DOPACIS 90 MBq/ml INJECTABLE SOLUTION

Introduction

Patient Information Leaflet

DOPACIS 90MBq/ml injectable solution

Fluorodopa (18F)

Read this leaflet carefully before starting to use the 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 specialist who will perform your examination.
• If you experience side effects, consult the Nuclear Medicine specialist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet:

1. What Dopacis is and what it is used for
2. What you need to know before using Dopacis
3. How to use Dopacis
4. Possible side effects
5. Package contents and additional information

1. What Dopacis is and what it is used for

This medicine is a radiopharmaceutical used solely for diagnostic purposes.

Dopacis is a radioactive injectable solution of fluorodopa (18F). The fluorine (18F) is the radioactive element that allows the organs that capture the fluorodopa (18F) to be visualized. In fact, after the injection of a small amount of Dopacis into a vein, the product can be easily detected in your body using a camera that can visualize the radiation emitted by the fluorine (18F).

Dopacis is used:

• to determine the location or progression of your disease, or
• to guide treatment decisions or to examine their effectiveness, in accordance with images of all or part of your body.

2. What you need to know before using Dopacis

Do not use Dopacis

• if you are allergicto fluorodopa (18F) or to any of the other components of this medicine (listed in section 6).
• if you are pregnant.

Warnings and precautions

Be careful with Dopacis

If any of these situations apply to you, you must inform the Nuclear Medicine specialist:

• if you are pregnantor think you may be pregnant,
• if you are breastfeedingyour child,
• if you are under 18 years old,
• if you have any kidney problems,
• if you have had a PET scanin the last 5 days,
• if you are taking any anti-Parkinson's medication,
• if you are taking any medication with glucagon(hyperglycemic agent).

Children and adolescents

If you are under 18 years old, consult your doctor or Nuclear Medicine specialist.

Using DOPACIS with other medicines

Tell your doctor or the Nuclear Medicine specialist who will perform your examination if you are using or have recently used other medicines, including those purchased without a prescription, as they may interfere with the interpretation of your examination images:

• Carbidopa, entacapone, nitecapone
• Glucagon
• Haloperidol
• MAO inhibitors (monoamine oxidase)
• Reserpine

Using Dopacis with food and drinks

You will be asked not to eat anything for at least 4 hoursbefore the test; however, you will be asked to drink plenty of water.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or Nuclear Medicine specialist before using this medicine.

Nuclear Medicine examinations may involve a risk to the fetus. You must inform the doctor or Nuclear Medicine specialist before the administration of Dopacis if there is a possibility that you are pregnant, if you have missed your period, or if you are breastfeeding.

If you have any doubts, it is essential that you consult your doctor or the Nuclear Medicine specialist who will perform your examination.

If you are pregnant,Dopacis is contraindicated in pregnancy.

If you are breastfeeding,

The Nuclear Medicine specialist who will perform your examination will indicate when to resume breastfeeding.

You will need to interrupt breastfeeding for 12 hoursafter the injection, and the milk expressed during this period must be discarded.

Before using Dopacis, you must:

• fast for at least 4 hours, but you can drink water without limit
• stop any anti-Parkinson's treatmentat least 12 hoursbefore a neurological PET examination.
• drink plenty of water and be well-hydrated before starting the test to be able to urinate frequently during the first hours after the test.

After the administration of Dopacis, you must:

• avoid direct contactwith small children during the first 12 hours after the injection.
• urinate frequently to eliminate the product from your body.

There are strict laws regarding the use, handling, and disposal of radiopharmaceuticals. Dopacis will only be used in a hospital. The people who handle and administer this product are trained and qualified to use it safely. These people will take special care to use this product safely and will keep you informed of their actions.

Driving and using machines

The possibility of Dopacis affecting your ability to drive or use machines is very low.

Dopacis containsless than 1 mmol of sodium (23 mg) per injection, i.e., it is “essentially sodium-free”.

3. How to use Dopacis

The Nuclear Medicine specialist who will perform your examination will decide the amount of Dopacis to be used in your case. It will be the minimum amount necessary to obtain the desired information. The recommended amount administered is usually 4 MBq / kg of body weight. The activity may be reduced by half in neurological indications where whole-body images will not be obtained.

