Patient Information Leaflet

DOPAVIEW 222MBq/ml injectable solution

Fluorodopa (18F)

Read this leaflet carefully before you receive this medicine, as it contains important information for you.

- Keep this leaflet, as you may need to read it again.

- If you have any other questions, consult the nuclear medicine physician overseeing the procedure.

- If you experience any side effects, consult your nuclear medicine physician, even if they are not listed in this leaflet. See section 4.

1. What isDOPAVIEWand how is it used

2. What you need to know before starting to useDOPAVIEW

3. How to useDOPAVIEW

4. Possible side effects

5. Storage ofDOPAVIEW

6. Contents of the package and additional information

This medication is a radiopharmaceutical for diagnostic use only.

DOPAVIEW is used for diagnostic purposes in positron emission tomography (PET) scans and is administered before such an examination.

The active principle contained in DOPAVIEW is fluorodopa (18F).It is used for the acquisition of diagnostic images of certain parts of your body.

After injecting a small amount of DOPAVIEW, medical images obtained with a special camera will allow your doctor to determine the location or progression of your disease.

No use DOPAVIEW

- if you are allergic (hypersensitive) to fluorodopa (18F) or to any of the other components of this medication (see section 6),

- if you are pregnant.

Warnings and precautions

Speak with your nuclear medicine doctor before they administer DOPAVIEW in the following cases:

• if you have kidney problems

Inform your nuclear medicine doctor in the following cases:

- if you are pregnant or if you think you may be pregnant,

- if you are breastfeeding

Before DOPAVIEW administration, you must:

- drink a lot of water before starting the procedure to urinate as many times as possible during the first 4 hours after the procedure

- remain fasting for at least 4 hours.

Children and adolescents

Inform your nuclear medicine doctor if you are under 18 years old.

Use of DOPAVIEW with other medications

Inform your nuclear medicine doctor who will supervise the procedure if you are taking or have recently taken other medications, including those purchased without a prescription, as they may interfere with image interpretation, especially if you are taking Parkinson's disease treatments such as carbidopa, neuroleptics such as haloperidol, class IMAO and COMT antidepressants, or reserpine.

If you have any doubts, ask your doctor or nuclear medicine doctor.

Use of DOPAVIEW with food and drinks

You must be fasting for at least 4 hours before DOPAVIEW administration.

To obtain the best image quality and to reduce bladder radiation exposure, it is recommended to drink in abundance before and after the examination.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your nuclear medicine doctor before using this medication.

In case of doubt, it is essential to consult the nuclear medicine doctor who will supervise the procedure.

If you are pregnant

The use of Dopaview is contraindicated in pregnant women.

If you are breastfeeding

You must stop breastfeeding your child for 12 hours after the injection and discard the milk expressed during that period. Ask your nuclear medicine doctor when you can resume breastfeeding.

Driving and using machines

The effect on the ability to drive and use machines has not been studied.

It is considered unlikely that Dopaview will affect the ability to drive or use machines.

DOPAVIEW contains sodium

Once prepared immediately before administration, this product may contain more than 1mmol of sodium (23mg). You should take this into account if you follow a low-sodium diet.

There are strict guidelines for the use, handling, and disposal of radiopharmaceuticals.

DOPAVIEW will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel to use it safely. Those individuals will take special care in the safe use of this product and will inform you of their actions.

The nuclear medicine physician overseeing the procedure will decide on the amount of DOPAVIEW to be used in your case. This will be the minimum amount necessary to obtain the desired information.

Adults

The generally recommended dose for administering to an adult ranges from 1 to 4MBq/kg (depending on the indication, the type of camera used, and the image acquisition mode).

The megabecquerel (MBq) is the unit used to express radioactivity.

Use in children and adolescents

There are few available clinical data on the use of this medication in children and adolescents under 18 years old.

Administration of DOPAVIEW and procedure performance

DOPAVIEW is administered intravenously.

Your nuclear medicine physician will explain how the procedure with this medication will be performed.

Procedure duration

Your nuclear medicine physician will inform you of the usual duration of the procedure.

