Cholscan 222 MBq/ml solution for injection
SpainTable of Contents
Package leaflet: Information for the patient
Introduction
Package leaflet: information for the patient
CHOLSCAN 222 MBq/ml solution for injection
Fluorocholine chloride (18F)
Read the entire leaflet carefully before you are administered this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult the nuclear medicine physician supervising the procedure.
- If you experience any adverse reactions, consult your nuclear medicine physician, even if they are adverse reactions not listed in this leaflet. See section 4.
Contents of the leaflet
- What CHOLSCAN is and what it is used for
- What you need to know before being administered CHOLSCAN
- How CHOLSCAN is administered
- Possible side effects
- How CHOLSCAN is stored
- Contents of the pack and other information
1. What CHOLSCAN is and what it is used for
This medicine is a radiopharmaceutical for diagnostic use only.
CHOLSCAN is used by physicians for diagnostic purposes in a medical imaging procedure called positron emission tomography (PET), and is administered prior to this study.
After a small amount of CHOLSCAN is injected, medical images obtained using a special camera will allow the physician to visualize and determine the location or progression of your disease.
The use of CHOLSCAN involves exposure to small amounts of radioactivity. Your physician and the nuclear medicine physician have determined that the clinical benefit you will derive from the procedure outweighs the risk associated with radiation exposure.
The active substance in CHOLSCAN is fluorocholine chloride (18F), which is intended for diagnostic imaging of certain parts of the body.
2. What you need to know before using CHOLSCAN
CHOLSCAN must not be used
- if you are allergic to fluorocholine chloride (18F) or to any of the other components of this medicine (listed in section 6)
Warnings and precautions
Take special care 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 and urinate as frequently as possible during the first 4 hours after the procedure
- fast for at least 4 hours prior to administration
- avoid any significant 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
Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines, as they may interfere with image interpretation, particularly if you are receiving antiandrogen therapy, antimitotic chemotherapy (colchicine or others), or any treatment containing hematopoietic growth factors.
If in doubt, ask your nuclear medicine physician for further information. The procedure will be supervised by your nuclear medicine physician.
Use of CHOLSCAN with food and drink
You must fast for at least 4 hours before administration of the product, as certain foods may reduce image quality. You should drink plenty of water.
Pregnancy and breastfeeding
CHOLSCAN is not indicated for use in women.
Driving and use of machines
The effects on the ability to drive or operate machinery have not been studied. However, CHOLSCAN is considered unlikely to affect your ability to drive or operate machinery.
CHOLSCAN contains sodium
This product 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 use CHOLSCAN
There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals.
CHOLSCAN will only be used in special controlled areas. This product must be handled and administered only by trained and qualified personnel experienced in the safe use of radiopharmaceuticals. These individuals will take special care in the safe handling of this product and will inform you about their actions.
The nuclear medicine physician supervising the procedure will determine the amount of CHOLSCAN to be used in your case. This will be the minimum quantity necessary to obtain the required diagnostic information.
The generally recommended dose ranges between 140 and 280 MBq (depending on the patient's body weight, 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 required by your physician.
After the injection, you must remain completely at rest, without reading or talking. In addition, you will be offered a drink and asked to empty your bladder immediately before the procedure begins.
Duration of the procedure
Your nuclear medicine physician will inform you about the usual duration of the procedure.
After receiving CHOLSCAN, you should:
- avoid direct contact with young children and pregnant women during the 12 hours following injection
- drink plenty of fluids and urinate frequently to help eliminate the product from your body.
The nuclear medicine physician will inform you if any special precautions are necessary after receiving this medicine. Please consult your nuclear medicine physician if you have any doubts.
If you have been given more CHOLSCAN than you should have received
An overdose is unlikely, as you will receive a single, precisely controlled dose of CHOLSCAN determined by the supervising nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be provided.
In particular, the nuclear medicine physician in charge of the procedure may recommend that you drink abundantly to facilitate the elimination of CHOLSCAN from your body (indeed, the main route of elimination for this product is renal, via urine).
If you have any further questions about the use of CHOLSCAN, please ask the nuclear medicine physician supervising the procedure.
4. Possible adverse effects
Like all medicines, this medicinal product may cause adverse effects, although not everyone will experience them.
Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation, with a very low risk of developing cancer and hereditary defects.
Reporting of adverse effects
If you experience any type of adverse effect, consult your nuclear medicine physician. This includes adverse effects not listed in this leaflet. You may also report them directly through the national reporting system included in the Spanish System for Pharmacovigilance of Human Medicines: www.notificaRAM.es.
By reporting adverse effects, you can help provide more information on the safety of this medicinal product.
5. Storage of CHOLSCAN
You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations regarding radioactive materials.
The following information is intended for specialists only.
Do not use this medicine after the expiry date stated on the container label following {DD MM YYYY hh:mm UTC}.
6. Package contents and other information
Composition of CHOLSCAN
- The active substance is fluorocholine chloride (18F): One ml of injectable solution contains 222 MBq of fluorocholine chloride (18F) at the date and time of calibration.
- The other excipients are sodium chloride 9 mg/ml and water for injections.
Presentation of the product and package contents
CHOLSCAN is a clear, colourless solution.
The activity per vial ranges between 111 MBq and 2220 MBq at the date and time of calibration.
Marketing Authorization Holder and Manufacturer
Marketing Authorization 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 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 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
For further information about this medicinal product, please contact 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 medicinal product is authorized 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 medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) (https://www.aemps.gob.es).
This information is intended exclusively for physicians or healthcare professionals:
The Summary of Product Characteristics for CHOLSCAN is provided as a separate document within the product packaging, 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 package).