Use in children and adolescents

In the pediatric population, the amount to be administered will be adapted to the child's body weight.

Administration of Dopacis and performance of the examination

Your doctor will slowly inject Dopacis into a vein in your arm over approximately one minute. One injection is sufficient to provide your doctor with the necessary information.

Duration of the test

Your doctor will inform you of the usual duration of the test.

If you are given more Dopacis than necessary

Overdose is unlikely because you will only receive a single controlled dose of Dopacis from the Nuclear Medicine specialist who will perform your examination. However, in case of an overdose, you will receive the appropriate treatment. In particular, the Nuclear Medicine specialist in charge of the procedure will recommend that you drink plenty of water to facilitate the elimination of Dopacis from your body. This medicine is mainly eliminated through the kidneys in the urine.

If you have any further questions about the use of Dopacis, consult your doctor or the Nuclear Medicine specialist who will perform your examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Reports have included a burning sensation, pain at the injection site, pain, and heat at the injection site. Reports indicate that the pain at the injection site disappears spontaneously within a few minutes.

Only one case of 'carcinoid crisis' has been reported: nausea, vomiting, diarrhea, rapid heartbeat (tachycardia), low blood pressure, flushing of the face and chest.

The administration of this radiopharmaceutical will result in the administration of a small amount of ionizing radiation with a very low risk of cancer and genetic abnormalities.

Your doctor has considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk due to radiation.

Reporting side effects

If you experience any side effects, consult your Nuclear Medicine specialist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage

6. Package contents and additional information

Composition of Dopacis

• The active ingredient isfluorodopa (18F): 90 MBq / ml (at the date and time of calibration).
• The other ingredients are: acetic acid, ascorbic acid, sodium acetate, disodium edetate, water for injectable preparations.

Appearance of Dopacis and package contents

You will not have to handle the package or vial; the following is for information only.

The activity per vial varies from 90 MBq to 900 MBq at the date and time of calibration.

Marketing authorization holder and manufacturer

Marketing authorization holder

CIS bio international

RN 306-Saclay

B.P. 32

F-91192 Gif-sur-Yvette Cedex

Manufacturer

CURIUM PET FRANCE

Hôpital Xavier Arnozan

Avenue du Haut Lévèque

F-33600 Pessac

CURIUM PET FRANCE

Centre Eugène Marquis

Avenue de la Bataille Flandres Dunkerque

Bat 70 - CS44229

F-35042 Rennes Cedex

CURIUM PET FRANCE

10 avenue Charles Péguy

F-95200 Sarcelles

CURIUM PET FRANCE

CHU de Brabois

Avenue de Bourgogne

F-54500 Vandœuvre-lès-Nancy

CURIUM PET FRANCE

Technopôle de Château Gombert,

Rue Louis Leprince Ringuet

F-13013 Marseille

Curium Italy S.R.L.

Via Pergolesi 33

I-20900 Monza

Curium Italy S.R.L.

Viale Oxford 81,

I-00133 Roma

Curium Italy S.r.l.

Piazzale Santa Maria Della Misericordia, 15

I-33100 Udine

CURIUM PET FRANCE

Parc scientifique Georges Besse,

180 allée Von Neumann,

F-30000 NIMES

FRANCE

Curium Pharma Spain, S.A.

C/ Manuel Bartolomé Cossío, 10

E-28040 Madrid

Curium Pharma Spain, S.A.

Parque Tecnológico Cartuja’93

Avda. Thomas Alva Edison, 7

E-41092 Sevilla

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:

DOPACISin France, Luxembourg, Malta, Netherlands, Portugal, Slovenia, and Spain.

Fluorodopa (18F) CIS bio internationalin Belgium.

Fluorodopa (18F) Curium Italyin Italy.

Date of last revision of this leaflet: 08/2024

Other sources of information

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

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This information is intended only for healthcare professionals:

The complete technical data sheet for Dopacis is provided as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information about the administration and use of this radiopharmaceutical.

Please consult the technical data sheet.