FLUOROCOLINA (18F) CIS BIO INTERNATIONAL 225 MBq/mL INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

Fluorocoline (18F) CIS bio international 225 MBq/ml Solution for Injection

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 doctor or the nuclear medicine doctor who will be supervising the procedure.
• If you experience any side effects, talk to your doctor or the nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Fluorocoline (18F) CIS bio international and what is it used for
2. What you need to know before you are given Fluorocoline (18F) CIS bio international
3. How to use Fluorocoline (18F) CIS bio international
4. Possible side effects
5. Storage of Fluorocoline (18F) CIS bio international
6. Package Contents and Further Information

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

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

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

The active substance in Fluorocoline (18F) CIS bio international allows for the acquisition of images of certain parts of your body.

The purpose of this PET scan is to help decide how to treat the disease you are suffering from or are suspected to be suffering from.

Administration of fluorocoline (18F) involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will gain from this procedure with the radiopharmaceutical outweighs the risk due to radiation.

2. What you need to know before you are given Fluorocoline (18F) CIS bio international

Do not use Fluorocoline (18F) CIS bio international

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

Warnings and Precautions

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

• fast for at least 4 hours.
• drink plenty of water before starting the procedure so that you are well hydrated and urinate as frequently as possible during the first few hours after the procedure.

Children and Adolescents

Fluorocoline (18F) CIS bio international is not indicated in the pediatric population.

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

Tell your nuclear medicine doctor if you are taking, have recently taken, or might take any other medicines, as some medicines may interfere with the interpretation of the images by your doctor, in particular:

• if you are being treated with anti-androgen therapy.
• if you have been treated with 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 doctor who will be performing the PET procedure.

Use of Fluorocoline (18F) CIS bio international with food and drinks

You must fast for at least 4 hours before administration of Fluorocoline (18F) CIS bio international, as some foods may decrease the quality of the images.

Pregnancy and Breastfeeding

Fluorocoline (18F) CIS bio international is not indicated in women.

Driving and Using Machines

It is unlikely that Fluorocoline (18F) CIS bio international will affect your ability to drive or use machines.

Fluorocoline (18F) CIS bio international contains sodium

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

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

There are strict rules on the use, handling, and disposal of radiopharmaceuticals.

Fluorocoline (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 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 who supervises the procedure will decide the amount of Fluorocoline (18F) CIS bio international to be used in your case, which will be the minimum amount necessary to obtain the desired information.

Posology

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

The recommended activity ranges from 100 to 400 MBq for a 70 kg adult. MBq means megabecquerel, which is the unit used to express radioactivity.

Administration of Fluorocoline (18F) CIS bio international and Performance of the Procedure

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

A single injection is sufficient to perform the procedure your doctor needs.

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 doctor will inform you about the usual duration of the procedure.

After Administration of Fluorocoline (18F) CIS bio international, you must:

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

Your nuclear medicine doctor will indicate if you need to take any special precautions after receiving this medicine.

Consult your nuclear medicine doctor if you have any doubts.

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

Overdose is unlikely because you will receive a single, precisely controlled dose of Fluorocoline (18F) CIS bio international by the nuclear medicine doctor supervising the procedure.

However, in case of overdose, you will receive appropriate treatment. In particular, the nuclear medicine doctor in charge of the procedure will recommend that you drink plenty of water to facilitate the elimination of radioactivity from the body.

If you have any further questions about the use of Fluorocoline (18F) CIS bio international, ask your nuclear medicine doctor who supervises the procedure.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

To date, no side effects have been observed.

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 Spanish Medicines and Healthcare Products Agency's website www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

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

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.

6. Package Contents and Further Information

Composition of Fluorocoline (18F) CIS bio international

• The active substance is fluorocoline (18F). Each milliliter of solution for injection contains 225 MBq at the date and time of calibration.
• The other ingredients are sodium chloride and water for injections.

Appearance of the Product and Package Contents

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

Fluorocoline (18F) CIS bio international is a clear, colorless liquid.

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

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 ROME

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

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Curium Pharma Spain, S.A.

Avda. Dr. Severo Ochoa, 29

28100-Alcobendas

Phone: 91 4841989

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

Belgium, France, Luxembourg, Netherlands, and Malta: Fluorocholine (18F) CIS bio international

Portugal and Spain: Fluorocoline (18F) CIS bio international

Slovenia: [18F] Fluoroholin CIS bio international

Italy: Fluorocoline (18F) Curium Italy

Date of Last Revision of this Leaflet: January 2020

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

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This information is intended for healthcare professionals only:

The full summary of product characteristics of Fluorocoline (18F) CIS bio international is included as a separate document in the product packaging, 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 of the medicine.