FLUOROCOLINA (18F) CIS BIO INTERNATIONAL 225 MBq/mL INJECTABLE SOLUTION
How to use FLUOROCOLINA (18F) CIS BIO INTERNATIONAL 225 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.
Show originalContents of the leaflet
- Introduction
- What is Fluorocoline (18F) CIS bio international and what is it used for
- What you need to know before you are given Fluorocoline (18F) CIS bio international
- How to use Fluorocoline (18F) CIS bio international
- Possible Side Effects
- Storage of Fluorocoline (18F) CIS bio international
- Package Contents and Further Information
Introduction
Package Leaflet: Information for the Patient
Fluorocoline (18F) CIS bio international 225 MBq/ml Solution for Injection
Fluorocoline Chloride (18F)
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 further questions, ask your doctor or the nuclear medicine doctor who will be supervising the procedure.
- If you experience any side effects, talk to your doctor or the nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.
Contents of the Package Leaflet
- What is Fluorocoline (18F) CIS bio international and what is it used for
- What you need to know before you are given Fluorocoline (18F) CIS bio international
- How to use Fluorocoline (18F) CIS bio international
- Possible side effects
- Storage of Fluorocoline (18F) CIS bio international
- Package Contents and Further Information
1. What is Fluorocoline (18F) CIS bio international and what is it used for
This medicine is a radiopharmaceutical for diagnostic use only. Fluorocoline (18F) CIS bio international contains the active substance fluorocoline (18F).
Fluorocoline (18F) CIS bio international is used in positron emission tomography (PET) procedures in adult men with prostate diseases.
The active substance in Fluorocoline (18F) CIS bio international allows for the acquisition of images of certain parts of your body.
The purpose of this PET scan is to help decide how to treat the disease you are suffering from or are suspected to be suffering from.
Administration of fluorocoline (18F) involves receiving a small amount of radioactivity. Your doctor and the nuclear medicine doctor have considered that the clinical benefit you will gain from this procedure with the radiopharmaceutical outweighs the risk due to radiation.
2. What you need to know before you are given Fluorocoline (18F) CIS bio international
Do not use Fluorocoline (18F) CIS bio international
- if you are allergic to fluorocoline (18F) or any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant.
Warnings and Precautions
Before administration of Fluorocoline (18F) CIS bio international, you must:
- fast for at least 4 hours.
- drink plenty of water before starting the procedure so that you are well hydrated and urinate as frequently as possible during the first few hours after the procedure.
Children and Adolescents
Fluorocoline (18F) CIS bio international is not indicated in the pediatric population.
Use of Fluorocoline (18F) CIS bio international with other medicines
Tell your nuclear medicine doctor if you are taking, have recently taken, or might take any other medicines, as some medicines may interfere with the interpretation of the images by your doctor, in particular:
- if you are being treated with anti-androgen therapy.
- if you have been treated with chemotherapy.
- if you have been treated with medicines that increase blood cell production.
- if you have been treated with colchicine (e.g., to treat gout).
If you have any doubts, consult your nuclear medicine doctor who will be performing the PET procedure.
Use of Fluorocoline (18F) CIS bio international with food and drinks
You must fast for at least 4 hours before administration of Fluorocoline (18F) CIS bio international, as some foods may decrease the quality of the images.
Pregnancy and Breastfeeding
Fluorocoline (18F) CIS bio international is not indicated in women.
Driving and Using Machines
It is unlikely that Fluorocoline (18F) CIS bio international will affect your ability to drive or use machines.
Fluorocoline (18F) CIS bio international contains sodium
This medicine contains sodium (3.54 mg/ml). Depending on the volume injected, the limit of 1 mmol (23 mg) of sodium per administered dose may be exceeded, which should be taken into account in patients on low-sodium diets.
3. How to use Fluorocoline (18F) CIS bio international
There are strict rules on the use, handling, and disposal of radiopharmaceuticals.
Fluorocoline (18F) CIS bio international will only be used in special controlled areas. This medicine 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 Fluorocoline (18F) CIS bio international to be used in your case, which will be the minimum amount necessary to obtain the desired information.
Posology
The amount to be administered is determined based on your body weight and depends on the type of camera used to obtain images of your body.
The recommended activity ranges from 100 to 400 MBq for a 70 kg adult. MBq means megabecquerel, which is the unit used to express radioactivity.
Administration of Fluorocoline (18F) CIS bio international and Performance of the Procedure
Fluorocoline (18F) CIS bio international is administered intravenously.
A single injection is sufficient to perform the procedure your doctor needs.
After the injection, you will be offered a drink and asked to urinate immediately before starting the procedure.
