Sodium fluoride (18F) Curium Austria

PACKAGE LEAFLET

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT

Sodium fluoride (F) Curium Austria 2.0 GBq/mL, injectable solution

Sodium fluoride-(F)
Please read this leaflet carefully before you are administered this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult the nuclear medicine physician supervising the procedure.
• If you experience any side effects, including those not listed in this leaflet, contact the nuclear medicine physician. See section 4.

Contents of this leaflet:

1. What Sodium fluoride (F) Curium Austria is and what it is used for
2. What you need to know before Sodium fluoride (F) Curium Austria is used
3. How Sodium fluoride (F) Curium Austria is used
4. Possible side effects
5. How Sodium fluoride (F) Curium Austria is stored
6. Package contents and other information

1. What Sodio fluoruro (F) Curium Austria is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.
Sodio fluoruro (F) Curium Austria is used for diagnosis in Positron Emission Tomography (PET) scans and is administered prior to such examination.
The radioactive substance in Sodio fluoruro (F) Curium Austria (to demonstrate bone metabolism) is detected by PET and displayed as an image.
Positron Emission Tomography is an imaging technology used in nuclear medicine that produces cross-sectional images of living organisms. It works by using small amounts of radioactive medicine to generate quantitative and precise images of specific metabolic processes in the body. This examination is performed to help determine how to treat the disease you have or are suspected to have.
The use of Sodio fluoruro (F) Curium Austria involves exposure to small amounts of radioactivity.
Your nuclear medicine physician has determined that the clinical benefit obtained from the procedure with this radiopharmaceutical outweighs the risk associated with radiation exposure.

2. What you need to know before Sodio fluoruro (F) Curium Austria is used

Do not use Sodio fluoruro (F) Curium Austria

• if you are allergic to sodium fluoride (F) or to any of the other ingredients of this medicine (listed in section 6).
• if you are pregnant.

Warnings and precautions
Exercise particular caution with Sodio fluoruro (F) Curium Austria
Inform the nuclear medicine physician in the following cases:

• if you are pregnant or suspect you may be pregnant
• if you are breastfeeding

Before administration of Sodio fluoruro (F) Curium Austria you must

• drink plenty of water and be well hydrated before the start of the examination, so as to urinate as frequently as possible during the first hour after the study.

Children and adolescents
Inform the nuclear medicine physician if you are under 18 years of age.
Other medicines and Sodio fluoruro (F) Curium Austria
Inform the nuclear medicine physician if you are taking, have recently taken, or might take any other medicines, as these could interfere with the interpretation of the images.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your nuclear medicine physician before receiving this medicine.
You must inform the nuclear medicine physician before administration of Sodio fluoruro (F) Curium Austria if there is any possibility you may be pregnant, if you have missed a menstrual period, or if you are breastfeeding.
If you have any doubts, it is important to consult the nuclear medicine physician supervising the procedure.
If you are pregnant:
The nuclear medicine physician will administer this product during pregnancy only if the expected benefit outweighs the potential risks.
If you are breastfeeding:
Breast milk may be expressed before the injection and stored for later use. Breastfeeding must be discontinued for at least 12 hours. Milk produced during this period must be discarded.
Ask your nuclear medicine physician when you can resume breastfeeding.
Driving and using machines
It is considered unlikely that Sodio fluoruro (F) Curium Austria affects the ability to drive vehicles or operate machinery.
Sodio fluoruro (F) Curium Austria contains sodium.
This medicine may contain more than 1 mmol of sodium (23 mg). This should be taken into account if you are on a low-sodium diet.

3. How Sodio fluoruro (F) Curium Austria is used

There are strict laws regulating the use, handling, and disposal of radiopharmaceuticals. Sodio fluoruro (F) Curium Austria will only be used in a hospital setting. This product must be handled and administered only by trained and qualified personnel experienced in its use and familiar with radiation safety procedures. These individuals will pay particular attention to the safe use of this product and will keep you informed about their actions.

The nuclear medicine physician supervising the procedure will determine the amount of Sodio fluoruro (F) Curium Austria to be used in your case. The smallest necessary amount required to obtain the desired diagnostic information will be administered.

