLSCAN

Portugal: Cholview

This leaflet has been revised in: 10/2021

Other sources of information

The detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) ( https://www.aemps.gob.es).

This information is intended solely for medical professionals or healthcare professionals:

The complete technical file of CHOLSCAN is included as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the technical file (the technical file must be included in the box).