Fluorodopa (18F) Curium Italy

Package leaflet: Information for the patient

Fluorodopa ( F) Curium Italy 90 MBq/mL solution for injection

Fluorodopa ( F)
Please read this leaflet carefully before this medicine is administered to you
because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or the nuclear medicine specialist supervising the examination.
• If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine specialist. See section 4.

Contents of this leaflet:

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

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

This medicinal product is a radiopharmaceutical for diagnostic use only.
Fluorodopa (F) Curium Italy is a radioactive injectable solution of fluorodopa (F). Fluorine (F) is a radioactive element that allows visualization of the organs that take up fluorodopa (F). Indeed, after injection of a small amount of Fluorodopa (18F) Curium Italy into a vein, the product can be easily localized within your body using a special machine (PET scanner), which enables visualization of the radiation emitted by fluorine (F).
Fluorodopa (F) Curium Italy is used in the following cases:

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

2. What you must know before receiving Fluorodopa (F) Curium Italy

Never take Fluorodopa (F) Curium Italy

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

Warnings and precautions
Exercise particular caution with Fluorodopa (F) Curium Italy
Inform the nuclear medicine specialist in the following cases:

• if you are pregnant or suspect you may be pregnant,
• if you are breastfeeding,
• if you are under 18 years of age,
• if you have kidney problems,
• if you have undergone a PET scan within the last 5 days,
• if you are taking any anti-Parkinson’s medication,
• if you are undergoing any treatment with glucagon (a hyperglycaemic agent).

Children and adolescents
Consult the nuclear medicine physician if you are under 18 years of age.
Other medicines and Fluorodopa (F) Curium Italy
Inform your doctor or the nuclear medicine specialist performing your examination if you are taking or have
recently taken any other medicines, including those without a prescription, as they may interfere with the
interpretation of images by the physician:

• Carbidopa, entacapone, nitecapone
• Glucagon
• Haloperidol
• MAO inhibitors (monoamine oxidase inhibitors)
• Reserpine
  Fluorodopa (F) Curium Italy, food and drink

You will be asked to refrain from eating for at least 4 hours before the examination; however, you will be encouraged to drink
plenty of water.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, please consult your nuclear medicine physician before receiving this medicine.
Nuclear medicine procedures may pose a potential risk to the fetus. Inform the nuclear medicine specialist before administration of Fluorodopa (F) Curium Italy if there is any possibility you may be pregnant, if you have missed a menstrual period, or if you are breastfeeding.
If in doubt, it is important that you consult your physician or the nuclear medicine specialist supervising your examination.
If you are pregnant, please be aware that Fluorodopa (F) Curium Italy is contraindicated during pregnancy.
If you are breastfeeding,
Resumption of breastfeeding should be discussed with the nuclear medicine specialist performing your examination.
You must suspend breastfeeding for 12 hours after the injection, and the milk produced during this time must be discarded.
Before administration you must:

• fast for at least 4 hours, and drink water freely.
• discontinue any anti-Parkinson’s treatment at least 12 hours before a neurological examination.
• drink plenty of water and remain well hydrated before starting the examination to allow frequent urination during the first hour after the study.

After administration of Fluorodopa (F) Curium Italy, you must:

• avoid close contact with young children for the 12 hours following injection.
• urinate frequently to eliminate the product from your body.
  Regulations regarding the use, handling, and disposal of radiopharmaceuticals are very strict. Fluorodopa (F) Curium Italy will only be used in a hospital setting. The product will be handled and administered to you only by trained and qualified personnel to ensure safe use. These individuals will take special care in the safe handling of the product and will keep you informed about the procedures.

Driving and use of machines
It is considered unlikely that Fluorodopa (F) Curium Italy will impair your ability to drive or operate machinery.
Fluorodopa (F) Curium Italy contains less than 1 mmol of sodium (23 mg) per injection and is therefore essentially “sodium-free”.

3. How to use Fluorodopa ( F) Curium Italy

The nuclear medicine specialist supervising the procedure will decide the amount of Fluorodopa ( F)
Curium Italy to be used in your case. This will be the minimum quantity necessary to obtain the desired
information.
The recommended administered activity for an adult is usually 4 MBq/kg of body weight. The radioactive dose
may be halved in neurological indications where whole-body imaging is not planned.
Use in children and adolescents
In the case of the paediatric population, the administered amount will be adjusted according to the child's
body mass.
Administration of Fluorodopa ( F) Curium Italy and examination procedure
Fluorodopa ( F) Curium Italy will be administered slowly over a period of approximately one minute into a
vein in your arm.
A single injection is sufficient to provide the physician with the necessary information.
Duration of the examination
Your doctor will inform you about the usual duration of the examination.
If you are given more Fluorodopa ( F) Curium Italy than you should have received
An overdose is unlikely, as you will receive only one dose of Fluorodopa ( F) Curium Italy under the strict
supervision of the specialist performing your examination. However, in the event of an overdose, you will receive
appropriate treatment. In particular, the specialist performing your examination may advise you to drink plenty of
fluids to help eliminate Fluorodopa ( F) Curium Italy from your body. This medicinal product is mainly excreted
via the kidneys into the urine.
If you have any doubts about the use of Fluorodopa ( F) Curium Italy, consult your doctor or the nuclear medicine
specialist who will perform your examination.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicinal product can cause adverse reactions, although not everybody experiences them.
The following have been reported: burning sensation, pain at the application site, pain, and warmth at the application site.
Pain at the injection site has been reported to disappear spontaneously within a few minutes.
One case of "carcinoid crisis" has been reported: nausea, vomiting, diarrhoea, rapid heart rate (tachycardia), hypotension, facial and chest flushing.
This radiopharmaceutical delivers low amounts of ionising radiation, with a very low risk of cancer and hereditary abnormalities.
Your doctor will have considered that the clinical benefit you will derive from the examination with the radiopharmaceutical outweighs the risk due to radiation exposure.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact the nuclear medicine physician. You may also report adverse reactions directly via the
Website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, you can help provide more information on the safety of this medicinal product.

5. Contents of the pack and other information

What Fluorodopa (F) Curium Italy contains

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

Description of the appearance of Fluorodopa (F) Curium Italy and contents of the pack
You should not handle or manipulate the packaging or vial; the following information is provided for your awareness only.
The radioactivity of a vial ranges between 90 MBq and 900 MBq at the date and time of calibration.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
In Italy:
Curium Italy S.r.l.
Via Nicola Piccinni, 2
I-20131 Milan

Manufacturers
CIS bio international
F-33600 Pessac
CIS bio international
F-35042 Rennes Cedex
CIS bio international
F-95200 Sarcelles
CIS bio international
F-54500 Vandœuvre-lès-Nancy
Laboratoires Cyclopharma
F-13013 Marseille
Curium Italy S.R.L.
I-20900 Monza
Curium Pharma Spain, S.A.
E-28040 Madrid
Curium Pharma Spain, S.A.
E-41092 Sevilla

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
DOPACIS in France, Luxembourg, Malta, the Netherlands, Portugal, Slovenia and Spain.
Fluorodopa (F) CIS bio international in Belgium.
Fluorodopa (F) Curium Italy in Italy.

The following information is intended exclusively for healthcare professionals.
The complete Summary of Product Characteristics for Fluorodopa (F) Curium Italy is provided as a separate document within the product packaging, intended to provide physicians and healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Refer to the SmPC.