PCOLINA 1 GBQ/ML Инъекционный раствор

Содержание инструкции

1. Pcolina 1 GBq/mL injectable solution
   1. What is Pcolina and what is it used for?
   2. What you need to know before using Pcolina?
   3. How is Pcolina used?
   4. Possible side effects
   5. How Pcolina is stored
   6. Contents of the pack and other information

Pcolina 1 GBq/mL injectable solution

Fluorocholine (F) chloride

medicine because it contains important information for you.

• If you have any doubts, ask the nuclear medicine specialist who will supervise the entire procedure.
• If any side effects occur, contact the nuclear medicine specialist.

Contents of this leaflet:

• 1. What is Pcolina and what is it used for?
• 2. What you need to know before using Pcolina?
• 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 medicine is a radiopharmaceutical for exclusively diagnostic use.
Pcolina is used for diagnostic purposes in Positron Emission Tomography (PET) and is administered
before such examination.
The active substance in Pcolina allows visualization of an increased influx of the natural substance
choline in certain specific organs or tissues, which is detected by PET and shown in the form of an
image.
Positron Emission Tomography is a technique used in nuclear medicine that provides
images of sections of living organisms. It works with a minimum quantity of radioactive drug
to produce quantitative and precise images of specific metabolic processes in the body.
The examination is performed to decide on the most appropriate therapeutic plan for the disease you
have or are suspected of having.

2. What you need to 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 medicine (listed in section 6)
• If you are pregnant.

Warnings and precautions
You must take particular care with Pcolina

• if you are pregnant or think you may be pregnant,
• if you are breastfeeding,
• if you have kidney problems: in this case, very careful indication is required as you may be exposed to higher levels of radiation,
• if you come into contact with newborns: it is recommended to avoid close contact between the patient and newborns in the first 12 hours after the injection.

Before the administration of Pcolina you must:

• Drink plenty of water before the examination so that you urinate as often as possible in the first few hours after the study.
• Be fasting for at least 4 hours.

Children and adolescents
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 may
take other medicines, as they may interfere with the interpretation of the images by
the doctor: in particular if you are taking or have taken medicines for antiandrogen therapy.
If in doubt, consult the nuclear medicine specialist who is performing the PET scan, for
more information.

Pcolina with food and drink
You must remain fasting for at least 4 hours before the administration of Pcolina. Drink plenty of
water.

Pregnancy and breastfeeding
You must inform the nuclear medicine specialist before the administration of Pcolina if there is
a possibility of pregnancy, if you have missed your menstrual period or if you are breastfeeding.
In case of doubt, it is important to consult the nuclear medicine specialist who will supervise the
procedure.
If you are pregnant
If you are pregnant, Pcolina must not be administered to you.
The nuclear medicine specialist will only administer this product during pregnancy if the
expected benefit outweighs the risks.
If you are breastfeeding
If administration is unavoidable during breastfeeding, milk can be collected before
the injection and stored for later use. Breastfeeding must be interrupted for at least
12 hours. The milk produced during this period must be discarded.
Ask the nuclear medicine specialist when you can resume breastfeeding.

Driving and using 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,
be greater than 1 mmol (23 mg). This must be taken into consideration in patients who are following
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 special controlled areas. The product must be handled and administered only by
expert and qualified personnel trained to use it safely. Personnel will take due precautions
for the safe use of the medicine and will inform you about the actions taken.
The nuclear medicine specialist supervising the procedure will decide the amount of Pcolina to
use in your case. However, it will always be the minimum amount necessary to obtain the desired
information.
The amount to be administered usually recommended for an adult, ranges from 200 to 500 MBq
(megabecquerel is the unit of measure used for radioactivity).

Administration of Pcolina and performance of the procedure
Pcolina is administered by intravenous injection.
A single injection is sufficient to perform the examination necessary for the doctor.
After the injection, you will be offered a drink and asked to urinate immediately before the examination.

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

After the administration of Pcolina you must:

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

The nuclear medicine specialist will tell you if you need to take special precautions after taking the
medicine. If you have any doubts, please contact the nuclear medicine specialist.

If you have been given more Pcolina than you should
An overdose is unlikely as you will be given a single dose of Pcolina
carefully controlled by the nuclear medicine specialist who is in charge of your examination. However, in
the event of an overdose, you will receive appropriate treatment. In particular, the nuclear medicine
specialist in charge of the examination may recommend that you drink plenty of fluids to facilitate
the elimination of Pcolina from your body (in fact, the main elimination of this medicine
occurs via the kidneys, in the urine).
It may be necessary to take diuretics.
If you have further questions about the use of Pcolina, please contact the nuclear medicine specialist who
supervises the examination.

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.
This radiopharmaceutical will release a low amount of ionizing radiation associated with a minimal risk of cancer and hereditary abnormalities.
Your doctor has assessed that the clinical benefit obtained from the examination with the radiopharmaceutical outweighs the risk due to radiation.

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 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 must not store this medicine. This product is stored in suitable premises under the responsibility of the specialist. The storage of radiopharmaceuticals will take place in accordance with national regulations on radioactive materials.
The following information is intended solely for the specialist.
This product must not be used after the expiry date stated on the label.

6. Contents of the pack and other information

What containsPcolina

• The active substance is fluoromethyl-( F)-dimethyl-2-hydroxyethyl-ammonium chloride (or fluorocholine ( F) chloride).
• 1 mL of injectable solution contains 1000 MBq of fluorocholine ( 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 the medicine independently or handle the packaging or the vial. The following information is provided for informational purposes only.
Pcolina is a transparent and colorless liquid.
The activity per vial is between 500 MBq and 15000 MBq at the date and time of calibration.

Marketing Authorisation 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 Roma
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 authorised in the member states of the EEA with 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
The following information is intended exclusively for physicians or healthcare professionals:
The full Summary of Product Characteristics of Pcolina is provided as a separate document
in the product packaging, in order to provide healthcare professionals with further scientific and practical information relating to 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)