Iasoglio

PATIENT INFORMATION LEAFLET

Patient Information Leaflet: Information for the Patient

IASOglio, 2 GBq/ml, Solution for Injection

Fluoroethyl-L-tyrosine (F)

Before Using the Medication, the Patient Should Carefully Read the Contents of the Leaflet - It Contains Important Information for the Patient.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of additional questions, the patient should contact the supervising nuclear medicine physician.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, they should inform the nuclear medicine physician. See section 4.

Table of Contents of the Leaflet

• 1. What is IASOglio and What is it Used For
• 2. Important Information Before Using IASOglio
• 3. How to Use IASOglio
• 4. Possible Adverse Reactions
• 5. How to Store IASOglio
• 6. Package Contents and Other Information

1. What is IASOglio and What is it Used For

Pharmacotherapeutic Group: ATC Code V09IX10.
This Medication is a Radio-pharmaceutical Product, Intended Exclusively for Diagnostic Purposes.
IASOglio is Used for Diagnostic Imaging in Positron Emission Tomography (PET) Studies. IASOglio is Administered Before Such a Study.
The Radioactive Substance Contained in IASOglio is Detected and Visualized by PET.
Positron Emission Tomography is a Medical Imaging Technique that Allows for the Acquisition of Cross-Sectional Images of Living Organisms, Using Small Amounts of Radioactive Pharmaceutical Substances to Produce Precise Images of Specific Metabolic Processes in the Body. The Study Aims to Help Make Decisions About the Treatment of a Confirmed or Suspected Disease.
The Use of IASOglio Involves Exposure to Small Amounts of Radiation. The Nuclear Medicine Physician has Determined that the Clinical Benefits of the Procedure Using the Radio-pharmaceutical Outweigh the Risk to the Patient Associated with Radiation.

2. Important Information Before Using IASOglio

IASOglio Should Not be Used:

• In Case of Allergy to Fluoroethyl-L-tyrosine (F) or Any Other Component of the Medication (Listed in Section 6),
• In Case of Pregnancy.

Warnings and Precautions

When Using IASOglio, Particular Caution Should be Exercised. The Patient Should Inform the Nuclear Medicine Physician if:

• The Patient is Pregnant or Suspects She May be Pregnant,
• The Patient is Breastfeeding.

Before Using IASOglio, the Patient Should:

• Drink Plenty of Water to Ensure Good Hydration Before the Study, so that Urine can be Passed as Frequently as Possible After the Study,
• Not Eat for at Least 4 Hours.

Children and Adolescents

The Patient Should Inform the Nuclear Medicine Physician if They are Under 18 Years Old.

IASOglio and Other Medications

The Patient Should Tell the Nuclear Medicine Specialist About All Medications They are Currently Taking or Have Recently Taken, as Well as Any Medications They Plan to Take, as They May Affect the Interpretation of the Results.

IASOglio with Food and Drink

Before the Study, the Patient Should Fast for at Least 4 Hours.
The Patient Should Drink Plenty of Water.
IASOglio Contains Alcohol. This Should be Taken into Account in Patients with Alcohol Dependence, Breastfeeding Women, Children, and Patients at High Risk, Such as Those with Liver Disease or Epilepsy.

Pregnancy and Breastfeeding

If the Patient is Pregnant or Breastfeeding, or Thinks She May be Pregnant, or is Planning to Have a Child, She Should Consult the Nuclear Medicine Physician.
Before Administering IASOglio, the Patient Should Inform the Nuclear Medicine Specialist if There is a Possibility that She is Pregnant, Has Not Had Her Period, or is Breastfeeding. In Case of Doubt, the Patient Should Consult the Supervising Nuclear Medicine Physician.
If the Patient is Pregnant:
This Medication is Administered During Pregnancy Only if the Expected Benefits of its Use Outweigh the Risks.
If the Patient is Breastfeeding:
Breast Milk can be Expressed Before Administering the Medication and Stored for Later Use.
Breastfeeding Should be Interrupted for at Least 12 Hours. Breast Milk Obtained During this Time Should be Discarded.
The Patient Should Ask the Nuclear Medicine Physician When Breastfeeding can be Resumed.

Driving and Operating Machinery

The Effect of IASOglio on the Ability to Drive and 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 Medication Contains a Maximum of 0.8 g of Ethanol (Alcohol). This Amount can Increase the Blood Alcohol Concentration by up to 0.02 g/L (2 mg/100 mL), Which is 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 Dependence. This Should also be Taken into Account in Breastfeeding Women, Children, and Patients at High Risk, Such as Those with Liver Disease or Epilepsy.

