Fluorocholine (18F) Curium Italy
ItalyTable of Contents
PACKAGE LEAFLET
Package leaflet: information for the patient
Fluorocholine (F) Curium Italy 225 MBq/mL injectable solution
Fluorocholine (F) chloride
Please read this leaflet carefully before you are given this medicine, as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor or the nuclear medicine specialist who will supervise the entire procedure.
- If you experience any adverse reactions, including those not listed in this leaflet, contact the nuclear medicine physician. See section 4.
Contents of this leaflet
- What Fluorocholine (F) Curium Italy is and what it is used for
- What you need to know before use of Fluorocholine (F) Curium Italy
- How Fluorocholine (F) Curium Italy is used
- Possible side effects
- How to store Fluorocholine (F) Curium Italy
- Package contents and other information
1. What Fluorocholine (F) Curium Italy is and what it is used for
This medicinal product is a radiopharmaceutical for diagnostic use only. Fluorocholine (F) Curium Italy contains the active substance fluorocholine (F).
Fluorocholine (F) Curium Italy is used in positron emission tomography (PET) scans in adult male patients with prostate diseases.
The active substance in Fluorocholine (F) Curium Italy enables visualization of specific parts of your body and allows images to be captured.
This PET scan is performed to help determine how to manage the disease you have or are suspected to have.
The use of fluorocholine (F) involves exposure to a small amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit obtained from the radiopharmaceutical procedure outweighs the risk associated with radiation exposure.
2. What you should know before using Fluorocholine (F) Curium Italy
Fluorocholine (F) Curium Italy must not be used
- if you are allergic to fluorocholine (F) or to any of the other ingredients of this medicine (listed in section 6).
- if you are pregnant.
Warnings and precautions
Before administration of Fluorocholine (F) Curium Italy you must:
- fast for at least 4 hours.
- drink plenty of water before the start of the examination to ensure adequate hydration and urinate as frequently as possible during the first hour after the examination.
Children and adolescents
Fluorocholine (F) Curium Italy is not indicated in children.
Other medicines and Fluorocholine (F) Curium Italy
Inform the nuclear medicine physician if you are taking, have recently taken, or might take any other medicines, as they could interfere with the interpretation of the images, particularly:
- if you are undergoing antiandrogen therapy.
- if you have undergone chemotherapy.
- if you have been treated with medicines used to increase blood cell production.
- if you have been treated with chloroquine (e.g. for gout).
If in doubt, please consult the nuclear medicine specialist performing the PET examination for further information.
Fluorocholine (F) Curium Italy with food and drinks
You must remain fasting for at least 4 hours before administration of Fluorocholine (F) Curium Italy, as certain types of food may reduce image quality.
Pregnancy and breastfeeding
Fluorocholine (F) Curium Italy is not indicated in women.
Driving and using machines
Fluorocholine (F) Curium Italy is unlikely to affect your ability to drive or operate machinery.
Fluorocholine (F) Curium Italy contains sodium
This medicine contains sodium (3.54 mg/mL). Depending on the injected volume, the limit of 1 mmol (23 mg) of sodium per administered dose may be exceeded. This should be taken into consideration if you are on a low-sodium diet.
3. How Fluorocholine (F) Curium Italy is used
There are strict regulations governing the use, handling, and disposal of radiopharmaceuticals.
Fluorocholine (F) Curium Italy will be used only in specially controlled areas. This product must be handled and administered only by trained and qualified personnel who are experienced in its safe use. These individuals will pay particular attention to the safe handling of this product and will keep you informed about their actions.
The nuclear medicine physician supervising the procedure will determine the amount of Fluorocholine (F) Curium Italy to be used in your case. This will be the smallest amount necessary to obtain the required information.
Dosage
The dose to be administered is determined based on your body weight and depends on the type of imaging camera used to capture images of your body.
The recommended activity ranges from 100 MBq to 400 MBq for an adult weighing 70 kg. MBq stands for megabecquerel and is the unit of measurement for radioactivity.
