FLUORODOPA 0,3 GBQ/ML Концентрат для инъекционного раствора

Содержание инструкции

1. Fluorodopa ( F) Curium Austria 0.3 GBq/mL, injectable solution
   1. What is Fluorodopa ( F) Curium Austria and what is it 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

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

6-fluoro-( F)-L-dihydroxyphenylalanine (or 6-fluoro-( F)-L-dopa)

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 doctor who will supervise the procedure.
• If any side effects occur, including those not listed in this leaflet, tell your nuclear medicine doctor .

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 given to you
• 3. How Fluorodopa ( F) Curium Austria will be given to you
• 4. Possible side effects
• 5. How to store Fluorodopa ( F) Curium Austria
• 6. Contents of the pack and other information

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

This medicine is a radiopharmaceutical for diagnostic use only.
Fluorodopa ( F) Curium Austria is used for diagnosis in Positron Emission Tomography (PET) examination and is administered before such examination.
The radioactive substance present in Fluorodopa ( F) Curium Austria (to show dopamine metabolism) is identified by the PET and shown in an image.
Positron Emission Tomography is an imaging technology used in nuclear medicine that produces images of cross-sections of living organisms. It works with small amounts of radioactive drug to produce quantitative and precise images of specific metabolic processes of the body. This examination is performed to help decide how to treat the illness you suffer from or are suspected of suffering from.

2. What you need to know before Fluorodopa (F) Curium Austria is administered to you

Fluorodopa (F) Curium Austriawill not be administered to you

• 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 before administration (see section 6).
• If you are pregnant.

Warnings and precautions
Pay particular attention with Fluorodopa (F) Curium Austria and consult your nuclear medicine physician
before Fluorodopa (F) Curium Austria is administered to you in the following cases:

• If you are pregnant or suspect you may 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 the administration of Fluorodopa (F) Curium Austria you must:

• Drink plenty of water before the start of the examination so that you urinate as often as possible during the first few hours after the study.
• Fast for at least 4 hours.

Children and adolescents
Consult your 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 these may interfere with the interpretation of the images.

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

Fluorodopa (F) Curium Austria with food and drink
It is recommended to fast for at least 4 hours before the administration of Fluorodopa (F)
Curium Austria.
To obtain good quality images and reduce radiation exposure to the bladder, it is
recommended to drink plenty of fluids before and after the examination (water and sugar-free tea are
allowed) and to empty your bladder frequently.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your nuclear medicine physician for advice before this medicine is administered to you.
You must inform your nuclear medicine physician before the administration of Fluorodopa (F)
Curium Austria if there is a possibility that you may be pregnant, if you have missed a period or if you are
breastfeeding.
If you have any doubts, it is important that you consult the nuclear medicine physician supervising the procedure.

If you are pregnant
Fluorodopa (F) Curium Austria should not be used if you are pregnant.

If you are breastfeeding
If you are breastfeeding, breast milk can be expressed before the injection and
stored for later use. Breastfeeding must be interrupted
for at least 12 hours. The milk produced during this period must be discarded.
Ask your nuclear medicine physician when you can resume breastfeeding.

Driving and operating machinery
It is unlikely that Fluorodopa (F) Curium Austria will affect your ability to drive vehicles or
operate machinery.

Fluorodopa (F) Curium Austria contains sodium and ethanol
This medicine may contain more than 1 mmol of sodium (23 mg). You should take this into
account if you are on a low-sodium diet.
This medicine 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 laws regulating the use, handling and disposal of radiopharmaceuticals.
Fluorodopa ( F) Curium Austria will only be used in hospital. This product will be handled and
administered only by trained and qualified personnel to use it respecting safety criteria.
These people will take particular care to use this product safely and will keep you
informed of their actions.
The nuclear medicine physician supervising the procedure will decide the amount of Fluorodopa ( F)
Curium Austria to use in your case. It will be the smallest amount necessary to obtain the
desired information.

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

Use in children and adolescents
There are limited clinical data regarding the use of the drug in children and adolescents under the age of
18 years.
In the case of use in children and adolescents, the amount to be administered will be adjusted to the
child's weight.

Administration of Fluorodopa (F) Curium Austria and carrying out the procedure
Fluorodopa ( F) Curium Austria is administered by slow intravenous injection lasting approximately
one minute.
One injection is sufficient to perform the examination necessary for the doctor.
After the injection, you will be given something to drink and asked 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 the administration of Fluorodopa (F) Curium Austria, you must:

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

The nuclear medicine physician will inform you if any special precautions need to be taken after
receiving the drug. Contact your nuclear medicine physician for any further questions.

If you have been given more Fluorodopa (F) Curium Austria than you should
An overdose is unlikely as you will only receive a single dose of Fluorodopa ( F) Curium
Austria carefully controlled by the nuclear medicine physician supervising the procedure.
However, in case of overdose, you will receive appropriate treatment. The elimination of radioactive
components must be increased as much as possible. You should drink as much water as possible and empty
your bladder frequently. Diuretics may be necessary.
If you have any further questions about the use of Fluorodopa ( F) Curium Austria, please contact 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
will experience them.
No serious side effects have been observed to date.
In rare cases, 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, which carries a very low risk
of cancer and hereditary abnormalities.
The nuclear medicine physician has considered that the clinical benefit obtained from the procedure
with the radiopharmaceutical outweighs the risk due to radiation.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please contact
your nuclear medicine physician. You can also report side effects directly through the
national reporting system ( https://www.aifa.gov.it/en/content/segnalazioni-reazioni-avverse ).
By reporting side effects, you can help provide more information on the safety
of this medicine.

5. How to store Fluorodopa ( F) Curium Austria

You must not store this medicine. This medicine will be stored under the responsibility of the specialist in appropriate facilities. The storage of radiopharmaceuticals will occur in accordance with national regulations on radioactive materials.
The following information is intended exclusively for the specialist.
Fluorodopa ( F) Curium Austria must not be used after the expiration date reported on the label.

6. Contents of the pack and other information

What Fluorodopa (F) Curium Austria contains

• The active substance is 6-fluoro-( F)-L-dihydroxyphenylalanine (or 6-fluoro-( F)-L-dopa). 1 mL of the pharmaceutical form 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 packFluorodopa ( F) Curium Austria is a clear and colourless or slightly yellowish solution. The total activity of the vial at the date and time of calibration is between 0.15 and 6.0 GBq.

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]

Manufacturer
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 denominations:
France IASOdopa 0.3 GBq/mL, injectable solution.
Austria IASOdopa 0.3 GBq/mL - Injektionslösung
Germany IASOdopa 0.3 GBq/ml, Injektionslösung
Italy Fluorodopa ( F) Curium Austria 0.3 GBq/mL, injectable solution

This leaflet was last approved on.
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 doctors or healthcare professionals:
The complete summary of product characteristics (SmPC) of Fluorodopa ( F) Curium
Austria is attached to the pack as a separate document, with the aim of providing healthcare professionals with further scientific and practical information on the administration and use of this
radiopharmaceutical.
Reference is therefore made to the SmPC (which must be included in the box).