CHOLSCAN 222 MBQ/ML Injectable solution

Зміст інструкції

1. CHOLSCAN 222 MBq/mL injectable solution
   1. What is CHOLSCAN and what is it used for
   2. What you need to know before you take CHOLSCAN
   3. How to take CHOLSCAN
   4. Possible side effects
   5. How to store CHOLSCAN
   6. Contents of the pack and other information

CHOLSCAN 222 MBq/mL injectable solution

Fluorocholine (F) chloride

Read this leaflet carefully before you start to use this medicine as it contains important information for you

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask the nuclear medicine doctor who will supervise the entire procedure.
• If any side effects occur, including any not listed in this leaflet, tell your nuclear medicine doctor. See section 4.

Contents of this leaflet

• 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 administered
• 4. Possible side effects
• 5. How to store CHOLSCAN
• 6. Contents of the pack and other information

1. What is CHOLSCAN and what is it used for

This medicine is a radiopharmaceutical for diagnostic use only.
CHOLSCAN is used by doctors for diagnostic purposes during a medical imaging procedure called positron emission tomography (PET) and is
administered before performing this examination.
After injecting a small amount of CHOLSCAN, the images obtained with a special
machine will allow the doctor to see where your disease is located or how it is
progressing
The use of CHOLSCAN involves exposure to small doses of radioactivity. Your doctor and the
nuclear medicine specialist have deemed that the clinical benefit you will obtain from the procedure
outweighs the risks due to radiation.
The active substance contained in CHOLSCAN is fluorocholine (F) chloride, designed for
the acquisition of diagnostic images of some parts of the body.

2. What you need to know before you take CHOLSCAN

Do not take CHOLSCAN

• if you are allergic to fluorocholine (F) chloride or to any of the other ingredients 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 you take CHOLSCAN you must:

• drink plenty of water before starting the examination, so as to urinate as frequently as possible during the first 4 hours after the study
• be fasting for at least 4 hours before administration
• avoid any significant physical activity

Children and adolescents
CHOLSCAN is not intended for use in children and adolescents under the age of 18 years.

Other medicines and CHOLSCAN
Tell the nuclear medicine specialist if you are taking, have recently taken, or
may take any other medicines, as other medicines may interfere with
the interpretation of the images; in particular if you are undergoing anti-androgenic therapy,
anti-mitotic chemotherapy (colchicine or other), or any other treatment containing factors
stimulating hematopoiesis.
If you have any doubts, consult the nuclear medicine specialist who will preside over
the procedure for further information.

CHOLSCAN with food and drink
Before administering the product, due to the possible degradation of the images
due to certain foods, you must remain fasting for at least 4 hours. It is necessary to drink plenty of water.

Pregnancy and breastfeeding
CHOLSCAN is not indicated for use in women.

Driving and operating machinery
The effects on the ability to drive and operate machinery have not been studied. However, it is
unlikely that CHOLSCAN may affect your ability to drive or operate
machinery.

CHOLSCAN contains sodium
This medicine may contain more than 1 mmol of sodium (23 mg). This should be taken into
consideration in case of a low-sodium diet.

3. How to take CHOLSCAN

There are very strict laws regulating the use, handling and disposal of
radiopharmaceuticals.
CHOLSCAN must only be used in special controlled areas. This product will be handled and
administered exclusively by trained and qualified personnel, capable of using it safely. Such personnel will pay particular attention to using this medicine safely and will keep you informed about the procedures performed.
The nuclear medicine physician presiding over the procedure will decide the amount of CHOLSCAN to
use in your case. However, it will always be the minimum amount necessary to obtain the desired
information.
The recommended activity ranges from 140 to 280 MBq (depending on the patient's body weight, the type
of equipment used for image recording and the acquisition mode). The megabecquerel (MBq) is the unit of measure for radioactivity.

Administration of CHOLSCAN and performance of the procedure
CHOLSCAN is injected directly into a vein.
One injection is sufficient to perform the examination the doctor needs.
After the injection, it is necessary to remain completely at rest, without reading or talking. In addition, you
will be offered something to drink and asked to urinate immediately before the procedure.

Duration of the procedure
The nuclear medicine physician will inform you about the normal duration of the procedure.

After the administration of CHOLSCAN, you must:

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

The nuclear medicine physician will inform you if you are required to adopt specific
precautions after receiving this medicine. If you have any questions, please contact the specialist
nuclear medicine physician.

If you have been given more CHOLSCAN than you should
Since you will only receive a single dose of CHOLSCAN under controlled conditions by the specialist
nuclear medicine physician presiding over the procedure, the possibility of an overdose is unlikely.
However, in the event of an overdose, you will receive appropriate treatment.
In particular, the nuclear medicine physician responsible for the procedure may recommend that you drink
plenty of fluids to facilitate the elimination of CHOLSCAN from the body (in fact, the main route of
excretion of this product is renal, through urine).
If you have any doubts about the use of CHOLSCAN, please contact the nuclear medicine physician
presiding over the procedure.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
This radiopharmaceutical will deliver low doses of ionising radiation associated with a minimal risk of
cancer and hereditary abnormalities.
If you experience any side effects, including those not listed in this leaflet, please
consult your nuclear medicine physician.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please consult
your nuclear medicine physician. You can also report side effects directly via the
web: www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of
this medicine.

5. How to store CHOLSCAN

Do not store this medicine. The responsibility for storing this medicine is
delegated to the specialist in suitable premises. The storage of radiopharmaceuticals must comply
with national regulations on radioactive materials.
The following information is intended for the specialist only.
Do not use this medicine after the expiry date which is stated on the label after {DD MM
YYYY hh:mm UTC}.

6. Contents of the pack and other information

What CHOLSCAN contains

• The active substance is fluorocholine ( F) chloride: 1 mL of injectable solution contains 222 MBq of fluorocholine ( F) chloride at the date and time of calibration.
• The other ingredients are sodium chloride 9 mg/mL and water for injections

Description of the appearance of CHOLSCAN and contents of the pack
CHOLSCAN is a clear and colourless solution.
The activity per vial ranges from 111 MBq to 2,220 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

Manufacturers
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 Ibérica SLU
Polígono Industrial La Cuesta-Sector-3. Parcelas 1-2, La Almunia de Doña Godina,
50100 Zaragoza,
Spain

Advanced Accelerator Applications Molecular Imaging Ibérica S.L.U.
C/ Josep Anselm Clavé, 100
08950 Esplugues de Llobregat (Barcelona)
Spain

Advanced Accelerator Applications Molecular Imaging Ibérica S.L.U.
Hospital Clìnico Universitario Virgen de la Arrixaca
Ctra. Madrid-Cartagena, s/n
30120 El Palmar (Murcia)
Spain

Advanced Accelerator Applications (Italy) S.r.l.
Via Ribes 5
10010 Colleretto Giacosa (TO)
Italy

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

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
France, Austria, Germany, Luxembourg, Poland: FLUOROCHOL
Belgium, Italy, Lithuania, Spain, Netherlands: CHOLSCAN
Portugal: CHOLVIEW

Other sources of information
More detailed information on this medicine is available on the website of the Italian Medicines Agency:
http://www.agenziafarmaco.gov.it .
The following information is intended exclusively for healthcare professionals:
The Summary of Product Characteristics of CHOLSCAN is included as a
separate document in the medicine pack, with the aim of providing healthcare professionals
with additional scientific and practical information for the administration and use of this
radiopharmaceutical.
Please refer to the Summary of Product Characteristics (the Summary of
Product Characteristics must be included in the pack).