Fluorodopa (18F) Curium Austria

PACKAGE LEAFLET

Package leaflet: information for the patient

Fluorodopa ( F) Curium Austria 0.3 GBq/mL, solution for injection

6-fluoro-( F)-L-dihydroxyphenylalanine (or 6-fluoro-( F)-L-dopa)
Please read 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 the nuclear medicine physician who will supervise the procedure.
• If you experience any side effects, including those not listed in this leaflet, inform the nuclear medicine physician.

Contents of this leaflet:

1. What Fluorodopa ( F) Curium Austria is and what it is used for
2. What you need to know before Fluorodopa ( F) Curium Austria is administered to you
3. How Fluorodopa ( F) Curium Austria will be administered to you
4. Possible side effects
5. How to store Fluorodopa ( F) Curium Austria
6. Contents of the pack and other information

1. What Fluorodopa (F) Curium Austria is and what it is used for

This medicinal product is a radiopharmaceutical for diagnostic use only.
Fluorodopa (F) Curium Austria is used for diagnosis in Positron Emission Tomography (PET) scans and is administered prior to such examination.
The radioactive substance contained in Fluorodopa (F) Curium Austria (to visualize dopamine metabolism) is detected by PET and displayed in an image.
Positron Emission Tomography is an imaging technology used in nuclear medicine that produces images of cross-sectional sections of living organisms. It works by using small amounts of radioactive medicinal products to generate quantitative and precise images of specific metabolic processes in the body. This examination is performed to help determine how to treat the disease you have or are suspected of having.

2. What you should know before being administered Fluorodopa (F) Curium Austria

You will not be given Fluorodopa (F) Curium Austria

• if you are allergic (hypersensitive) to 6-fluoro-(F)-L-dopa or to any of the other ingredients of Fluorodopa (F) Curium Austria or to any of the other components of the medicinal product prepared prior to administration (see section 6).
• if you are pregnant.

Warnings and precautions
Exercise particular caution with Fluorodopa (F) Curium Austria and consult the nuclear medicine physician before administration in the following cases:

• if you are pregnant or suspect you might be pregnant,
• if you are breastfeeding.
• if you suffer from Parkinson's disease or are taking medications for the treatment of Parkinson's disease.

Before administration of Fluorodopa (F) Curium Austria, you must:

• Drink plenty of water before the examination begins, so as to urinate as frequently as possible during the first hours after the study.
• Fast for at least 4 hours.

Children and adolescents
Consult the nuclear medicine physician if you are under 18 years of age.
Other medicines and Fluorodopa (F) Curium Austria
Inform the nuclear medicine physician supervising the procedure if you are taking or have recently taken any other medicines, including those obtained without a prescription, as they might interfere with image interpretation.

• Medications for the treatment of Parkinson's disease: if you are taking medications for Parkinson's disease, it is recommended to discontinue treatment at least 12 hours before the PET examination.
• Carbidopa (anti-Parkinson drug)
• Haloperidol (active substance used for psychotic symptoms, e.g. in psychiatric disorders and confusional states)
• MAO inhibitors (Monoamine Oxidase inhibitors) (antidepressant drugs)
• Reserpine (active substance used to reduce arterial blood pressure)

Fluorodopa (F) Curium Austria with food and drinks
You are advised to fast for at least 4 hours before administration of Fluorodopa (F) Curium Austria.
To obtain high-quality images and reduce radiation exposure to the bladder, it is recommended to drink plenty of fluids before and after the examination (water and unsweetened tea are allowed) and to empty the bladder frequently.
Pregnancy and breastfeeding
If you are pregnant, suspect you might be pregnant, plan to become pregnant, or are breastfeeding, consult your nuclear medicine physician before receiving this medicinal product.
You must inform the nuclear medicine physician before administration of Fluorodopa (F) Curium Austria if there is any possibility you might be pregnant, if you have missed a menstrual period, or if you are breastfeeding.
If in doubt, it is important to consult the nuclear medicine physician supervising the procedure.
If you are pregnant
Fluorodopa (F) Curium Austria must not be used during pregnancy.
If you are breastfeeding
If you are breastfeeding, breast milk may be expressed and stored before the injection for later use. Breastfeeding must be interrupted for at least 12 hours. Milk produced during this period must be discarded.
Ask your nuclear medicine physician when you can resume breastfeeding.
Driving and using machines
Fluorodopa (F) Curium Austria is unlikely to affect your ability to drive or operate machinery.
Fluorodopa (F) Curium Austria contains sodium and ethanol
This medicinal product contains more than 1 mmol of sodium (23 mg). This should be taken into account if you are on a low-sodium diet.
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.

3. How Fluorodopa (F) Curium Austria will be administered to you

There are strict regulations governing the use, handling, and disposal of radiopharmaceuticals.
Fluorodopa (F) Curium Austria will only be used in a hospital setting. This product will be handled and
administered exclusively by trained and qualified personnel experienced in its use and familiar with safety procedures.
These individuals will pay particular attention to the safe use of this product and will keep you informed about their actions.
The nuclear medicine physician supervising the procedure will determine the amount of Fluorodopa (F)
Curium Austria to be used in your case. The smallest necessary amount required to obtain the desired diagnostic information will be administered.

