CHOLSCAN 222 MBq/mL INJECTABLE SOLUTION
How to use CHOLSCAN 222 MBq/mL INJECTABLE SOLUTION
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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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
- What CHOLSCAN is and what it is used for
- What you need to know before you are given CHOLSCAN
- How CHOLSCAN is used
- Possible side effects
- Storage of CHOLSCAN
- 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).
- Country of registration
- Dosage formINJECTABLE, 222 MBq/ml
- ATC codeV09IX07
- Active substance
- Prescription requiredYes
- Manufacturer
- CompositionCLORURO DE SODIO (9 mg mg)
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to CHOLSCAN 222 MBq/mL INJECTABLE SOLUTIONDosage form: INJECTABLE, 225 MBq/mlActive substance: fluorocholine (18F)Manufacturer: Cis Bio InternationalPrescription requiredDosage form: INJECTABLE, 74 MBq iobenguane (123I)Active substance: iobenguane (123I)Manufacturer: Ge Healthcare Bio-Sciences, S.A.U.Prescription requiredDosage form: INJECTABLE, 1600 MBq/mlActive substance: fluciclovine (18F)Manufacturer: Blue Earth Diagnostics Ireland LimitedPrescription required
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Frequently Asked Questions
Is a prescription required for CHOLSCAN 222 MBq/mL INJECTABLE SOLUTION?
CHOLSCAN 222 MBq/mL INJECTABLE SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in CHOLSCAN 222 MBq/mL INJECTABLE SOLUTION?
The active ingredient in CHOLSCAN 222 MBq/mL INJECTABLE SOLUTION is fluorocholine (18F). This information helps identify medicines with the same composition but different brand names.
Who manufactures CHOLSCAN 222 MBq/mL INJECTABLE SOLUTION?
CHOLSCAN 222 MBq/mL INJECTABLE SOLUTION is manufactured by Advanced Accelerator Applications Molecular Imaging France. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of CHOLSCAN 222 MBq/mL INJECTABLE SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether CHOLSCAN 222 MBq/mL INJECTABLE SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
How to buy CHOLSCAN 222 MBq/mL INJECTABLE SOLUTION in Spain?
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy CHOLSCAN 222 MBq/mL INJECTABLE SOLUTION in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
What are the alternatives to CHOLSCAN 222 MBq/mL INJECTABLE SOLUTION?
Other medicines with the same active substance (fluorocholine (18F)) include FLUOROCOLINA (18F) CIS BIO INTERNATIONAL 225 MBq/mL INJECTABLE SOLUTION, ADREVIEW 74 MBq/ml INJECTABLE SOLUTION, AXUMIN 1600 MBq/ML INJECTABLE SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
