GALLIAPHARM 0.74 - 1.85 GBq RADIONUCLIDE GENERATOR

Introduction

Package Leaflet: Information for the Patient

GalliaPharm 0.74 - 1.85 GBq radionuclide generator

Gallium (68Ga) chloride solution

Read all of this leaflet carefully before you receive 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 nuclear medicine doctor who will supervise the procedure.
• If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet:

1. What is GalliaPharm and what is it used for
2. What you need to know before you start using the gallium (68Ga) chloride solution obtained with GalliaPharm
3. How to use the gallium (68Ga) chloride solution obtained with GalliaPharm
4. Possible side effects
5. Storage of GalliaPharm
6. Package contents and further information

1. What is GalliaPharm and what is it used for

This medicine is a radiopharmaceutical for diagnostic use only.

This medicine is a radiopharmaceutical that must not be administered directly to patients.

GalliaPharm is a germanium (68Ge) / gallium (68Ga) radionuclide generator, a device used to obtain a gallium (68Ga) chloride solution.

The gallium (68Ga) chloride solution is used for radiolabeling, a technique where labeling (radiolabeling) is performed with a radioactive compound, in this case 68Ga.

GalliaPharm is used to label certain medicines that have been developed and approved specifically for use with the active ingredient gallium (68Ga) chloride. These medicines act as carriers to carry the radioactive 68Ga to where it is needed. These may be substances designed to recognize a specific type of cell in the body, including tumor cells (cancer). The small amount of radioactivity administered can be detected outside the body using special cameras to obtain body images. Refer to the package leaflet of the medicine that will be radiolabeled with gallium (68Ga) chloride. Your nuclear medicine doctor will explain what kind of examination will be performed with this product.

Administration of a medicine labeled with 68Ga involves receiving a small amount of radioactivity. Your doctor and nuclear medicine doctor have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical outweighs the risk of radiation.

2. What you need to know before you start using the gallium (68Ga) chloride solution obtained with GalliaPharm

The gallium (68Ga) chloride solution obtained with GalliaPharm must not be administered

• if you are allergic to gallium (68Ga) chloride or any of the other components of this medicine (listed in section 6).

If you are using a medicine labeled with 68Ga, you should read the information on contraindications in the package leaflet of the medicine that will be radiolabeled.

Warnings and precautions

For information related to special warnings and precautions for the use of medicines labeled with 68Ga, refer to the package leaflet of the medicine that will be radiolabeled.

Children and adolescents

Tell your nuclear medicine doctor if you or your child is under 18 years old.

Other medicines and the gallium (68Ga) chloride solution

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

It is not known if the gallium (68Ga) chloride solution can interact with other medicines, as no specific studies have been conducted.

For information related to interactions associated with the use of medicines labeled with 68Ga, refer to the package leaflet of the medicine that will be radiolabeled.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your nuclear medicine doctor before administering medicines labeled with GalliaPharm.

You must inform your nuclear medicine doctor before administration of medicines labeled with GalliaPharm if there is any possibility that you may be pregnant, if you have a delayed period, or if you are breastfeeding.

In case of doubt, it is important that you consult your nuclear medicine doctor who will supervise the procedure.

If you are pregnant

Your nuclear medicine doctor will only administer this medicine during pregnancy if the expected benefit outweighs the risk.

If you are breastfeeding

You will be asked to stop breastfeeding. Ask your nuclear medicine doctor when you can resume breastfeeding.

Driving and using machines

There may be effects on the ability to drive and use machines due to the medicine used in combination with GalliaPharm. Read the package leaflet of that medicine carefully.

3. How to use the gallium (68Ga) chloride solution obtained with GalliaPharm

There are strict rules on the use, handling, and disposal of radiopharmaceuticals. GalliaPharm will only be used in special controlled areas. This product 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 product and will inform you of their actions.

The nuclear medicine doctor who supervises the procedure will decide the amount of medicine labeled with GalliaPharm to be used in your case. This will be the minimum amount necessary to obtain the desired information, depending on the final product and its intended use. For more information, read the package leaflet of the medicine that will be radiolabeled.

Administration of the gallium (68Ga) chloride solution and performance of the procedure

You will not receive the gallium (68Ga) chloride solution, but another product labeled with GalliaPharm. The gallium (68Ga) chloride solution must only be used in combination with another medicine that has been developed and approved specifically for combination (radiolabeling) with GalliaPharm. You will only receive the final labeled product.

Duration of the procedure

Your nuclear medicine doctor will inform you about the usual duration of the procedure after administration of the medicine labeled with GalliaPharm.

After administration of the medicine labeled with GalliaPharm:

Your nuclear medicine doctor will inform you if you need to take special precautions after administration of the medicine labeled with GalliaPharm. Consult your nuclear medicine doctor if you have any doubts.

If you have been administered more medicine labeled with GalliaPharm than you should:

Overdose is unlikely, as you will only receive the medicine labeled with GalliaPharm under the precise control of the nuclear medicine doctor who supervises the procedure. However, in case of overdose, you will receive the appropriate treatment.

If you have any further questions about the use of this product, ask your nuclear medicine doctor who supervises the procedure.

4. Possible side effects

Like all medicines, the medicine labeled with GalliaPharm can cause side effects, although not everybody gets them.

Administration of the medicine labeled with GalliaPharm involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and genetic disorders.

Reporting of side effects

If you experience any side effects, talk to your nuclear medicine doctor, even if they are not listed in this leaflet.

You can also report side effects directly to the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of GalliaPharm

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 for healthcare professionals only.

The radionuclide generator must not be used after the expiry date stated on the packaging after "EXP".

Do not dismantle the box. Do not store above 25°C.

The gallium (68Ga) chloride solution obtained with GalliaPharm must be used immediately.

6. Package contents and further information

Composition of GalliaPharm

The active substance is gallium (68Ga) chloride solution.

The other components are: Titanium dioxide (matrix), Hydrochloric acid 0.1 mol/l sterile ultrapure (elution solution)

Appearance of GalliaPharm and package contents

You will not receive or handle this medicine.

Marketing authorization holder and manufacturer

Eckert & Ziegler Radiopharma GmbH

Robert-Rössle-Str. 10

13125 Berlin

Germany

Local representative:

NUCLIBER, S.A.

C/ Hierro, 33

28045 Madrid

Spain

Tel.: +34 915 062 940

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

Date of last revision of this leaflet: 12/2019.

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This information is intended for healthcare professionals only:

The full technical specifications of GalliaPharm are provided in a separate document in the product packaging, with the aim of providing healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please refer to the technical specifications [the technical specifications must be included in the box].