After DOPAVIEW administration, you must:

- avoid direct contact with small children and pregnant women in the 12 hours following the injection

- urinate frequently to eliminate the product from your body.

Your nuclear medicine physician will inform you if you need to take any special precautions after receiving this medication. Consult with your nuclear medicine physician if you have any doubts.

If you have been administered more DOPAVIEW than you should

It is unlikely to have an overdose because you will receive a single, precisely controlled dose of DOPAVIEW from the nuclear medicine physician overseeing the procedure. However, in the event of an overdose, you will receive the necessary treatment. The elimination of radioactive compounds should be increased as much as possible. You should drink as much as possible and empty your bladder frequently.

If you have any other questions about the use of DOPAVIEW, ask the nuclear medicine physician overseeing the procedure.

Like all medications, DOPAVIEW may produce adverse effects, although not all people will experience them.

To date, no serious adverse effects have been observed.

In rare cases, pain during injection was reported, which resolved in minutes without taking specific measures.

A case of ‘carcinoid crisis’ was reported: nausea, vomiting, diarrhea, elevated heart rate (tachycardia), hypotension, facial and chest flushing.

The administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary defects.

Adverse effects of unknown frequency:

Burning sensation

Pain at the injection site

Reporting Adverse Effects

If you experience any type of adverse effect, consult your nuclear medicine doctor, even if it is an adverse effect not listed in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance for Human Use Medications: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Do not use DOPAVIEW after the expiration date that appears on the label of the packaging after CAD.

You will not need to store this medication. This medication is stored under the responsibility of the specialist in appropriate facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

Composition of DOPAVIEW

- The active principle is fluorodopa (18F): 1ml of solution contains 222MBq of fluorodopa (18F) at the time and date of calibration

- The other components are: sodium chloride 9mg/ml, water for injection, EDTA, sodium acetate, acetic acid, sodium citrate, citric acid, and ascorbic acid.

Aspect of the product and contents of the packaging

No need to purchase this medication or manipulate the packaging or vial, the information included below is solely for informational purposes.

DOPAVIEW is a transparent and colorless or slightly yellowish liquid.

The total activity of the vial at the time and date of calibration ranges from 111MBq to 2220MBq.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Advanced Accelerator Applications Molecular Imaging France SAS

20 rue Diesel

01630 Saint-Genis-Pouilly

France

Responsible for manufacturing

Advanced Accelerator Applications Molecular Imaging France SAS

27boulevard Jean Moulin

13005Marseille

France

Advanced Accelerator Applications GermanyGHmbH

Saime-Genc-Ring 18

53121 Bonn

Germany

Advanced Accelerator Applications (Portugal), Unipessoal, LDA

Rua Fonte das Sete Bicas, 170, Matosinhos

4460-283Matosinhos

Portugal

Advanced Accelerator ApplicationsMolecular Imaging France SAS

Technopole de l’Aube

14 Rue Gustave Eiffel

10430 Rosières Près Troyes

France

Advanced Accelerator ApplicationsMolecular Imaging France SAS

20rue Diesel

01630Saint 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 ApplicationsMolecular Imaging France SAS

126 Rocade Sud,

62660 Beuvry

France

ITEL TELECOMUNICAZIONI S.R.L.

Via Antonio Labriola (Zona Industriale)

Ruvo di Puglia (BA) - SNC 70037

Italy

Advanced Accelerator Applications Molecular Imaging Iberica, S.L.U.

Hospital Clínico Universitario Virgen de la Arrixaca

Carretera Madrid-Cartagena, s/n,

El Palmar, 30120 Murcia

Spain

Local Representative

Advanced Accelerator Applications Molecular Imaging Iberica, S.L.U.

C/ Josep Anselm Clavé, 100

08950 Esplugues de Llobregat (Barcelona)

Spain

This medication is authorized in the Member States of the European Economic Area with 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:DOPAVIEW 222 MBq/mL solution for injection

Last review date of this leaflet:December 2020

Other sources of information

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

-----------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:

The complete technical file of DOPAVIEW is included as a separate document in the product packaging, with the aim of providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the technical file (the technical file must be included in the box).