Label: information for the patient

DOPACIS 90MBq/ml injectable solution

Fluorodopa(18F)

Read this label carefully before starting to use the medication, as it contains important information for you.

• Keep this label, 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 adverse effects,consultthe nuclear medicine specialist,eveniftheyare not listed in this label. See section 4.

1.What is Dopacis and how it is used

2.What you need to know before using Dopacis

3.How to use Dopacis

4.Possible adverse effects

5.Contents of the package and additional information

This medication 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 visualization of the organs that capture the fluorodopa(18F). In fact, after the injection of a small amount of Dopacis into a vein, the product can be easily detected in the 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 the effectiveness of treatment, according to images of all or part of your body.

You should not use Dopacis

• if you areallergicto fluorodopa (18F) or to any of the other components of this medication (listed in section 6).
• if you arepregnant.

Warnings and precautions

You should take special care with Dopacis

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

• if you arepregnantor think you may bepregnant,
• if you arebreastfeedingyour child,
• if you areunder 18 years old,
• if you have anyrenal problems,
• if you have had anyPET scansin the last 5 days,
• if you are taking anyantiparkinsonian medication,
• if you are taking anyglucagon medication(hypoglycemic agent).

Children and adolescents

If you are under 18 years old, consult your nuclear medicine specialist.

Use of DOPACIS with other medications

Inform your doctor or the nuclear medicine specialist who will perform your exam if you are using or have recently used other medications, even those purchased without a prescription, as they may interfere with the interpretation of your scan images:

• Carbidopa, entacapona, nitecapona
• Glucagon
• Haloperidol
• MAO inhibitors (monoamine oxidase)
• Reserpine

Use of 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 intend to become pregnant, consult your nuclear medicine specialistbefore using this medication.

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

If you are unsure, it is essential to consult your doctor or the nuclear medicine specialist who will perform your exam.

If you are pregnant,Dopacis is contraindicated during pregnancy.

If you are breastfeeding,,

The nuclear medicine specialist who will perform your exam will indicate when to resume breastfeeding.

You must interrupt breastfeeding for 12 hoursafter the injection and discard any milk expressed during this period.

Before using Dopacis, you must:

• be fasting for at least 4 hours, but you can drink water without limit
• interrupt any antiparkinsonian treatmentat least 12hours before a nuclear medicine PET scan.
• 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 young children for 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 radioactive pharmaceuticals. 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 individuals will take special care to use this product safely and will keep you informed of their actions.

Driving and operating machinery

The possibility of Dopacis affecting your ability to drive or operate machinery is very low.

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

The specialist nuclear medicine physician performing the examination will decide on the amount of Dopacis to be used in your case. It will be the minimum amount necessary to obtain the desired information. The recommended dose generally administered for an adult is 4MBq/kg of body weight. The activity can 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 physician will inject Dopacis slowly, over approximately one minute, into a vein in your arm. A single injection is sufficient to provide your physician with the necessary information.

Duration of the test

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

If you are administered more Dopacis than necessarythan necessary

A overdose is unlikely because you will only receive a single controlled dose of Dopacis administered by the specialist nuclear medicine physician performing the examination. However, in the event of an overdose, you will receive the appropriate treatment. Specifically, the specialist physician in charge of the procedure will recommend that you drink abundantly to facilitate the elimination of Dopacis from your body. In fact, this medication is primarily eliminated through the kidneys in the urine.

If you have any further questions about the use of Dopacis, consult your physician or specialist nuclear medicine physician performing the examination.

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

Sensation of burning, pain at the application site, pain, and heat at the application site have been reported. Reports indicate that pain at the injection site disappears spontaneously within a few minutes.

Only one case of 'carcinoid crisis' has been reported: nausea, vomiting, diarrhea, rapid pulse (tachycardia), hypotension, facial and chest flushing.

The administration of this radiopharmaceutical will involve the administration of a small amount of ionizing radiation with very low risk of cancer and hereditary 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 Adverse Effects

If you experience any type of adverse effect, consult your specialist in nuclear medicine,even if it is about 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 Use www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Composition of Dopacis

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

Appearance of Dopacis and contents of the container

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

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

CIS bio international

RN 306-Saclay

B.P. 32

F-91192 Gif-sur-Yvette Cedex

Responsible for manufacturing

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 medication by contacting the local representative of the holder of the marketing authorization:

Curium Pharma Spain, S.A.

Avda. Dr. Severo Ochoa, 29

28100 Alcobendas

Tfno.: 91 4841989

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

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

Fluorodopa ( 18 F) CIS bio international in Belgium.

Fluorodopa ( 18 F) Curium Italy in Italy.

Last review date of this prospectus: 08/2024

Other sources of information

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

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This information is intended solely for healthcare professionals:

The complete technical file of Dopacis is supplied 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.