Administration of Fluorocholine (F) Curium Italy and procedure performance
Fluorocholine (F) Curium Italy is administered by intravenous injection.
A single injection is sufficient to perform the examination required by the physician.
After the injection, you will be advised to drink fluids and will be asked to urinate immediately before the test.
Duration of the procedure
The nuclear medicine physician will inform you about the usual duration of the procedure.
After receiving Fluorocholine (F) Curium Italy you must:
- avoid any close contact with young children and pregnant women for the 12 hours following the injection;
- urinate frequently to help eliminate the product from your body.
The nuclear medicine physician will inform you about any specific precautions you should take after receiving this medicinal product. If you have any doubts, please consult your nuclear medicine physician.
If you have been given more Fluorocholine (F) Curium Italy than you should have received
An overdose is unlikely, as you will receive only a single dose of Fluorocholine (F) Curium Italy, carefully controlled by the nuclear medicine physician supervising the procedure.
However, in the event of an overdose, you will receive appropriate treatment. In particular, the nuclear medicine physician supervising the procedure may recommend that you drink plenty of fluids to help eliminate radioactivity from your body.
If you have any further questions about the use of Fluorocholine (F) Curium Italy, please consult the nuclear medicine specialist supervising your examination.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
To date, no adverse events have been observed.
This radiopharmaceutical will deliver low amounts of ionising radiation, associated with the lowest possible risk of cancer and hereditary abnormalities.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your nuclear medicine physician. You can also report side effects via the website: http://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Fluorocolina (F) Curium Italy
You must not store this medicinal product. This medicinal product is stored under the responsibility of a specialist in appropriate premises. Radiopharmaceuticals shall be stored in accordance with national regulations on radioactive materials.
6. Contents of the pack and other information
What Fluorocolina (F) Curium Italy contains
- The active substance is fluorocholine (F). One mL of injectable solution contains 225 MBq at the date and time of calibration.
- The other components are: sodium chloride and water for injectable preparations.
Appearance of Fluorocolina (F) Curium Italy and contents of the pack
You must not handle this medicinal product. The following information is provided for your information only.
Fluorocolina (F) Curium Italy is a clear, colourless liquid.
The activity per vial ranges between 112 MBq and 3,375 MBq at the date and time of calibration.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Curium Italy S.r.l.
Via Nicola Piccinni, 2
I-20131 Milan, Italy
Manufacturers
CIS BIO INTERNATIONAL
PARC SCIENTIFIQUE ET TECHNIQUE G. BESSE
180, ALLEE VON NEUMANN
30035 NÎMES CEDEX 1
FRANCE
CIS BIO INTERNATIONAL
HÔPITAL XAVIER ARNOZAN
AVENUE DU HAUT LEVÊQUE
33600 PESSAC
FRANCE
CIS BIO INTERNATIONAL
CENTRE EUGENE MARQUIS
AVENUE DE LA BATAILLE FLANDRES DUNKERQUE
35042 RENNES CEDEX
FRANCE
CIS BIO INTERNATIONAL
10 AVENUE CHARLES PEGUY
95200 SARCELLES
FRANCE
CIS BIO INTERNATIONAL
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
CURIUM PHARMA SPAIN, S.A.
PARQUE TECNOLÓGICO CARTUJA'93
AVDA. THOMAS A. EDISON S/N
41092 SEVILLE
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
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Belgium, France, Luxembourg, Netherlands, Malta: Fluorocholine (F) CIS bio international
Portugal, Spain: Fluorocolina (F) CIS bio international
Slovenia: [F] fluoroholin CIS bio international
Italy: Fluorocolina (F) Curium Italy
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco - AIFA).
The following information is intended exclusively for healthcare professionals:
The full product characteristics summary of Fluorocolina (F) CIS bio
international is provided in the packaging as a separate document, aimed at providing
healthcare professionals with additional scientific and practical information on the administration and use
of this radiopharmaceutical.
Refer to the product characteristics summary.