Pcolina

PACKAGE INSERT

Package insert: Information for the patient

Pcolina 1 GBq/mL solution for injection

Fluorocholine (F) chloride
Please read this package leaflet carefully before you are given this medicine, as it contains important information for you.

• Keep this package leaflet. You may need to read it again.
• If you have any questions, ask the nuclear medicine specialist who will supervise the entire procedure.
• If you experience any side effects, contact the nuclear medicine specialist. This applies to any adverse reaction, even if not listed in this package leaflet.

Contents of this leaflet:

1. What Pcolina is and what it is used for
2. What you need to know before Pcolina is used
3. How Pcolina is used
4. Possible side effects
5. How to store Pcolina
6. Contents of the pack and other information

1. What is Pcolina and what is it used for?

This medicinal product is a radiopharmaceutical intended for diagnostic use only.
Pcolina is used for diagnostic purposes in Positron Emission Tomography (PET) and is administered prior to such examination.
The active substance in Pcolina allows visualization of increased uptake of the natural substance choline in certain specific organs or tissues; this uptake is detected by PET and displayed in the form of images.
Positron Emission Tomography is a technique used in nuclear medicine that provides sectional images of living organisms. It works by using a minimal amount of radioactive medicinal product to generate quantitative and precise images of specific metabolic processes in the body.
The examination is performed to determine the most appropriate treatment plan for the disease you have or are suspected of having.

2. What you should know before using Pcolina

Pcolina must not be used

• If you are allergic (hypersensitive) to the active substance fluorocholine (F) chloride or to any of the other ingredients of this medicinal product (listed in section 6)
• If you are pregnant.

Warnings and precautions
You must exercise particular caution with Pcolina

• if you are pregnant or think you might be pregnant,
• if you are breastfeeding,
• if you have kidney problems: in this case, careful consideration is required, as you may be exposed to higher radiation levels,
• if you will be in contact with newborns: close contact between the patient and newborns should be avoided during the first 12 hours following injection.

Before administration of Pcolina you must:

• Drink plenty of water before the examination to ensure frequent urination during the first hours after the procedure.
• Fast for at least 4 hours.

Children and adolescents
Please consult the nuclear medicine specialist if you are under 18 years of age.
Other medicines and Pcolina
Inform the nuclear medicine specialist if you are taking, have recently taken, or might take any other medicines, as they could interfere with the physician's interpretation of the images; particularly if you are taking or have taken medications for antiandrogen therapy.
If in doubt, consult the nuclear medicine specialist performing the PET scan for further information.
Pcolina with food and drinks
You must remain fasting for at least 4 hours before administration of Pcolina. Drink plenty of water.
Pregnancy and breastfeeding
You must inform the nuclear medicine specialist before administration of Pcolina if there is any possibility of pregnancy, if you have missed your menstrual period, or if you are breastfeeding.
If in doubt, it is important to consult the nuclear medicine specialist supervising the procedure.
If you are pregnant
Pcolina must not be administered if you are pregnant.
The nuclear medicine specialist will administer this product during pregnancy only if the expected benefit outweighs the risks.
If you are breastfeeding
If administration during breastfeeding is unavoidable, breast milk may be collected and stored before injection for later use. Breastfeeding must be interrupted for at least 12 hours. Milk produced during this period must be discarded.
Ask the nuclear medicine specialist when you can resume breastfeeding.
Driving and use of machines
The effects on the ability to drive and use machines have not been studied.
Pcolina contains sodium
Depending on the time of injection, the sodium content may, in some cases, exceed 1 mmol (23 mg). This should be taken into consideration in patients on a low-sodium diet.

3. How is Pcolina used?

Strict regulations govern the handling, use, and disposal of radiopharmaceuticals. Pcolina will be used only in specially controlled areas. The product must be handled and administered only by experienced and qualified personnel trained in the safe use of such medicinal products. The staff will take all necessary precautions for the safe use of the medicine and will inform you about the measures taken.

The nuclear medicine specialist supervising the procedure will determine the amount of Pcolina to be used in your case. This amount will always be the minimum necessary to obtain the required diagnostic information.

The usually recommended administered activity for an adult ranges from 200 to 500 MBq (megabecquerel is the unit used to measure radioactivity).

Administration of Pcolina and performance of the procedure

Pcolina is administered by intravenous injection.
A single injection is sufficient to perform the examination required by the physician.
After the injection, you will be offered fluids to drink and will be asked to urinate immediately before the scan.

Duration of the procedure
The nuclear medicine specialist will provide you with all information regarding the usual duration of the examination.

After administration of Pcolina, you must:

• Avoid close contact with young children for the 12 hours following the injection.
• Urinate frequently to help eliminate the product from your body.

The nuclear medicine specialist will inform you if you need to take any special precautions after taking the medicine. For any doubts, please consult the nuclear medicine specialist.

