Iasoglio

IASOglio, 2 GBq/ml, solution for injection
Fluoroethyl-L-tyrosinum ( F)
The patient should carefully read the information in this leaflet before the administration of the medicinal product – it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any further questions, please consult the nuclear medicine physician supervising the procedure.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your nuclear medicine physician. See section 4.

Leaflet contents

1. What IASOglio is and what it is used for
2. Important information before use of IASOglio
3. How to use IASOglio
4. Possible side effects
5. How to store IASOglio
6. Contents of the packaging and other information

1. What IASOglio is and what it is used for

Pharmacotherapeutic group ATC code: V09IX10.
This medicine is a radiopharmaceutical product intended solely for diagnostic purposes.
IASOglio is used in diagnostic imaging with positron emission tomography (PET). IASOglio is administered prior to such imaging.
The radioactive substance contained in IASOglio is detected and visualized by PET.
Positron Emission Tomography is an imaging technology used in nuclear medicine that enables cross-sectional images of living organisms to be obtained. It uses small amounts of radioactive pharmaceuticals to generate precise images showing specific metabolic processes in the body. The examination aims to assist in making decisions regarding the treatment of a suspected or confirmed disease.
The use of IASOglio involves exposure to small amounts of radiation. The nuclear medicine physician has determined that the clinical benefits obtained from the procedure using the radiopharmaceutical outweigh the radiation risk to the patient.

2. Important information before using IASOglio

IASOglio must not be used:

• in case of hypersensitivity to fluoroethyl-L tyrosine (F) or any of the other components of this medicinal product (listed in section 6),
• during pregnancy.

Warnings and precautions
Special caution must be exercised when using IASOglio. Inform the nuclear medicine physician if:

• the patient is pregnant or suspects she may be pregnant,
• the patient is breastfeeding.

Before administration of IASOglio, the patient should:

• drink plenty of water to ensure adequate hydration before the examination, so as to urinate as frequently as possible immediately after the examination,
• refrain from eating for at least 4 hours.

Children and adolescents
Inform the nuclear medicine physician if the patient is under 18 years of age.

IASOglio and other medicines
Tell the nuclear medicine specialist about all medicines currently used or recently taken, as well as any medicines the patient plans to take, as they may affect the interpretation of results.

IASOglio with food and drink
The patient should remain fasting for at least 4 hours before the examination. The patient should drink large amounts of water. IASOglio contains alcohol. This should be taken into account in patients with alcohol-related disease, breastfeeding women, children, and patients in high-risk groups, such as those with liver disease or epilepsy.

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a nuclear medicine physician. Before administering IASOglio, inform the nuclear medicine specialist if there is any possibility that the patient is pregnant, if menstruation has not occurred, or if the patient is breastfeeding. In case of doubt, advice must be sought from the supervising nuclear medicine physician.
If the patient is pregnant:
This medicinal product is administered during pregnancy only if the expected benefits outweigh the potential risks.
If the patient is breastfeeding:
Breast milk may be expressed and stored before administration of the medicinal product. Breastfeeding must be interrupted for at least 12 hours. Breast milk collected during this period must be discarded. Consult the nuclear medicine physician regarding when breastfeeding may be resumed.

Driving and operating machinery
The effect of IASOglio on the ability to drive or operate machinery is considered unlikely.

IASOglio contains sodium and ethanol
This preparation may contain more than 1 mmol of sodium (23 mg). This should be taken into account in patients on a low-sodium diet. One dose of this medicinal product contains up to 0.8 g of ethanol (alcohol). This amount may increase blood alcohol concentration by up to 0.02 g/L (2 mg/100 mL), equivalent to 20 mL of beer or 8 mL of wine per dose in adults. This should be taken into account in patients with alcohol-related disease, breastfeeding women, children, and patients in high-risk groups, such as those with liver disease or epilepsy.

3. How to use IASOglio?

The use, handling, and disposal of radiopharmaceuticals are subject to strict regulations. The use of IASOglio is permitted only in specially controlled facilities. Only appropriately trained and qualified personnel are authorized to handle and administer the product. These personnel will ensure the safe use of the product and provide the patient with detailed information about the procedures performed.
The decision on the dose of IASOglio in an individual case will be made by the supervising nuclear medicine physician. This will be the smallest possible dose necessary to obtain the required information.
The recommended administered dose for an adult ranges from 180 to 250 MBq (depending on the patient's body weight, type of imaging equipment used, and imaging mode). Megabecquerel (MBq) is a unit used to express radioactivity.