3. How to Use IASOglio

The Use of Radio-pharmaceutical Preparations, Handling, and Disposal are Subject to Strict Regulations. IASOglio is Only Authorized for Use in Specially Controlled Areas. Only Trained and Qualified Personnel are Authorized to Handle and Administer the Preparation. These Personnel will Ensure the Safe Use of the Preparation and will Provide the Patient with Detailed Information About the Procedures Being 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 Desired Information.
The Typical Dose Recommended for an Adult is Between 180 and 250 MBq (Depending on the Patient's Weight, the Type of Imaging Device Used, and the Imaging Mode). Megabecquerel (MBq) is a Unit Used to Express the Value of Radioactivity.

Use in Children and Adolescents

The Dose Used in Children and Adolescents Depends on the Patient's Weight.

Administration of IASOglio and Course of the Study

IASOglio is Administered Intravenously.
A Single Administration is Sufficient for the Study.
After Administration of the Preparation, the Patient is Asked to Drink Water and then Urinate Immediately Before the Study.

Duration of the Procedure

The Nuclear Medicine Physician will Inform the Patient About the Typical Duration of the Procedure.

After Using IASOglio, the Patient Should:

• Avoid Close Contact with Small Children and Pregnant Women for 12 Hours,
• Urinate Frequently to Remove the Preparation from the Body. If Special Precautions are Necessary After Administration of the Preparation, the Patient will Receive Appropriate Instructions from the Nuclear Medicine Physician. In Case of Any Questions, the Patient Should Contact the Nuclear Medicine Physician.

Use of a Higher than Recommended Dose of IASOglio:

Overdose is Unlikely, as the Single Dose of IASOglio is Carefully Controlled by the Supervising Nuclear Medicine Physician. However, in Case of Overdose, Appropriate Treatment will be Applied.
It is Necessary to Maximize the Elimination of Radioactive Substances. The Patient Should Drink as Much Water as Possible and Urinate Frequently. If Necessary, Diuretics can be Used.
In Case of Additional Questions About the Use of IASOglio, the Patient Should Contact the Supervising Nuclear Medicine Physician.

4. Possible Adverse Reactions

Like All Medications, this Medication can Cause Adverse Reactions, Although Not Everyone 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 Tumors and the Possibility of Genetic Damage.
The Nuclear Medicine Physician has Determined that the Clinical Benefits of the Procedure Using the Radio-pharmaceutical Outweigh the Risks Associated with Radiation.

Reporting Adverse Reactions

If Any Adverse Reactions Occur, Including Any Adverse Reactions Not Listed in the Leaflet, the Patient Should Inform the Nuclear Medicine Specialist Who Supervised the Study.
Adverse Reactions can be Reported Directly to the Department of Monitoring of Adverse Reactions to 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 will Help to Gather More Information on the Safety of the Medication.

5. How to Store IASOglio

IASOglio will Not be Stored by Patients. The Preparation will be Stored Under the Supervision of Qualified Medical Personnel in Appropriate Facilities.
The Storage of Radio-pharmaceuticals is Carried Out in Accordance with National Regulations Regarding Radioactive Materials.
The Following Information is Intended Exclusively for Qualified Medical Personnel.
IASOglio Should Not be Used After the Expiration Date Stated on the Label After "EXP".

6. Package Contents and Other Information

Composition of IASOglio

• The Active Substance of the Medication isFluoroethyl-L-tyrosine (F). One ml Contains 2 GBq of Fluoroethyl-L-tyrosine (F) on the Date and Time of Reference.
• Other Ingredients areWater for Injections, Sodium Chloride, Sodium Ascorbate, and Anhydrous Ethanol.

Appearance of IASOglio and Package Contents

IASOglio is a Clear, Colorless or Light Yellow Solution.
One Vial of 15 ml Contains 0.2 to 11 ml of Solution, Which Corresponds to 0.4 to 22 GBq at the Time of Calibration.
One Vial of 25 ml Contains 0.2 to 20 ml of Solution, Which Corresponds to 0.4 to 40 GBq at the Time of Calibration.

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 Medicinal Product is Authorized for Marketing in the EEA Member States Under the Following Names:

France: IASOglio 2 GBq/mL, Solution for Injection

Date of Last Revision of the Leaflet: 01.2025

Other Sources of Information

Detailed Information About this Product can be Found 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 Text of the Summary of Product Characteristics of IASOglio is Provided as a Separate Document Inside the Product Packaging to Provide Healthcare Professionals with Additional Scientific and Practical Information on the Administration and Use of this Radio-pharmaceutical Preparation.
It is Recommended to Read the Summary of Product Characteristics.