Patient Information Leaflet

Fluorocolina (18F) CIS bio international 225MBq/ml injectable solution

Fluorocolina (18F) chloride

Read this leaflet carefully before you receive this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or the nuclear medicine physician who will supervise the procedure.
• If you experience any side effects, consult the nuclear medicine physician,even if they are not listed in this leaflet. See section4.

1.What is Fluorocolina (18F) CIS bio international and how is it used

2.What you need to know before starting to use Fluorocolina (18F) CIS bio international

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

4.Possible side effects

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

6. Contents of the pack and additional information

This medication is a radiopharmaceutical for diagnostic use only.Fluorocolina (18F) CIS bio international contains the active ingredient fluorocolina (18F).

Fluorocolina (18F) CIS bio international is used in procedures performed using positron emission tomography (PET) in adult males suffering from prostate diseases.

The active ingredient of Fluorocolina (18F) CIS bio international allows for the acquisition of images of some parts of your body.

The performance of this PET examination aims to help decide the mode of treatment for the disease you suffer from or that is suspected to be suffered from.

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

No use Fluorocolina (18F) CIS bio international

-if you are allergic to fluorocolina (18F) or any of the other components of this medication (listed in section6).

-if you are pregnant.

Warnings and precautions

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

-fast for a minimum of 4hours.

-drink plenty of water before starting the procedure to ensure you are well hydrated and urinate as frequently as possible during the first hours after the procedure.

Children and adolescents

Fluorocolina (18F) CIS bio international is not indicated for pediatric patients.

Use of Fluorocolina (18F) CIS bio international with other medications

Inform your nuclear medicine physician if you are taking, have taken recently, or may need to take any other medication, as some medications may interfere with the interpretation of images by your physician, specifically:

• if you are being treated with an anti-androgen therapy.
• if you have been treated with chemotherapy.
• if you have been treated with medications 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 Fluorocolina (18F) CIS bio international with food and beverages

You must fast for a minimum of 4hours before administration of Fluorocolina (18F) CIS bio international, as some foods may reduce the quality of the images.

Pregnancy and lactation

Fluorocolina (18F) CIS bio international is not indicated for women.

Driving and operating machinery

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

Fluorocolina (18F) CIS bio international contains sodium

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

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

Fluorocolina (18F) CIS bio international will be used exclusively in special controlled areas.This medication will only be handled and administered by trained and qualified personnel to use it safely. These individuals will take special care in the safe use of this product and will inform you of their actions.

The nuclear physician overseeing the procedure will decide on the amount of Fluorocolina (18F) CIS bio international to be used in your case, which will be the minimum amount necessary to obtain the desired information.

Dosage

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

The recommended activity varies from 100 to 400 MBq for an adult weighing 70 kg. MBq stands for megabequerel, which is the unit used to express radioactivity.

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

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

One 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.

Procedure duration

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

After administration of Fluorocolina (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 physician will inform you if you need to take any special precautions after receiving this medication.

Consult with your nuclear physician if you have any doubts.

If you are administered more Fluorocolina (18F) CIS bio international than you should

A overdose is unlikely because you will receive a controlled and precise dose of Fluorocolina (18F) CIS bio international from the nuclear physician overseeing the procedure.

However, in case of an overdose, you will receive the appropriate treatment. Specifically, the nuclear physician responsible for the procedure will recommend that you drink abundantly to facilitate the elimination of radioactivity from your body.

If you have any other doubts about the use of Fluorocolina (18F) CIS bio international, ask your nuclear physician who oversees the procedure.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

To date, no adverse effects have been observed.

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary defects.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your nuclear physician,even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This medication does not need to be stored by you. This medication will be stored under the responsibility of the specialist in suitable facilities. Storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

Composition of Fluorocolina (18F) CIS bio international

• The active ingredient is fluorocolina (18F).Each milliliter of injectable solution contains 225 MBq at the date and time of calibration.
• The other components are sodium chloride and water for injection.

Appearance of the product and contents of the package

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

Fluorocolina (18F) CIS bio international is a transparent and colorless liquid.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

CIS bio international

RN 306 SACLAY

BP 32

F-91192 GIF-SUR-YVETTE CEDEX

Responsible for manufacturing

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

PHARMACEUTICAL MANUFACTURING

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 ÁMSTERDAM

NETHERLANDS

CYCLOTRON VU

VAN DER BOECHORSTSTRAAT 6A

1081 BT ÁMSTERDAM

NETHERLANDS

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

Curium Pharma Spain, S.A.

Avda. Dr. Severo Ochoa, 29

28100-Alcobendas

Tel.: 91 4841989

This medication is authorized in the member states of the European Economic Area with the following names:

Belgium, France, Luxembourg, 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

Last review date of this leaflet: January 2020

The detailed and updated information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

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This information is intended only for healthcare professionals:

The complete technical file of Fluorocolina (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 technical file of the medication.