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CHOLSCAN 222 MBq/mL INJECTABLE SOLUTION

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About the medicine

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

  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.

Doctor consultation

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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.

Medicine questions

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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).

Online doctors for CHOLSCAN 222 MBq/mL INJECTABLE SOLUTION

Discuss questions about CHOLSCAN 222 MBq/mL INJECTABLE SOLUTION, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Томаш Гжеловський

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques.

For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance.

Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults.

In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions.

Patients commonly seek his care for:

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns
Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.
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Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
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  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
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  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
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Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
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Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Doctor

Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
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  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
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  • Cardiovascular health: hypertension, cholesterol control, risk assessment for heart disease.
  • Preventive medicine: regular check-ups, health screenings, long-term management of chronic conditions.

Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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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.
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.
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