CHOLSCAN 222 MBq/mL INJECTABLE SOLUTION

Introduction

Patient Information Leaflet

CHOLSCAN 222 MBq/ml injectable solution

Fluorocoline chloride (18F)

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

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

Contents of the pack

1. What CHOLSCAN is and what it is used for
2. What you need to know before you are given CHOLSCAN
3. How CHOLSCAN is used
4. Possible side effects
5. Storage of CHOLSCAN
6. Package contents and further information

1. What CHOLSCAN is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

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

Once a small amount of CHOLSCAN is injected, the 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 nuclear medicine doctor have considered that the clinical benefit you will obtain from the procedure outweighs the risk due to radiation.

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

2. What you need to know before you are given CHOLSCAN

CHOLSCAN must not be used

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

Warnings and precautions

Be careful with CHOLSCAN

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

Before administration of CHOLSCAN, you must:

• drink plenty of water before the start of the examination to urinate as many times as possible during the first 4 hours after the procedure
• fast 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 of age.

Use of CHOLSCAN with other medicines

Tell your nuclear medicine doctor if you are taking, have recently taken, or might take any other medicines, as these may interfere with the interpretation of the images, particularly if you are being treated with anti-androgen therapy, antimitotic chemotherapy (colchicine or others) or any other treatment containing hematopoietic stimulants.

In case of doubt, ask your nuclear medicine doctor for more information.

Use of CHOLSCAN with food and drinks

Before administration of the product, you must fast for at least 4 hours, as some foods may decrease the quality of the images. You should 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 or use machines have not been studied. However, it is considered unlikely that CHOLSCAN will affect your ability to drive or use 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.

3. How CHOLSCAN is used

There are strict rules for the use, handling, and disposal of radiopharmaceuticals.

CHOLSCAN will only be used in special controlled areas. This product should only be handled and administered by trained and qualified personnel to use it safely. These people will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine doctor supervising the procedure will decide the amount of CHOLSCAN to be used in your case. This will be the smallest amount necessary to obtain the desired information.

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

Administration of CHOLSCAN and performance of the procedure

CHOLSCAN is administered directly into a vein.

A single injection is sufficient to perform the procedure that your doctor needs.

After the injection, you will have to remain completely at rest, without reading or talking. You will also be offered a drink and asked to urinate immediately before starting the procedure.

Duration of the procedure

Your nuclear medicine doctor will inform you of the usual duration of the procedure.

After administration of CHOLSCAN, you must:

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

Your nuclear medicine doctor will inform you if you need to take any special precautions after receiving this medicine. Consult your nuclear medicine doctor if you have any doubts.

If you have been given more CHOLSCAN than you should

Overdose is unlikely because you will receive a single, precisely controlled dose of CHOLSCAN by the nuclear medicine doctor supervising the procedure. However, in case of overdose, you will receive the appropriate treatment.

In particular, the nuclear medicine doctor 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 main route of elimination of this product is renal, in the urine).

If you have any further questions about the use of CHOLSCAN, ask your nuclear medicine doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and genetic disorders.

Reporting of side effects

If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. You can also report them directly through the national reporting system included in the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of CHOLSCAN

You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended only for specialists.

Do not use this medicine after the expiry date stated on the label of the package after {DD MM AAAA hh:mm UTC}.

6. Package contents and further information

Composition of CHOLSCAN

• The active ingredient is fluorocoline chloride (18F): 1 ml of injectable solution contains 222 MBq of fluorocoline chloride (18F) at the date and time of calibration.
• The other excipients are sodium chloride 9 mg/ml and water for injectable preparations.

Appearance of the product and package contents

CHOLSCAN is a clear and colorless solution.

The activity per vial ranges from 111 MBq to 2220 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

Manufacturer

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 obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

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

C/ Josep Anselm Clavé 100,

08950 Esplugues de Llobregat, Barcelona

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

France, Germany: FLUOROCHOL

Italy, Spain: CHOLSCAN

Portugal: Cholview

This leaflet was last revised in: 10/2021

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (https://www.aemps.gob.es).

This information is intended only for healthcare professionals:

The full summary of product characteristics of CHOLSCAN is included as a separate document in the package of the product, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the summary of product characteristics (the summary of product characteristics must be included in the box).