DOPAVIEW 222 MBq/mL Injectable Solution
How to use DOPAVIEW 222 MBq/mL INJECTABLE SOLUTION
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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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
- What DOPAVIEW is and what it is used for
- What you need to know before using DOPAVIEW
- How to use DOPAVIEW
- Possible side effects
- Storage of DOPAVIEW
- 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).
-
- Country of registration
- Dosage formINJECTABLE, 222 MBq/ml
- ATC codeV09IX05
- Active substance
- Prescription requiredYes
- Manufacturer
- CompositionCITRATO DE SODIO (E-331) (23.81 mg mg), ACETATO SODICO (0.136 mg mg), CLORURO DE SODIO (9 mg mg)
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to DOPAVIEW 222 MBq/mL INJECTABLE SOLUTIONDosage form: INJECTABLE, 90 MBq/ml at the time of calibrationActive substance: fluorodopa (18F)Manufacturer: Cis Bio InternationalPrescription requiredDosage form: INJECTABLE, 74 MBq iobenguane (123I)Active substance: iobenguane (123I)Manufacturer: Ge Healthcare Bio-Sciences, S.A.U.Prescription requiredDosage form: INJECTABLE, 1600 MBq/mlActive substance: fluciclovine (18F)Manufacturer: Blue Earth Diagnostics Ireland LimitedPrescription required
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Frequently Asked Questions
Is a prescription required for DOPAVIEW 222 MBq/mL INJECTABLE SOLUTION?
DOPAVIEW 222 MBq/mL INJECTABLE SOLUTION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in DOPAVIEW 222 MBq/mL INJECTABLE SOLUTION?
The active ingredient in DOPAVIEW 222 MBq/mL INJECTABLE SOLUTION is fluorodopa (18F). This information helps identify medicines with the same composition but different brand names.
Who manufactures DOPAVIEW 222 MBq/mL INJECTABLE SOLUTION?
DOPAVIEW 222 MBq/mL INJECTABLE SOLUTION is manufactured by Advanced Accelerator Applications Molecular Imaging France. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of DOPAVIEW 222 MBq/mL INJECTABLE SOLUTION online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether DOPAVIEW 222 MBq/mL INJECTABLE SOLUTION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
How to buy DOPAVIEW 222 MBq/mL INJECTABLE SOLUTION in Spain?
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy DOPAVIEW 222 MBq/mL INJECTABLE SOLUTION in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
What are the alternatives to DOPAVIEW 222 MBq/mL INJECTABLE SOLUTION?
Other medicines with the same active substance (fluorodopa (18F)) include DOPACIS 90 MBq/ml INJECTABLE SOLUTION, ADREVIEW 74 MBq/ml INJECTABLE SOLUTION, AXUMIN 1600 MBq/ML INJECTABLE SOLUTION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