The recommended administered activity for an adult normally ranges from 100 MBq to 400 MBq (megabecquerel is the unit used to express radioactivity).

Use in children and adolescents
In children and adolescents, the administered amount will be adjusted according to the child's or adolescent's body weight.

Administration of Sodio fluoruro (F) Curium Austria and performance of the procedure
Sodio fluoruro (F) Curium Austria is administered intravenously.
A single injection is sufficient to perform the test required by the physician.
After the injection, you will be encouraged to drink fluids and will be asked to urinate immediately before the imaging procedure.

Duration of the procedure
Your nuclear medicine physician will inform you about the expected duration of the procedure.

After administration of Sodio fluoruro (F) Curium Austria you must

• avoid close contact with young children and pregnant women for 12 hours following the injection.
• urinate frequently to help eliminate the product from your body.

Your nuclear medicine physician will inform you about any special 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 Sodio fluoruro (F) Curium Austria than you should have received
An overdose is unlikely, as you will receive only a single, carefully controlled dose of Sodio fluoruro (F) Curium Austria, administered under the supervision of the nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be given.
Elimination of the radioactive components should be enhanced as much as possible. You should drink as much fluid as possible and empty your bladder frequently. Diuretics may be required.

If you have any further questions about the use of Sodio fluoruro (F) Curium Austria, please consult the nuclear medicine physician supervising the procedure.

4. Possible side effects

Like all medicines, this medicinal product may cause side effects, although not everybody gets them.
To date, no serious adverse events have been observed.
The radiopharmaceutical administered will deliver low amounts of ionising radiation, with the lowest possible risk of cancer and hereditary abnormalities.
The nuclear medicine physician has considered that the clinical benefit obtained from the procedure using the radiopharmaceutical outweighs the risk associated with radiation exposure.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your 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 medicinal product.

5. How Sodium fluoride (F) Curium Austria is stored

You must not store this medicinal product. This medicinal product is stored under the responsibility of specialists in suitable premises. Radioactive medicinal products must be stored in accordance with national regulations concerning radioactive materials.
The following information is intended exclusively for specialists.
Sodium fluoride (F) Curium Austria must not be used after the expiry date stated on the label.

6. Package contents and other information

What Sodio fluoruro ( F) Curium Austria contains

• The active substance is sodium fluoride ( F). 1 mL contains 2.0 GBq of sodium fluoride ( F) at the date and time of calibration.
• The other components are water for injectable solutions, sodium chloride and potassium dihydrogen phosphate.

Description of the appearance of Sodio fluoruro ( F) Curium Austria and contents of the pack
A 15 mL multidose vial contains 0.37–15.0 mL of solution corresponding to 0.74–30 GBq at the time of calibration.
A 25 mL multidose vial contains 0.37–22.0 mL of solution corresponding to 0.74–44 GBq at the 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. Veiterstr. 47
9020 Klagenfurt
Austria
Curium Austria GmbH
Seilerstätte 4
4020 Linz
Austria
Advanced Accelerator Applications SA
Technopole de l’Aube
14 Rue Gustave Eiffel
10430 Rosières près Troyes
France
Advanced Accelerator Applications SA
Via Ribes, 5
10010 Colleretto Giacosa (TO)
Italy
Zakład Produkcji Radiofarmaceutyków IASON Sp. z o.o.
ul. Artwińskiego 3
25-734 Kielce
Poland
IASON ITALIA s.r.l.
Via Gastone Maresca 38/38A
00138 Roma
Italy

This medicinal product is authorized in the European Economic Area Member States
under the following names:
Austria IASOfluorid 2.0 GBq/mL - Injektionslösung
France IASOflu 2.0 GBq/mL, solution injectable
Germany IASOflu 2.0 GBq/mL Injektionslösung
Italy Sodio fluoruro ( F) Curium Austria 2.0 GBq/mL, soluzione iniettabile

Further sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (http://www.agenziafarmaco.gov.it/).

The following information is intended for healthcare professionals only:
The complete product information for Sodio fluoruro ( F) Curium Austria is provided inside the package as a separate document, intended to supply healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.
Refer to the product information leaflet.