Dopaview 222 MBq/ml solution for injection
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
DOPAVIEW 222 MBq/ml solution for injection
Fluorodopa (18F)
Read all of this leaflet carefully before you are given this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any further questions, consult the nuclear medicine physician supervising 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.
Contents of this leaflet
- What DOPAVIEW is and what it is used for
- What you need to know before receiving DOPAVIEW
- How DOPAVIEW is given
- Possible side effects
- How to store DOPAVIEW
- Contents of the pack and other 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 prior to such scans.
The active substance in DOPAVIEW is fluorodopa (18F). It is used to obtain 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.
2. What you need to know before using DOPAVIEW
Do not use DOPAVIEW
- if you are allergic (hypersensitive) to fluorodopa (18F) or to any of the other components of this medicine (see section 6),
- if you are pregnant.
Warnings and precautions
Talk to your nuclear medicine physician before receiving DOPAVIEW in the following cases:
- if you have kidney problems
Inform your nuclear medicine physician in the following cases:
- if you are pregnant or think you may be pregnant,
- if you are breastfeeding
Before administration of DOPAVIEW you must:
- drink plenty of water before starting the procedure, and urinate as frequently as possible during the first 4 hours after the procedure
- remain fasting for at least 4 hours.
Children and adolescents
Inform your nuclear medicine physician if you are under 18 years of age.
Use of DOPAVIEW with other medicines
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 they may interfere with image interpretation, especially if you are receiving treatment for Parkinson’s disease such as carbidopa, neuroleptics such as haloperidol, antidepressants of the MAOI or COMT class, or reserpine.
If you have any doubts, ask your physician or nuclear medicine physician.
Use of DOPAVIEW with food and drink
You must remain fasting for at least four hours before administration of DOPAVIEW.
To obtain the best image quality and to reduce radiation exposure to the bladder, it is recommended to drink abundantly 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 physician before using this medicine.
If in doubt, it is important to consult the nuclear medicine physician supervising 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 any milk expressed during that period. Ask your nuclear medicine physician when you can resume breastfeeding.
Driving and use of machines
The effect on the ability to drive and use machines has not been studied.
DOPAVIEW is considered unlikely to affect your 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). This should be taken into account if you are on a low-sodium diet.
3. How to use DOPAVIEW
There are strict regulations regarding 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 who are skilled in its safe use. These individuals will take particular care in the safe handling of this product and will inform you about their actions.
The nuclear medicine physician supervising the procedure will determine the amount of DOPAVIEW to be used in your case. This will be the minimum quantity necessary to obtain the required information.
Adults
The generally recommended dose for administration in adults ranges between 1 and 4 MBq/kg (depending on the indication, type of camera used, and 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 medicinal product in children and adolescents under 18 years of age.
Administration of DOPAVIEW and performance of the procedure
DOPAVIEW is administered by intravenous route.
Your nuclear medicine physician will explain to you how the procedure with this medicinal product will be performed.
Duration of the procedure
Your nuclear medicine physician will inform you about the usual duration of the procedure.
After receiving DOPAVIEW, you should:
- avoid direct contact with young children and pregnant women during the 12 hours following injection
- urinate frequently to eliminate the product from your body.
The nuclear medicine physician will inform you if any special precautions are necessary after receiving this medicinal product. Consult your nuclear medicine physician if you have any doubts.
If you have been given more DOPAVIEW than you should
An overdose is unlikely, as you will receive a single dose of DOPAVIEW precisely controlled by the nuclear medicine physician supervising the procedure. However, in the event of an overdose, appropriate treatment will be administered. Elimination of the radioactive compounds should be increased as much as possible. You should drink as much fluid as possible and empty your bladder frequently.
If you have any further questions about the use of DOPAVIEW, ask the nuclear medicine physician supervising the procedure.
4. Possible adverse effects
Like all medicines, DOPAVIEW may cause adverse effects, although not everyone will experience them.
To date, no serious adverse effects have been observed.
In rare cases, pain during injection has been reported, which resolved within minutes without specific intervention.
One case of 'carcinoid crisis' has been reported: nausea, vomiting, diarrhoea, elevated heart rate (tachycardia), hypotension, and redness of the face and chest.
Administration of this radiopharmaceutical involves exposure to a small amount of ionizing radiation, carrying a very low risk of developing cancer and hereditary defects.
Adverse effects of unknown frequency:
- Burning sensation
- Pain at the injection site
Reporting of adverse effects
If you experience any type of adverse effect, consult your nuclear medicine physician, even if the effects are not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Conservation of DOPAVIEW
Do not use DOPAVIEW after the expiry date stated on the container label following EXP.
You will not be required to store this medicinal product. This medicinal product is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
6. Contents of the pack and other information
Composition of DOPAVIEW
- 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 at 9 mg/ml, water for injectable preparations, EDTA, sodium acetate, acetic acid, sodium citrate, citric acid and ascorbic acid.
Appearance of the product and contents of the pack
You will not have to purchase this medicine or handle the container or vial; the information below is provided for informational purposes only.
DOPAVIEW is a clear, colourless or slightly yellowish liquid.
The total activity in 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)
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 medicinal product is authorised 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 the most recent review of this leaflet: December 2020
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.es.
This information is intended for healthcare professionals only:
The complete summary of product characteristics for DOPAVIEW is included as a separate document within the product packaging, providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Please consult the summary of product characteristics (the summary of product characteristics must be included in the package).