Duration of the Procedure
Your nuclear medicine doctor will inform you about the usual duration of the procedure.
After Administration of Fluorocoline (18F) CIS bio international, 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 indicate if you need to take any special precautions after receiving this medicine.
Consult your nuclear medicine doctor if you have any doubts.
If you are given more Fluorocoline (18F) CIS bio international than you should
Overdose is unlikely because you will receive a single, precisely controlled dose of Fluorocoline (18F) CIS bio international by the nuclear medicine doctor supervising the procedure.
However, in case of overdose, you will receive appropriate treatment. In particular, the nuclear medicine doctor in charge of the procedure will recommend that you drink plenty of water to facilitate the elimination of radioactivity from the body.
If you have any further questions about the use of Fluorocoline (18F) CIS bio international, ask your nuclear medicine doctor who supervises the procedure.
4. Possible Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
To date, no side effects have been observed.
Administration of this radiopharmaceutical involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and genetic disorders.
Reporting of Side Effects
If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency's website www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Fluorocoline (18F) CIS bio international
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 Further Information
Composition of Fluorocoline (18F) CIS bio international
- The active substance is fluorocoline (18F). Each milliliter of solution for injection contains 225 MBq at the date and time of calibration.
- The other ingredients are sodium chloride and water for injections.
Appearance of the Product and Package Contents
You will not need to store or handle this medicine. The following information is for your information only.
Fluorocoline (18F) CIS bio international is a clear, colorless liquid.
The activity per vial ranges from 112 MBq to 3375 MBq at the date and time of calibration.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
CIS bio international
RN 306 SACLAY
BP 32
F-91192 GIF-SUR-YVETTE CEDEX
Manufacturer
CURIUM PET FRANCE
PARC SCIENTIFIQUE ET TECHNIQUE G. BESSE
180, ALLEE VON NEUMANN
30035 NÎMES CEDEX 1
FRANCE
CURIUM PET FRANCE
HÔPITAL XAVIER ARNOZAN
AVENUE DU HAUT LEVÊQUE
33600 PESSAC
FRANCE
CURIUM PET FRANCE
CENTRE EUGENE MARQUIS
AVENUE DE LA BATAILLE FLANDRES DUNKERQUE
35042 RENNES CEDEX
FRANCE
CURIUM PET FRANCE
10 AVENUE CHARLES PEGUY
95200 SARCELLES
FRANCE
CURIUM PET FRANCE
CHU DE BRABOIS
AVENUE DE BOURGOGNE
54500 VANDOEUVRE-LES-NANCY
FRANCE
CURIUM Italy S.R.L.
VIA PERGOLESI 33,
20900 MONZA
ITALY
CURIUM ITALY S.R.L.
VIALE OXFORD 81,
00133 ROME
ITALY
CURIUM ITALY S.R.L.
PIAZZALE SANTA MARIA DELLA MISERICORDIA 15,
33100 UDINE
ITALY
OFFICINA FARMACEUTICA
ISTITUTO DI FISIOLOGIA CLINICA DEL CNR
VIA MORUZZI, 1
56124 PISA
ITALY
SPARKLE S.R.L.
CONTRADA CALO’
73042 CASARANO (LE)
ITALY
CURIUM PHARMA SPAIN S.A.
PARQUE TECNOLÓGICO CARTUJA'93
AVDA. THOMAS ALVA EDISON 7
41092 SEVILLA
SPAIN
CURIUM PHARMA SPAIN S.A.
POL. IND. CONPISA, C/ VEGUILLAS 2- NAVE 16
28864 AJALVIR (MADRID)
SPAIN
B.V. CYCLOTRON VU
DE BOELELAAN 1081
1081 HV AMSTERDAM
THE NETHERLANDS
CYCLOTRON VU
VAN DER BOECHORSTSTRAAT 6A
1081 BT AMSTERDAM
THE NETHERLANDS
You can request more information about this medicine by contacting the local representative of the marketing authorization holder:
Curium Pharma Spain, S.A.
Avda. Dr. Severo Ochoa, 29
28100-Alcobendas
Phone: 91 4841989
This medicine is authorized in the Member States of the European Economic Area under the following names:
Belgium, France, Luxembourg, Netherlands, and Malta: Fluorocholine (18F) CIS bio international
Portugal and Spain: Fluorocoline (18F) CIS bio international
Slovenia: [18F] Fluoroholin CIS bio international
Italy: Fluorocoline (18F) Curium Italy
Date of Last Revision of this Leaflet: January 2020
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/.
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This information is intended for healthcare professionals only:
The full summary of product characteristics of Fluorocoline (18F) CIS bio international is included as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Please consult the summary of product characteristics of the medicine.
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- 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.
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