Adults
In oncology: the generally recommended administered activity is 2–4 MBq/kg
(megabecquerel, the unit used to measure radioactivity), depending on the patient's body weight, the PET(/CT) equipment used, and the imaging protocol.
In neurology: the dose may be reduced (1–2 MBq/kg body weight) for neurological examinations,
such as in disorders of the nervous system where whole-body imaging is not required.

Use in children and adolescents
There is limited clinical data on the use of this medicinal product in children and adolescents under 18 years of age.
If used in children and adolescents, the administered amount will be adjusted according to the child's body weight.

Administration of Fluorodopa (F) Curium Austria and procedure performance
Fluorodopa (F) Curium Austria is administered by slow intravenous injection lasting approximately one minute.
A single injection is sufficient to perform the examination required by the physician.
After the injection, you will be asked to drink fluids and to urinate immediately before the procedure.

Duration of the procedure
The nuclear medicine physician will inform you about the usual duration of the procedure.

After receiving Fluorodopa (F) Curium Austria, you must:

• avoid close contact with young children and pregnant women during the first 12 hours after injection
• urinate frequently to help eliminate the product from your body

The nuclear medicine physician will inform you if any special precautions are necessary after receiving the medicinal product. Please consult the nuclear medicine physician for any further questions.

If you have been given more Fluorodopa (F) Curium Austria than you should have received
Overdose is unlikely, as you will receive only a single dose of Fluorodopa (F) Curium Austria, carefully controlled by the supervising nuclear medicine physician.
However, in the event of an overdose, appropriate treatment will be given. Elimination of the radioactive components should be enhanced as much as possible. You should drink as much fluid as possible and empty your bladder frequently. Diuretics may be required.

If you have any further questions about the use of Fluorodopa (F) Curium Austria, please consult the nuclear medicine physician supervising the procedure.

4. Possible side effects

Like all medicines, Fluorodopa (F) Curium Austria can cause side effects, although not everyone gets them.
The adverse events reported are listed below by system organ class and with an unknown frequency (cannot be estimated from the available data):

Rarely, pain at the injection site has been reported, which resolved within a few minutes without any intervention.
The radiopharmaceutical emits low levels of ionizing radiation, posing a very low risk of cancer and hereditary abnormalities.
The nuclear medicine physician has determined that the clinical benefit obtained from the procedure using the radiopharmaceutical outweighs the risk associated with radiation exposure.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your nuclear medicine physician. You may also report adverse reactions directly through the national reporting system at https://www.aifa.gov.it/en/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Fluorodopa ( F) Curium Austria

Do not store this medicinal product. This medicinal product will be stored under the responsibility of a specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended exclusively for specialists.
Fluorodopa ( F) Curium Austria must not be used after the expiry date stated on the label.

6. Package contents and other information

What Fluorodopa (F) Curium Austria contains

• The active substance is 6-fluoro-(F)-L-dihydroxyphenylalanine (or 6-fluoro-(F)-L-dopa). Each mL of the medicinal product contains 0.3 GBq of 6-fluoro-(F)-L-dihydroxyphenylalanine (or 6-fluoro-(F)-L-dopa) at the date and time of calibration.
• The other ingredients are sodium acetate trihydrate, acetic acid, disodium edetate dihydrate, ascorbic acid, citric acid, trisodium citrate dihydrate, sodium chloride, ethanol, and water for injections.

Description of the appearance of Fluorodopa (F) Curium Austria and contents of the pack
Fluorodopa (F) Curium Austria is a clear, colourless or slightly yellowish solution. The total activity of the vial at the date and time of calibration ranges between 0.15 and 6.0 GBq.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Curium Austria GmbH
Grazer Strasse 18
A-8071 Hausmannstaetten
Austria
Tel.: 0043-(0)316-284 300
Fax: 0043-(0)316-284 300-114
E-mail: [email protected]

Manufacturers
Curium Austria GmbH
St. Veiterstr. 47
9020 Klagenfurt
Austria
Curium Austria GmbH
Seilerstaette 4
4020 Linz
Austria
Advanced Accelerator Applications SA
Technopole de l’Aube
14 rue Gustave Eiffel
10430 Rosières-près-Troyes
France
Advanced Accelerator Applications s.r.l
Via Ribes, 5
10010 Colleretto Giacosa (TO)
Italy

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
France: IASOdopa 0.3 GBq/mL, solution for injection.
Austria: IASOdopa 0.3 GBq/mL - Injektionslösung
Germany: IASOdopa 0.3 GBq/mL, Injektionslösung
Italy: Fluorodopa (F) Curium Austria 0.3 GBq/mL, solution for injection

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (https://www.aifa.gov.it).

The following information is intended exclusively for physicians or healthcare professionals:
The full text of the Summary of Product Characteristics (SmPC) for Fluorodopa (F) Curium Austria is included in the package as a separate document, intended to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Please refer to the SmPC (which must be included in the package).