Fluorocholine (18F) CIS bio international 225 MBq/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Fluorocholine (18F) CIS bio international 225 MBq/ml solution for injection

Fluorocholine (18F) chloride

Read all of this leaflet carefully before you are given 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, ask your doctor or the nuclear medicine physician who will supervise the procedure.
• If you experience any adverse reactions, consult the nuclear medicine physician, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Fluorocholine (18F) CIS bio international is and what it is used for
2. What you need to know before receiving Fluorocholine (18F) CIS bio international
3. How Fluorocholine (18F) CIS bio international is administered
4. Possible adverse effects
5. How to store Fluorocholine (18F) CIS bio international
6. Contents of the pack and other information

1. What Fluorocholine (18F) CIS bio international is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only. Fluorocholine (18F) CIS bio international contains the active substance fluorocholine (18F).

Fluorocholine (18F) CIS bio international is used in positron emission tomography (PET) procedures performed in adult males with prostate diseases.

The active substance in Fluorocholine (18F) CIS bio international allows imaging of certain parts of your body.

The purpose of this PET scan is to help determine how to treat the disease you have or are suspected to have.

Administration of fluorocholine (18F) involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will obtain from this radiopharmaceutical procedure outweighs the risk due to radiation exposure.

2. What you need to know before using Fluorocholine (18F) CIS bio international

Do not use Fluorocholine (18F) CIS bio international

• if you are allergic to fluorocholine (18F) or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant.

Warnings and precautions

Before administration of Fluorocholine (18F) CIS bio international you must:

• fast for at least 4 hours.
• drink plenty of water before starting the procedure to ensure adequate hydration, and urinate as frequently as possible during the first hours after the procedure.

Children and adolescents

Fluorocholine (18F) CIS bio international is not indicated in the paediatric population.

Use of Fluorocholine (18F) CIS bio international with other medicines

Inform your nuclear medicine physician if you are taking, have recently taken, or might need to take any other medicines, as certain medications may interfere with image interpretation by your physician, specifically:

• if you are undergoing antiandrogen therapy.
• if you have received chemotherapy.
• if you have been treated with medicines that increase blood cell production.
• if you have been treated with colchicine (e.g., to treat gout).

If you have any doubts, consult your nuclear medicine physician who will perform the PET procedure.

Use of Fluorocholine (18F) CIS bio international with food and drink

You must fast for at least 4 hours before administration of Fluorocholine (18F) CIS bio international, as certain foods may reduce image quality.

Pregnancy and breastfeeding

Fluorocholine (18F) CIS bio international is not indicated for use in women.

Driving and use of machines

It is unlikely that Fluorocholine (18F) CIS bio international will affect your ability to drive or operate machinery.

Fluorocholine (18F) CIS bio international contains sodium

This medicine contains sodium (3.54 mg/ml). Depending on the injected volume, the limit of 1 mmol (23 mg) of sodium per administered dose may be exceeded, which should be taken into account in patients on a low-sodium diet.

3. How to use Fluorocholine (18F) CIS bio international

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals.

Fluorocholine (18F) CIS bio international will only be used in special controlled areas. This medicine will only be handled and administered by trained and qualified personnel who are skilled in its safe use. These individuals will take special care in the safe handling of this product and will inform you of their actions.

The nuclear medicine physician supervising the procedure will determine the amount of Fluorocholine (18F) CIS bio international to be used in your case, which will be the minimum necessary to obtain the required diagnostic information.

Dosage

The administered amount is determined based on your body weight and depends on the type of imaging camera used to obtain images of your body.

The recommended activity ranges from 100 to 400 MBq for an adult weighing 70 kg. MBq stands for megabecquerel, the unit used to express radioactivity.

Administration of Fluorocholine (18F) CIS bio international and procedure performance

Fluorocholine (18F) CIS bio international is administered intravenously.

A single injection is sufficient to perform the procedure required by your physician.

After the injection, you will be offered a drink and asked to urinate immediately before starting the procedure.

Duration of the procedure

Your nuclear medicine physician will inform you about the typical duration of the procedure.

After administration of Fluorocholine (18F) CIS bio international you should:

• avoid direct contact with young children and pregnant women for 12 hours after the injection.
• urinate frequently to help eliminate the product from your body.

The nuclear medicine physician will inform you if you need to take any special precautions after receiving this medicine.

Consult your nuclear medicine physician if you have any questions.

