DOPAVIEW 222 MBq/mL INJECTABLE SOLUTION

Introduction

Patient Information Leaflet

DOPAVIEW 222MBq/ml injectable solution

Fluorodopa (18F)

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

Contents of the pack

1. What DOPAVIEW is and what it is used for
2. What you need to know before using DOPAVIEW
3. How to use DOPAVIEW
4. Possible side effects
5. Storage of DOPAVIEW
6. Package contents and additional information

1. What DOPAVIEW is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

DOPAVIEW is used for diagnosis in positron emission tomography (PET) scans and is administered before the scan.

The active ingredient 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, the medical images obtained with a special camera will allow your doctor to determine the location or progression of your disease.

2. What you need to know before using DOPAVIEW

Do not use DOPAVIEW

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

Warnings and precautions

Talk to your nuclear medicine doctor before you are given DOPAVIEW in the following cases:

• if you have kidney problems

Tell your nuclear medicine doctor in the following cases:

• if you are pregnant or think you may be pregnant,
• if you are breastfeeding

Before DOPAVIEW is administered, you must:

• drink plenty of water before starting the procedure to urinate as often as possible during the first 4 hours after the procedure
• fast for at least 4 hours.

Children and adolescents

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

Using DOPAVIEW with other medicines

Tell the nuclear medicine doctor who will supervise the procedure if you are taking or have recently taken other medicines, including those bought without a prescription, as they may interfere with the interpretation of the images, especially if you are taking treatments for Parkinson's disease, such as carbidopa, neuroleptics like haloperidol, MAOI and COMT antidepressants, or reserpine.

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

Using DOPAVIEW with food and drinks

You must fast for at least four hours before DOPAVIEW is administered.

To obtain the best image quality and to reduce radiation exposure to the bladder, it is recommended to drink plenty of water before and after the scan.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine doctor before using this medicine.

In case of doubt, it is important 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 expressed milk during this 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 1 mmol of sodium (23 mg). You should take this into account if you are on a low-sodium diet.

3. How to use DOPAVIEW

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

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

The nuclear medicine doctor who supervises the procedure will decide the amount of DOPAVIEW to be used in your case. This will be the minimum amount necessary to obtain the desired information.

Adults

The recommended amount to administer to an adult is between 1 and 4 MBq/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 is limited clinical data available on the use of this medicine in children and adolescents under 18 years old.

Administration of DOPAVIEW and performance of the procedure

DOPAVIEW is administered intravenously.

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

Duration of the procedure

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

After DOPAVIEW is administered, you must:

• avoid direct contact with small children and pregnant women for 12 hours after the injection
• urinate frequently to eliminate the product from your body.

Your nuclear medicine doctor will inform you if it is necessary to take any special precautions after receiving this medicine. Consult your nuclear medicine doctor if you have any doubts.

If you have been given more DOPAVIEW than you should

Overdose is unlikely because you will receive a single, precisely controlled dose of DOPAVIEW by the supervising nuclear medicine doctor. However, in the event of an overdose, you will receive appropriate 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 further questions about the use of DOPAVIEW, ask your nuclear medicine doctor.

4. Possible side effects

Like all medicines, DOPAVIEW can cause side effects, although not everybody gets them.

To date, no serious side effects have been observed.

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

A case of 'carcinoid crisis' was reported: nausea, vomiting, diarrhea, increased heart rate (tachycardia), hypotension, flushing of the face and chest.

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

Side effects of unknown frequency:

Burning sensation

Pain at the injection site

Reporting of side effects

If you experience any side effects, consult your nuclear medicine doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of DOPAVIEW

Do not use DOPAVIEW after the expiry date stated on the label after CAD.

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

6. Package contents and additional information

Composition of DOPAVIEW

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

Appearance and package contents

You will not need to buy this medicine or handle the packaging or vial; the information included below is for informational purposes only.

DOPAVIEW is a clear, colorless or slightly yellowish liquid.

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

Marketing authorization holder and manufacturer

Marketing authorization 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 GermanyGmbH

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 ApplicationsMolecular Imaging France SAS

Technopole de l’Aube

14 Rue Gustave Eiffel

10430 Rosières Près Troyes

France

Advanced Accelerator ApplicationsMolecular 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 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 medicine is authorized in the Member States of the European Economic Area 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: DOPAVIEW 222 MBq/mL solution for injection

Date of last revision of this leaflet:December 2020

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es.

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This information is intended only for healthcare professionals:

The complete technical data sheet 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 data sheet (the technical data sheet should be included in the box).