Padoview

Package leaflet: Information for the patient

PADOVIEW 222 MBq/mL solution for injection

Fluorodopa (18F)
Please read all of 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 questions, ask the nuclear medicine specialist who will supervise the procedure.
• If you experience any side effects, including those not listed in this leaflet, inform the nuclear medicine specialist. See section 4.

Contents of this leaflet

1. What PADOVIEW is and what it is used for
2. What you need to know before being given PADOVIEW
3. How PADOVIEW is given
4. Possible side effects
5. How to store PADOVIEW
6. Contents of the pack and other information

1. What PADOVIEW is and what it is used for

This medicinal product is a radiopharmaceutical for diagnostic use only.
PADOVIEW is used for diagnosis in positron emission tomography (PET) imaging and is
administered prior to such examination.
The radioactive substance contained in PADOVIEW is fluorodopa (18F). It is used to produce
diagnostic images of specific parts of the body.
After injecting a small amount of PADOVIEW, medical images obtained using a special camera
will allow the doctor to locate the disease or monitor its progression.

2. What you need to know before using PADOVIEW

Do not take PADOVIEW

• if you are allergic (hypersensitive) to fluorodopa (18F) or to any of the other ingredients of PADOVIEW (see section 6),
• if you are pregnant.

Warnings and precautions
Inform your nuclear medicine specialist before being administered PADOVIEW
in the following cases:

• if you have kidney problems. Inform your nuclear medicine specialist in the following cases:
• if you are pregnant or suspect you might be pregnant,
• if you are breastfeeding.

Before administration of PADOVIEW you must:

• drink plenty of water before the examination begins, so that you urinate as frequently as possible during the first 4 hours after the examination,
• fast for at least 4 hours.

Children and adolescents
Please consult the nuclear medicine specialist if you are under 18 years of age.
Other medicines and PADOVIEW
Inform the nuclear medicine specialist supervising the procedure if you are taking or have recently taken any other medicines, including those obtained without a prescription, as they may interfere with the interpretation of images. This is particularly important if you are taking treatments for Parkinson's disease such as carbidopa, neuroleptics such as haloperidol, MAOI and COMT inhibitors, or reserpine.
If you have any doubts, consult your doctor or nuclear medicine specialist.
PADOVIEW with food and drinks
Fasting for at least 4 hours before administration of PADOVIEW is recommended.
However, 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.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, please consult your nuclear medicine specialist before administration of this medicinal product.
If you have any doubts, it is important to consult the nuclear medicine specialist who will supervise the procedure.
If you are pregnant
The use of PADOVIEW is contraindicated in pregnant women.
If you are breastfeeding
Breastfeeding must be discontinued for at least 12 hours. All milk produced during this period must be discarded.
Please ask your nuclear medicine specialist when you can resume breastfeeding.
Driving and using machines
The effects on the ability to drive and use machines have not been studied.
It is considered unlikely that PADOVIEW affects the ability to drive vehicles or operate machinery.
PADOVIEW contains sodium
Once prepared immediately before administration, this medicinal product may contain more than 1 mmol of sodium (23 mg). You should take this into account if you are following a low-sodium diet.

3. How to use PADOVIEW

There are very strict laws governing the use, handling, and disposal of radiopharmaceuticals.
PADOVIEW must be used only in designated controlled areas. This product will be handled and
administered exclusively by trained and qualified personnel who are able to use it safely. Such personnel
will pay particular attention to using this medicine under safe conditions and will inform you about the procedures carried out.
The nuclear medicine specialist supervising the procedure will determine the amount of
PADOVIEW to be used in your case. This will be the smallest quantity necessary to obtain the required information.
Adults
The generally recommended administered activity for an adult ranges between 1 and 4 MBq/kg
(depending on the indication, the type of camera used for image acquisition, and the imaging protocol).
The megabecquerel (MBq) is the unit of measurement for radioactivity.
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.
Administration of PADOVIEW and conduct of the procedure
PADOVIEW is administered by intravenous injection.
The nuclear medicine specialist will explain to you how the procedure with this medicinal product will be performed.
Duration of the procedure
The nuclear medicine specialist will inform you about the expected duration of the procedure.
After receiving PADOVIEW, you must:

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

The nuclear medicine specialist will inform you if any special precautions are necessary after receiving the medicinal product. Please consult the nuclear medicine specialist for any further questions.
If you have been given more PADOVIEW than you should have received
An overdose is highly unlikely, as you will receive a single, precisely controlled dose of PADOVIEW administered under the supervision of the nuclear medicine specialist. 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 must drink plenty of fluids and empty your bladder frequently.
If you have any further questions about the use of PADOVIEW, please consult the nuclear medicine specialist supervising the procedure.