If you are given more Fluorocholine (18F) CIS bio international than you should

An overdose is unlikely, as you will receive a single precisely controlled dose of Fluorocholine (18F) CIS bio international, administered under the supervision of the nuclear medicine physician.

However, in the event of an overdose, appropriate treatment will be provided. Specifically, the nuclear medicine physician in charge of the procedure will advise you to drink plenty of fluids to facilitate the elimination of radioactivity from your body.

If you have any further questions about the use of Fluorocholine (18F) CIS bio international, please consult your nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

To date, no adverse effects have been observed.

Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation, with a very low risk of developing cancer or hereditary defects.

Reporting of adverse effects

If you experience any type of adverse effect, consult your nuclear medicine physician, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fluorocholine (18F) CIS bio international

You will not be required to store this medicine. This medicine will be stored under the responsibility of a specialist in appropriate facilities. The storage of radiopharmaceuticals will comply with national regulations concerning radioactive materials.

6. Package contents and other information

Composition of Fluorocholine (18F) CIS bio international

• The active substance is fluorocholine (18F). Each millilitre of injectable solution contains 225 MBq at the reference date and time.
• The other components are sodium chloride and water for injectable preparations.

Appearance of the product and contents of the container

You will not have to store or handle this medicine. The following information is provided for your knowledge only.

Fluorocholine (18F) CIS bio international is a clear, colourless liquid.

The activity per vial ranges from 112 MBq to 3375 MBq at the reference date and time.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

CIS bio international
RN 306 SACLAY
BP 32
F-91192 GIF-SUR-YVETTE CEDEX

Manufacturer

CURIUM PET FRANCE
PARC SCIENTIFIQUE ET TECHNIQUE G. BESSE
180, ALLEE VON NEUMANN
30035 NÎMES CEDEX 1
FRANCE

CURIUM PET FRANCE
HÔPITAL XAVIER ARNOZAN
AVENUE DU HAUT LEVÊQUE
33600 PESSAC
FRANCE

CURIUM PET FRANCE
CENTRE EUGENE MARQUIS
AVENUE DE LA BATAILLE FLANDRES DUNKERQUE
35042 RENNES CEDEX
FRANCE

CURIUM PET FRANCE
10 AVENUE CHARLES PEGUY
95200 SARCELLES
FRANCE

CURIUM PET FRANCE
CHU DE BRABOIS
AVENUE DE BOURGOGNE
54500 VANDOEUVRE-LES-NANCY
FRANCE

CURIUM ITALY S.R.L.
VIA PERGOLESI 33,
20900 MONZA
ITALY

CURIUM ITALY S.R.L.
VIALE OXFORD 81,
00133 ROMA
ITALY

CURIUM ITALY S.R.L.
PIAZZALE SANTA MARIA DELLA MISERICORDIA 15,
33100 UDINE
ITALY

OFFICINA FARMACEUTICA
ISTITUTO DI FISIOLOGIA CLINICA DEL CNR
VIA MORUZZI, 1
56124 PISA
ITALY

SPARKLE S.R.L.
CONTRADA CALO’
73042 CASARANO (LE)
ITALY

CURIUM PHARMA SPAIN S.A.
PARQUE TECNOLÓGICO CARTUJA'93
AVDA. THOMAS ALVA EDISON 7
41092 SEVILLA
SPAIN

CURIUM PHARMA SPAIN S.A.
POL. IND. CONPISA, C/ VEGUILLAS 2- NAVE 16
28864 AJALVIR (MADRID)
SPAIN

B.V. CYCLOTRON VU
DE BOELELAAN 1081
1081 HV AMSTERDAM
THE NETHERLANDS

CYCLOTRON VU
VAN DER BOECHORSTSTRAAT 6A
1081 BT AMSTERDAM
THE NETHERLANDS

For further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Curium Pharma Spain, S.A.
Avda. Dr. Severo Ochoa, 29
28100 Alcobendas
Tel.: 91 4841989

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

Belgium, France, Luxembourg, the Netherlands and Malta: Fluorocholine (18F) CIS bio international
Portugal and Spain: Fluorocolina (18F) CIS bio international
Slovenia: [18F] Fluoroholin CIS bio international
Italy: Fluorocolina (18F) Curium Italy

Date of the most recent revision of this leaflet: January 2020

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.

This information is intended for healthcare professionals only:

The full Summary of Product Characteristics for Fluorocholine (18F) CIS bio international is included as a separate document in the product packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the product's Summary of Product Characteristics.