RADELUMIN 2000 MBq/mL INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the Patient

Radelumin 2000MBq/ml injectable solution

PSMA-1007 (18F)

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

Read all of this leaflet carefully before you are given this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or the nuclear medicine doctor supervising the procedure.
• If you get any side effects, talk to your doctor or the nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

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

1. What is Radelumin and what is it used for

This medicine is a radiopharmaceutical for diagnostic use only.

Radelumin contains a substance called PSMA-1007 (18F). Radelumin is used in a medical imaging procedure called positron emission tomography (PET) to detect certain types of cancer cells with a protein called prostate-specific membrane antigen (PSMA) in adults with prostate cancer. This is done:

• to find out if the prostate cancer has spread to the lymph nodes and other tissues outside the prostate, before initial curative therapy (e.g., therapy that involves surgical removal of the prostate, radiotherapy)
• to identify cancer cells when there is a suspicion of recurrence of prostate cancer in patients who have received initial curative therapy

When administered to the patient, PSMA-1007 (18F) binds to cancer cells that have PSMA on their surface and makes them visible to your nuclear medicine doctor during the PET imaging procedure. This provides valuable information about your disease to your doctor and nuclear medicine doctor.

The doctor who requested the PET will inform you of the results.

The use of Radelumin involves exposure to small amounts of radioactivity. Your doctor and nuclear medicine doctor have considered that the benefit of this procedure with the radiopharmaceutical outweighs the risk of your exposure to radiation.

This medicine should only be administered under the responsibility of a doctor with specialized training in nuclear medicine.

2. What you need to know before you are given Radelumin

Do not use Radelumin

• if you are allergic to PSMA-1007 (18F) or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your nuclear medicine doctor before you are given Radelumin if you:

• have kidney or liver problems.
• are on a low-sodium diet or suffer from alcohol dependence (see section "Radelumin contains sodium, potassium, and ethanol").

Children and adolescents

Radelumin is not intended for use in children and adolescents under 18 years of age.

Other medicines and Radelumin

Tell your nuclear medicine doctor if you are taking, have recently taken, or might take any other medicines, as they may interfere with the interpretation of the images.

Pregnancy and breastfeeding

This medicine is not indicated for use in women.

Driving and using machines

It is considered unlikely that Radelumin will affect your ability to drive or use machines.

Radelumin contains sodium, potassium, and ethanol

This medicine contains up to 50 mg of sodium (main component of table/cooking salt) per dose. This is equivalent to 2.5% of the maximum recommended daily intake of sodium for an adult.

This medicine contains up to 1 mg of potassium per dose, which is less than 1 mmol per dose; this is, essentially "potassium-free".

This medicine contains up to 80 mg of alcohol (ethanol) per milliliter (ml), which is equivalent to 800 mg per dose (8% m/v). The amount per 10 ml dose of this medicine is equivalent to less than 20 ml of beer or 8 ml of wine.

3. How Radelumin is given

There are strict rules for the use, handling, and disposal of radiopharmaceuticals.

Radelumin will only be used in special controlled areas. This medicine will only be handled and administered by trained and qualified personnel to use it safely. These people will take special care in the safe use of this medicine and will inform you of their actions.

The nuclear medicine doctor supervising the procedure will decide the amount of Radelumin to be used in your case. This will be the minimum amount necessary to obtain the desired information.

The recommended dose for administration to an adult is 3.6-4.4 MBq per kilogram of body weight. The MegaBecquerel (MBq) is the unit used to express radioactivity. This means that, for a 70 kg adult, 252-308 MBq will be administered.

Administration of Radelumin and performance of the procedure

Radelumin is administered intravenously in the form of an injection into the vein.

One injection is sufficient to perform the study that your doctor needs.

Duration of the procedure

Your nuclear medicine doctor will inform you about the usual duration of the procedure. The PET will usually start between 90 and 120 minutes after administration of the Radelumin injection.

After administration of Radelumin

• Avoid direct contact with small children and pregnant women for 12 hours after the injection.

Your nuclear medicine doctor will inform you if you need to take any other special precautions after receiving the medicine. Ask your nuclear medicine doctor if you have any questions.

If you are given more Radelumin than you should

It is unlikely that an overdose will occur because you will only receive one injection of Radelumin, whose radioactivity will have been precisely determined by the nuclear medicine doctor in charge of your examination.

However, if an overdose occurs, the nuclear medicine doctor in charge of your examination will take the necessary measures to ensure that your body's exposure to radiation is maintained at a level generally accepted for diagnostic nuclear medicine or radiology examinations. These measures will vary from patient to patient depending on the clinical condition and the degree of overdose and may be limited to simple monitoring.

If you have any further questions on the use of this medicine, ask the nuclear medicine doctor supervising the procedure.

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 reported.

Administration of this radiopharmaceutical involves receiving small amounts of ionizing radiation with a low risk of developing cancer and hereditary defects.

Reporting of side effects

If you experience side effects, inform your nuclear medicine doctor, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Radelumin

You will not need to store this medicine. This medicine is stored under the responsibility of the specialist in suitable facilities. The storage of radiopharmaceuticals will be carried out in accordance with national regulations on radioactive materials.

