FLUOROCOLINA 225 MBq/mL Injectable solution

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1. Fluorocolina ( F) Curium Italy 225 MBq/mL injectable solution
   1. What is Fluorocolina (F) Curium Italy and what is it used for
   2. What you need to know before using Fluorocolina ( F) Curium Italy
   3. How Fluorocolina ( F) Curium Italy is used
   4. Possible side effects
   5. How to store Fluorocolina ( F) Curium Italy
   6. Contents of the pack and other information

Fluorocolina ( F) Curium Italy 225 MBq/mL injectable solution

Fluorocolina ( F) chloride

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 questions, ask your doctor or the nuclear medicine specialist who will supervise the entire procedure.
• If any side effects occur, including those not listed in this leaflet, tell your nuclear medicine doctor. See section 4. Contents of this leaflet
• 1. What Fluorocolina ( F) Curium Italy is and what it is used for
• 2. What you need to know before you use Fluorocolina ( F) Curium Italy
• 3. How Fluorocolina ( F) Curium Italy is used
• 4. Possible side effects
• 5. How to store Fluorocolina ( F) Curium Italy
• 6. Contents of the pack and other information

1. What is Fluorocolina (F) Curium Italy and what is it used for

This medicine is a radiopharmaceutical for diagnostic use only. Fluorocolina (F) Curium
Italy contains the active substance fluorocholine (F).
Fluorocolina (F) Curium Italy is used for positron emission tomography (PET) scans in adult male patients suffering from prostate diseases.
The active substance in Fluorocolina (F) Curium Italy allows visualization of specific parts of
your body and to capture images.
This PET scan is performed to help decide how to treat the disease you have or
are suspected of having.
The use of fluorocholine (F) involves exposure to a small amount of radioactivity .
Your doctor and the nuclear medicine physician have assessed that the clinical benefit obtained from
the procedure with the radiopharmaceutical outweighs the risk due to radiation.

2. What you need to know before using Fluorocolina ( F) Curium Italy

Fluorocolina(F) Curium Italymust not be used

• if you are allergic to fluorocolina ( F) or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant. Warnings and precautionsBefore the administration of Fluorocolina(F) Curium Italyyou must:
• be fasting for at least 4 hours.
• drink plenty of water before the start of the examination so as to be well hydrated and urinate as often as possible during the first hour after the study. Children and adolescentsFluorocolina ( F) Curium Italy is not indicated in children. Other medicines and Fluorocolina(F) Curium ItalyInform the nuclear medicine doctor if you are taking, have recently taken or might take any other medicines, as these could interfere with the interpretation of the images by the doctor, in particular:
• if you are undergoing antiandrogen therapy.
• if you have been treated with 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 you have any doubts, consult the specialist doctor in nuclear medicine who is performing the PET scan for more information. Fluorocolina (F) Curium Italywith food and drinkYou will need to remain fasting for at least 4 hours before the administration of Fluorocolina ( F) Curium Italy because some types of food can decrease the quality of the images. Pregnancy and breastfeedingFluorocolina ( F) Curium Italy is not indicated in women.

Driving and operating machinery
It is unlikely that Fluorocolina ( F) Curium Italy will impair the ability to drive vehicles or
operate machinery.

Fluorocolina (F) Curium Italycontains sodium.
This medicine contains sodium (3.54 mg/mL). Based on the volume injected, the limit of 1 mmol (23 mg) of sodium per administered dose may be exceeded. This must be
taken into consideration if you are following a low sodium diet.

3. How Fluorocolina ( F) Curium Italy is used

There are strict laws regulating the use, handling and disposal of
radiopharmaceuticals.
Fluorocolina ( F) Curium Italy will only be used in special controlled areas. This product
must only be handled and administered by personnel prepared and qualified to use it
respecting safety criteria. These people will take particular care in the safe use of this
product and will keep you informed of their actions.
The nuclear medicine physician supervising the procedure will decide the amount of
Fluorocolina ( F) Curium Italy to use in your case. It will be the smallest amount necessary
to obtain the desired information.

Dosage
The amount to be administered is determined based on your body weight and depends on the
type of camera used to capture images of the body.
The recommended activity ranges from 100 MBq to 400 MBq for an adult weighing 70 kg. MBq
means megabecquerel and is the unit of measure for radioactivity.

Administration of Fluorocolina(F) Curium Italyand procedure execution
Fluorocolina ( F) Curium Italy is administered by intravenous injection.
One injection is sufficient to perform the examination necessary for the doctor.
After the injection, you will be given something to drink and asked to urinate immediately before the
test.

Procedure duration
The nuclear medicine physician will inform you about the usual duration of the procedure.

After the administration of Fluorocolina (F) Curium Italyyou must:

• avoid close contact with young children and pregnant women for the 12 hours following the injection
• urinate frequently to eliminate the product from the body. The nuclear medicine physician will inform you about any particular precautions you should take after receiving this medicine. If you have any doubts, consult the nuclear medicine physician. If you have been given more Fluorocolina(F) Curium Italythan you shouldAn overdose is unlikely as you will only receive a single dose of Fluorocolina ( 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 facilitate the elimination of radioactivity from the body.
If you have further questions about the use of Fluorocolina ( F) Curium Italy, consult the
specialist physician in nuclear medicine who supervises the examination.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
No adverse events have been observed to date.
This radiopharmaceutical will deliver low doses of ionizing 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,
please inform your nuclear medicine physician. You can also report side effects
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 medicine. This medicine is stored under the responsibility of the specialist in appropriate premises. Radiopharmaceuticals will 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 ingredient is fluorocoline ( F) .1 mL of injectable solution contains 225 MBq at the date and time of calibration
• The other ingredients are: sodium chloride and water for injections.

Appearance of Fluorocolina(F) Curium Italy and contents of the pack
You must not handle this medicine. The following information is for your information only.
Fluorocolina ( F) Curium Italy is a clear and colorless liquid.
The activity per vial is 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 Milano

Manufacturer
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 ROMA
ITALY

CURIUM ITALY S.R.L.
PIAZZALE SANTA MARIA DELLA MISERICORDIA 15,
33100 UDINE
ITALY

CURIUM PHARMA SPAIN, S.A.
PARQUE TECNOLÔGICO CARTUJA'93
AVDA. THOMAS A. EDISON S/N
41092 SIVIGLIA
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
NETHERLANDS

This medicinal product is authorised in the Member States of the European Economic
Area with the following denominations:
Belgium, France, Luxembourg,Netherlands, Malta:Fluorocholine ( F) CIS bio
international

Portugal, Spain:Fluorocolina ( F) CIS bio international

Slovenia: [F] fluoroholine CIS bio international

Italy:Fluorocolina ( F) Curium Italy
More detailed information on this medicine is available on the website of the Italian Medicines Agency (Italy).
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The following information is intended exclusively for healthcare professionals:
The summary of product characteristics complete of Fluorocolina ( F) CIS bio
international is provided in the package as a separate document, with the aim of providing
healthcare professionals with further scientific and practical information on the administration and use of
this radiopharmaceutical.
Refer to the summary of product characteristics.