Dopacis 90 MBq/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

DOPACIS 90 MBq/ml solution for injection

Fluorodopa (18F)

Read the entire leaflet carefully before you start using 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 specialist performing your examination.
• If you experience any adverse reactions, consult the Nuclear Medicine specialist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents:

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. Contents of the pack and other information

1. What Dopacis is and what it is used for

This medicine is a radiopharmaceutical and is used solely for diagnostic purposes.

Dopacis is a radioactive injectable solution of fluorodopa (18F). Fluorine (18F) is the radioactive element that allows visualization of organs that take up fluorodopa (18F). Indeed, after injection of a small amount of Dopacis into a vein, the product can be easily detected in your body using a camera capable of visualizing the radiation emitted by fluorine (18F).

Dopacis is used:

• to determine the location or progression of your disease, or
• to guide treatment decisions or to assess their effectiveness, based on images of all or part of your body.

2. What you need to know before using Dopacis

Never use Dopacis

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

Warnings and precautions

Take special care with Dopacis

If any of the following situations apply to you, you must inform the nuclear medicine specialist:

• if you are pregnant or think you may be pregnant,
• if you are breastfeeding your child,
• if you are under 18 years of age,
• if you have any kidney problems,
• if you have undergone any PET scan within the last 5 days,
• if you are taking any anti-Parkinson’s medications,
• if you are taking any glucagon-containing medications (hyperglycemic agents).

Children and adolescents

If you are under 18 years of age, consult your nuclear medicine specialist physician.

Use of DOPACIS with other medicines

Inform your doctor or the nuclear medicine specialist performing your examination if you are using or have recently used any other medicines, including those obtained without a prescription, as they may interfere with the interpretation of your scan images:

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

Use of Dopacis with food and drinks

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult the nuclear medicine specialist physician before using this medicine.

Nuclear medicine scans may pose a risk to the fetus. You must inform the nuclear medicine specialist before administration of Dopacis if there is any possibility you are pregnant, if you have missed your period, or if you are breastfeeding.

If you have any doubts, it is important that you consult your doctor or the nuclear medicine specialist performing your examination.

If you are pregnant, Dopacis is contraindicated during pregnancy.

If you are breastfeeding,

The nuclear medicine specialist performing your examination will advise you when you may resume breastfeeding.

You must interrupt breastfeeding for 12 hours after the injection, and breast milk expressed during this period should be discarded.

Before using Dopacis you must:

• fast for at least 4 hours, although you may drink unlimited amounts of water
• discontinue any anti-Parkinson’s treatment at least 12 hours before a neurological PET scan.
• drink plenty of water and remain well hydrated before starting the test to allow frequent urination during the first few hours after the test.

After administration of Dopacis you must:

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

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Dopacis will only be used in a hospital setting. Personnel handling and administering this product are trained and qualified to use it safely. These individuals will take special care to ensure safe use of the product and will keep you informed of their actions.

Driving and use of machines

The likelihood that Dopacis will affect your ability to drive or operate machinery is very low.

Dopacis contains less than 1 mmol of sodium (23 mg) per injection, i.e., it is "essentially sodium-free".

3. How to use Dopacis

The specialist physician in Nuclear Medicine performing the examination will determine the amount of Dopacis to be used in your case. This will be the minimum quantity necessary to obtain the desired information. The recommended administered activity is generally 4 MBq/kg of body weight in adults. The activity may be reduced by half in neurological indications where whole-body imaging is not required.

Use in children and adolescents

In the pediatric population, the administered amount will be adjusted according 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. A single injection is sufficient to provide your doctor with the necessary information.

Duration of the test

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

If you are given more Dopacis than you should

An overdose is unlikely, as you will receive only a single dose of Dopacis, carefully controlled by the specialist physician performing the examination. However, in the event of an overdose, appropriate treatment will be administered. Specifically, the physician in charge of the procedure will advise you to drink plenty of fluids to facilitate the elimination of Dopacis from your body. Indeed, this medicinal product is primarily eliminated via the kidneys in urine.

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

4. Possible adverse effects

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

Burning sensation, pain at the application site, and pain and warmth at the injection site have been reported. Reports indicate that injection site pain disappears spontaneously within a few minutes.

There has been only one reported case of 'carcinoid crisis': nausea, vomiting, diarrhoea, rapid pulse (tachycardia), hypotension, and redness of the face and chest.

Administration of this radiopharmaceutical will involve exposure to a small amount of ionizing radiation, carrying a very low risk of cancer and hereditary abnormalities.

Your doctor has determined that the clinical benefit you will obtain from the procedure using the radiopharmaceutical outweighs the risk due to radiation exposure.

Reporting of adverse effects

If you experience any type of adverse effect, consult your specialist in nuclear medicine, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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. Conservation of

6. Contents of the pack and other information

Composition of Dopacis

• The active substance is fluorodopa (18F): 90 MBq/mL (at the calibration date and time).
• The other components are: acetic acid, ascorbic acid, sodium acetate, disodium edetate, water for injectable preparations.

Appearance of Dopacis and contents of the container

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

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

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

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

This medicinal product is authorized in the European Economic Area member states under the following names:

DOPACIS in France, Luxembourg, Malta, the Netherlands, Portugal, Slovenia, and Spain.

Fluorodopa (18F) CIS bio international in Belgium.

Fluorodopa (18F) Curium Italy in Italy.

Date of the most recent review of this summary of product characteristics: 08/2024

Other sources of information

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es).

This information is intended for healthcare professionals only:

The full product information (SmPC) of Dopacis is supplied as a separate document within the product pack, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the product information (SmPC).