The following information is intended only for the specialist:

Radelumin should not be used after the expiry date stated on the label of the lead container after CAD.

6. Contents of the pack and other information

Composition of Radelumin

• The active substance is PSMA-1007 (18F).
• Each milliliter of solution contains 2000 MBq of PSMA-1007 (18F) at the time and date of calibration (Cal).
• The other components are disodium phosphate, potassium dihydrogen phosphate, sodium chloride, potassium chloride, sodium ascorbate, anhydrous ethanol, and water for injections (see section 2 "Radelumin contains sodium, potassium, and ethanol").

Appearance of Radelumin and contents of the pack

You will not need to obtain this medicine or handle the packaging or vial; the following is for your information only.

Radelumin is a clear, colorless or slightly yellowish solution, which is stored in a glass vial.

Radelumin 2000 MBq/mL injectable solution, 10 mL vial: Each multidose vial contains 0.3 to 10 mL of solution, corresponding to 600-20000 MBq at the date and time of calibration (Cal).

Radelumin 2000 MBq/mL injectable solution, 15 mL vial: Each multidose vial contains 0.3 to 15 mL of solution, corresponding to 600-30000 MBq at the date and time of calibration (Cal).

Radelumin 2000 MBq/mL injectable solution, 20 mL vial: Each multidose vial contains 0.3 to 20 mL of solution, corresponding to 600-40000 MBq at the date and time of calibration (Cal).

Pack size: 1 vial.

Not all pack sizes may be marketed.

Marketing authorization holder:

ABX advanced biochemical compounds GmbH

Heinrich-Glaeser-Str. 10-14

01454 Radeberg

Germany

Manufacturer:

IRAB S.L.

Dr. Aiguader 88, planta-I

08003 Barcelona

Spain

Advanced Accelerator Applications Molecular Imaging Iberica S.L.U.

C/ Josep Anselm Clavé 100

08950 Esplugues De Llobregat

Spain (Barcelona)

Advanced Accelerator Applications Molecular Imaging Iberica S.L.U.

Ctra Madrid Cartagena Sn

El Palmar

30120 Murcia

Spain

Advanced Accelerator Applications (Portugal) Unipessoal Lda.

Rua Fonte Das Sete Bicas 170

4460-283 Matosinhos

Portugal

Advanced Accelerator Applications Molecular Imaging France

126 Rocade Sud

62660 Beuvry

France

EURO-PET GmbH

Hugstetter Str. 55

79106 Freiburg im Breisgau

Germany

PETNET Solutions S.A.S.

15 Rue des Pyrenees

91090 Lisses

France

Alliance Medical RP GmbH

Spessartstr. 9

53119 Bonn

Germany

Alliance Medical RP Sp. z o.o.

ul..Szeligowska 3

05-850 Szeligi

Poland

ITEL Telecomunicazioni S.r.l.

Via A. Labriola zona industriale SNC

70037 Ruvo di Puglia (BA)

Italy

AAA Molecular Imaging France S.A.S. Marseille

Bat Cerimed

27 Boulevard Jean Moulin

13005 Marseille

France

SPARKLE S.r.l.

Contrada Calò snc

73042 Casarano (LE)

Italy

ABX GmbH

Heinrich-Glaeser-Str. 10-14

01454 Radeberg

Germany

Radboud Translational Medicine B.V.

Geert Grooteplein 21, route 142, 6525 EZ

Nijmegen

Netherlands

Seibersdorf Labor GmbH

2444 Seibersdorf

Austria

AAA Molecular Imaging France S.A.S. Saint

Cloud

3 Rue Charles Lauer

92210 Saint-Cloud

France

Advanced Accelerator Applications Germany GmbH

Saime-Genc-Ring 18

53121 Bonn

Germany

Advanced Accelerator Applications Germany GmbH

Marchioninistrasse 67

81377 München

Germany

Advanced Accelerator Applications Molecular Imaging Italy S.r.l

Viale Dell´Industria Snc

86077 Pozzilli

Italy

Advanced Accelerator Applications Molecular Imaging Italy S.r.l.

Via Piero Maroncelli 40

47014 Meldola

Italy

Congregazione Poveri Servi Della Divina Provvidenza-Casa Buoni Fanciulli-Istituto Don Calabria

Via Don Angelo Sempreboni 5

37024 Negrar

Italy

Universitätsklinikum Tübingen

Department für Radiologie

Abteilung für Präklinische Bildgebung und Radiopharmazie

Röntgenweg 15-17

72076 Tübingen

Germany

BIONT, a.s.

Karloveská 63

842 29 Bratislava

Slovakia

Krankenhausbetriebsgesellschaft Bad Oeynhausen mbH

Georgstr. 11

32545 Bad Oeynhausen

Germany

Universitätsklinikum Leipzig AöR

Stephanstr. 9a

04103 Leipzig

Germany

VOXEL S.A.

ul. Wroclawska 1-3

30-006 Kraków

Poland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet: August 2025.

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This information is intended only for healthcare professionals:

The full technical information of Radelumin is included as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical. See the technical information.