4. Possible side effects

Like all medicines, PADOVIEW can cause side effects, although not everyone experiences them.
So far, no serious adverse effects have been observed.
In rare cases, pain at the time of injection has been reported, resolving within a few minutes without any intervention.
One case of "carcinoid syndrome" has been reported: nausea, vomiting, diarrhoea, rapid heartbeat (tachycardia), hypotension, flushing of the face and chest.
The radiopharmaceutical emits low amounts of ionising radiation, which entails a very low risk of cancer and hereditary abnormalities.
Side effects of unknown frequency:
Burning sensation
Pain at the injection site

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult the specialist doctor in nuclear medicine. You may also report side effects directly via the national reporting system at the following address: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PADOVIEW

Do not use this medicinal product after the expiry date stated on the label ({GG MM
AAAA hh:mm UTC}).
You should not store this medicinal product. This medicinal product will be stored under the responsibility
of a specialist in appropriate premises. Storage of radiopharmaceuticals will comply with
national regulations concerning radioactive materials.

6. Package contents and other information

What PADOVIEW contains

• The active substance is fluorodopa (18F): 1 mL of solution contains 222 MBq of fluorodopa (18F) at the date and time of calibration.
• The other components are: sodium chloride 9 mg/mL, water for injections, EDTA, sodium acetate, acetic acid, sodium citrate, citric acid, ascorbic acid.

Description of the appearance of PADOVIEW and contents of the pack
You must not purchase this medicine nor handle the packaging or vial; the information provided below is for informational purposes only.
PADOVIEW is a clear, colourless or pale yellow liquid.
The total activity of the vial at the date and time of calibration ranges between 111 MBq and 2220 MBq.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Advanced Accelerator Applications Molecular Imaging France SAS
20 rue Diesel
01630 Saint Genis Pouilly
France

Manufacturer
Advanced Accelerator Applications Molecular Imaging France SAS
27 boulevard Jean Moulin
13005 Marseille
France
Advanced Accelerator Applications Germany GmbH
Saime-Genc-Ring 18
53121 Bonn
Germany
Advanced Accelerator Applications (Portugal), Unipessoal, LDA
Rua Fonte das Sete Bicas, 170, Matosinhos
4460-283 Matosinhos
Portugal
Advanced Accelerator Applications Molecular Imaging France SAS
Technopole de l’Aube
14 Rue Gustave Eiffel
10430 Rosières Près Troyes
France
Advanced Accelerator Applications Molecular Imaging France SAS
20 rue Diesel
01630 Saint Genis Pouilly
France
Advanced Accelerator Applications Molecular Imaging Iberica S.L.U.
c/ Josep Anselm Clavé, 100
08950 Esplugues de Llobregat (Barcelona)
Spain
Advanced Accelerator Applications Molecular Imaging France SAS
126 Rocade Sud
62660 Beuvry
France
ITEL Telecomunicazioni S.r.l
Via Antonio Labriola (Zona Industriale)
Snc - 70037 Ruvo Di Puglia (BA)
Italy

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: DOPAVIEW 222 MBq/mL Injektionslösung
Belgium: DOPAVIEW 222 MBq/ml Injektionslösung
     DOPAVIEW 222 MBq/ml solution injectable
     DOPAVIEW 222 MBq/ml oplossing voor injectie
France: DOPAVIEW
Germany: DOPAVIEW
Italy: PADOVIEW
Luxembourg: DOPAVIEW
Netherlands: DOPAVIEW
Portugal: DOPAVIEW
Spain: DOPAVIEW 222 MBq/ml solución inyectable
United Kingdom (Northern Ireland): DOPAVIEW 222 MBq/mL solution for injection

Further information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (AIFA): www.agenziafarmaco.gov.it.

The following information is intended exclusively for healthcare professionals:
The full product characteristics summary of PADOVIEW is included as a separate document within the medicine’s packaging, providing healthcare professionals with additional scientific and practical information regarding the administration and use of this radiopharmaceutical.
Please refer to the product characteristics summary (the product characteristics summary must be included in the packaging).