If you have been given more Pcolina than you should

Overdose is unlikely, as you will receive a single dose of Pcolina carefully controlled by the nuclear medicine specialist performing your examination. However, in the event of an overdose, you will receive appropriate treatment. In particular, the nuclear medicine specialist may advise you to drink plenty of fluids to facilitate the elimination of Pcolina from your body (since the main route of elimination for this medicinal product is renal, via urine).

Diuretics may be required.

If you have any further questions about the use of Pcolina, please consult the nuclear medicine specialist supervising your examination.

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everyone experiences
them.
To date, no side effects have been observed.
This radiopharmaceutical will emit a low amount of ionizing radiation, associated with a minimal risk
of cancer and hereditary abnormalities.
Your doctor has determined that the clinical benefit obtained from the examination using the radiopharmaceutical outweighs the risk due to radiation exposure.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact the nuclear medicine physician. You may also report side effects directly through the national reporting system ( https://www.aifa.gov.it/en/content/segnalazioni-reazioni-avverse ).
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How Pcolina is stored

You should not store this medicinal product. This product is stored in suitable premises under the responsibility of the specialist. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.
The following information is intended for the specialist only.
This product must not be used after the expiry date stated on the label.

6. Package contents and other information

What Pcolina contains

• The active substance is fluoromethyl-(F)-dimethyl-2-hydroxyethyl-ammonium chloride (or fluoro-choline (F) chloride).
• 1 mL of injectable solution contains 1000 MBq of fluoro-choline (F) chloride at the date and time of calibration.
• The other ingredients are sodium chloride and water for injections.

Appearance of Pcolina and contents of the pack
The patient must not obtain or handle the medicinal product independently, nor manipulate the packaging or vial. The following information is provided for informational purposes only.
Pcolina is a colourless, clear liquid.
The activity per vial ranges between 500 MBq and 15,000 MBq at the date and time of calibration.

Marketing Authorization Holder
Curium Austria GmbH
Grazer strasse 18
A-8071 Hausmanstaetten
Austria
Tel: 0043-(0)316-284 300
Fax: 0043-(0)316-284 300-114
E-mail: [email protected]

Manufacturer
Curium Austria GmbH
St. Veiter Str. 47
9020 Klagenfurt
Austria
Curium Austria GmbH
Seilerstaette 4
4020 Linz
Austria
ADVANCED ACCELERATOR APPLICATIONS SA
20, Rue Diesel
01630 Saint-Genis-Pouilly
France
ADVANCED ACCELERATOR APPLICATIONS SA
126, Rocade Sud
62660 Beuvry
France
ADVANCED ACCELERATOR APPLICATIONS SA
3, Rue Charles Lauer
92210 Saint-Cloud
France
IASON ITALIA s.r.l
Via Gastone Maresca, 38/38A
00138 Rome
Italy
ADVANCED ACCELERATOR APPLICATIONS SA
Campus de la Timone – Bâtiment CERIMED
27, Boulevard Jean Moulin
13005 Marseille
France
Zakład Produkcji Radiofarmaceutyków
IASON Sp. z o.o.
Szaserow 128
04-141 Warsaw
Poland
Zakład Produkcji Radiofarmaceutyków
IASON Sp. z o.o.
ul. Artwińskiego 3
25-734 Kielce
Poland

This medicinal product is authorized in the EEA Member States under the following names:
Austria IASOcholine 1 GBq/mL - Injektionslösung
Belgium IASOcholine 1 GBq/mL, solution injectable
Bulgaria IASOcholine 1 GBq/mL, инжекционен разтвор
Czech Republic IASOcholine 1 GBq/ml, injekční roztok
Germany IASOcholine 1,0 GBq/ml Injektionslösung
Estonia IASOcholine 1 GBq/ml, süstelahus
France IASOcholine 1 GBq/mL, solution injectable
Italy Pcolina 1 GBq/mL, soluzione iniettabile
Lithuania Pcolina 1 GBq/mL injekcinis tirpalas
Luxembourg IASOcholine 1 GBq/mL, solution injectable
Malta IASOcholine 1 GBq/mL, solution for injection
Poland IASOcholine, 1 GBq/ml, roztwór do wstrzykiwań
Romania IASOCHOLINE 1 GBq/ml soluţie injectabilă
Slovenia IASOcholine 1 GBq/ml raztopina za injiciranje
Slovakia IASOcholine 1 GBq/ml, injekčný roztok

This Patient Information Leaflet was last revised on

The following information is intended exclusively for physicians or healthcare professionals:
The full Product Characteristics Summary for Pcolina is provided as a separate document within the product packaging, to provide healthcare professionals with additional scientific and practical information regarding the administration and use of this radiopharmaceutical.
Refer to the Summary of Product Characteristics (the Summary of Product Characteristics must be included in the packaging).