Use in children and adolescents
The dose used in children and adolescents depends on the patient's body weight.

Administration of IASOglio and the course of the examination
IASOglio is administered intravenously.
A single administration is sufficient for the examination.
After administration, the patient is asked to drink water and then to empty the bladder immediately before the examination.

Duration of the procedure
The nuclear medicine physician will inform the patient about the typical duration of the procedure.

After administration of IASOglio, the patient should:

• avoid close contact with young children and pregnant women for 12 hours,
• urinate frequently to eliminate the medicinal product from the body.
  If special precautions are required after administration, the patient will receive appropriate instructions from the nuclear medicine physician. For any questions, contact the nuclear medicine physician.

Administration of a higher than recommended dose of IASOglio:
Overdose is unlikely, as the single dose of IASOglio is precisely controlled by the supervising nuclear medicine physician. However, in the event of overdose, appropriate treatment will be administered. Elimination of radioactive components should be maximized. The patient should drink as much water as possible and urinate frequently. Diuretics may be used if necessary. For any additional questions regarding the use of IASOglio, consult the supervising nuclear medicine physician.

4. Possible adverse reactions

Like all medicines, this medicinal product may cause adverse reactions, although not everybody will experience them.
To date, no serious adverse reactions have been observed.
The administered dose of ionizing radiation is calculated to minimize the risk of inducing tumours and the potential development of hereditary defects.
The nuclear medicine physician has determined that the clinical benefits obtained from the procedure using the radiopharmaceutical outweigh the risks associated with radiation exposure.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the nuclear medicine specialist who supervised the examination.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of this medicinal product.

5. How to store IASOglio
IASOglio will not be stored by patients. The product will be stored under the supervision of qualified medical personnel in appropriate facilities.
Storage of radiopharmaceuticals complies with national regulations concerning radioactive materials.
The following information is intended exclusively for qualified medical personnel.
IASOglio must not be used after the expiry date stated on the label after "EXP".

6. Contents of the packaging and other information
Composition of IASOglio

• The active substance is fluoroethyl-L-tyrosine (F). One ml contains 2 GBq of fluoroethyl-L-tyrosine (F) at the reference date and time.
• The other components are water for injections, sodium chloride, sodium ascorbate, and anhydrous ethanol.

What IASOglio looks like and contents of the container
IASOglio is a clear, colourless or pale yellow solution. One vial with a capacity of 15 ml contains 0.2 to 11 ml of solution, corresponding to 0.4 to 22 GBq at calibration time. One vial with a capacity of 25 ml contains 0.2 to 20 ml of solution, corresponding to 0.4 to 40 GBq at calibration time.

Marketing Authorization Holder
Curium Austria GmbH
Grazer strasse 18
A-8071 Hausmannstaetten
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
Seilerstaette 4
4020 Linz
Austria
Synektik Pharma Sp. z o.o.
ul. Artwińskiego 3
25-734 Kielce
Poland
Curium PET France – Sarcelles
10 avenue Charles Peguy
95200 Sarcelles
France
Curium PET France
Biopole Clermont-Limagne
3 Rue Marie Curie
63 360 Saint-Beauzire
France
CURIUM PET FRANCE - PESSAC
Chu xavier arnozan
Avenue du haut-leveque
33604 Pessac
France
CURIUM PET FRANCE - NIMES
Parc scientifique georges besse
180, allee von neumann
30000 Nimes
France
CURIUM PHARMA SPAIN S.A.
C/ manuel bartolome cossio, 10
E-28040 Madrid
Spain
SYN INNOVATION LABORATORIES
Sousaki site ag. Theodoroi,
Korinthia prefecture 20003
Greece
OFFICINA FARMACEUTICA DELL’ISTITUTO DI FISIOLOGIA CLINICA
Via GIUSEPPE MORUZZI 1
56124 Pisa
Italy

The product described is authorized for marketing in the EEA Member States under the following names:
France: IASOglio 2 GBq/mL, solution for injection

Other sources of information
Detailed information on this product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: http://www.urpl.gov.pl.
Information intended exclusively for healthcare professionals:
The full Summary of Product Characteristics (SmPC) for IASOglio is provided as a separate document inside the product packaging, to provide healthcare professionals with additional scientific and practical information regarding the administration and use of this radiopharmaceutical.
Please refer to the aforementioned Summary of Product Characteristics.