GalliaPharm 0.74 - 1.85 GBq radionuclide generator

Package leaflet: Information for the user

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 are given this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your nuclear medicine physician who will supervise the procedure.
• If you experience any side effects, talk to your nuclear medicine physician, even if they are not listed in this leaflet. See section 4.

Leaflet contents:

1. What GalliaPharm is and what it is used for
2. What you need to know before 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. How to store GalliaPharm
6. Contents of the pack and other information

1. What GalliaPharm is and what it is used for

This medicine is a radiopharmaceutical for diagnostic use only.

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

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

The gallium chloride (68Ga) solution is used for radiolabelling, a technique in which a compound is labelled (radiolabelled) with a radioactive substance, in this case 68Ga.

GalliaPharm is used to radiolabel certain medicinal products that have been specifically developed and approved for use with the active substance gallium chloride (68Ga). These medicinal products act as carriers to deliver the radioactive 68Ga to the required site in the body. These may include substances designed to recognize a specific type of cell in the body, including tumour cells (cancer). The small amount of radioactivity administered can be detected outside the body using special cameras to produce images of the body. Refer to the package leaflet of the medicinal product to be radiolabelled with gallium chloride (68Ga). The nuclear medicine physician will explain to you what type of examination will be performed using this product.

Administration of a medicinal product radiolabelled with 68Ga involves exposure to a small amount of radioactivity. Your doctor and the nuclear medicine physician have determined that the clinical benefit you will receive from the procedure using this radiopharmaceutical outweighs the risk associated with radiation exposure.

2. What you need to know before starting to use gallium chloride (68Ga) solution obtained with GalliaPharm

Do not administer gallium chloride (68Ga) solution obtained with GalliaPharm

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

If you are using a 68Ga-labelled medicine, you must read the information on contraindications in the package leaflet of the medicine to be radiolabelled.

Warnings and precautions

For information regarding special warnings and special precautions for the use of 68Ga-labelled medicines, please refer to the package leaflet of the medicine to be radiolabelled.

Children and adolescents

Inform your nuclear medicine physician if you or your child is under 18 years of age.

Other medicines and gallium chloride (68Ga) solution

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

It is not known whether gallium chloride (68Ga) solution may interact with other medicines, as specific studies have not been conducted.

For information on interactions associated with the use of 68Ga-labelled medicines, consult the package leaflet of the medicine to be radiolabelled.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your nuclear medicine physician before being administered radiolabelled medicines with GalliaPharm.

You must inform the nuclear medicine physician before administration of radiolabelled medicines with GalliaPharm if there is any possibility you may be pregnant, if you have missed your period, or if you are breastfeeding.

If in doubt, it is important to consult your nuclear medicine physician, who will supervise the procedure.

If you are pregnant

The nuclear medicine physician will only administer this medicine during pregnancy if the expected benefit outweighs the potential risk.

If you are breastfeeding

You will be asked to stop breastfeeding. Ask your nuclear medicine physician 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. Please read the package leaflet of that medicine carefully.

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

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. GalliaPharm will be used only in specially controlled areas. This product will be handled and administered only by trained and qualified personnel competent in its safe use. These individuals will take particular care in the safe handling of this product and will inform you about their actions.

The nuclear medicine physician supervising the procedure will determine the amount of radiolabelled medicinal product using GalliaPharm appropriate for your case. This will be the minimum quantity necessary to obtain the required information, depending on the final product and its intended use. For further information, please read the package leaflet of the medicinal product to be radiolabelled.

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

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

Duration of the procedure

Your nuclear medicine physician will inform you about the usual duration of the procedure following administration of the radiolabelled medicinal product with GalliaPharm.

After administration of the radiolabelled medicinal product with GalliaPharm:

Your nuclear medicine physician will inform you whether you need to take any special precautions after receiving the radiolabelled medicinal product with GalliaPharm. Please consult your nuclear medicine physician if you have any doubts.

If you have been administered more radiolabelled medicinal product with GalliaPharm than you should have received

An overdose is unlikely, as you will only receive the radiolabelled medicinal product with GalliaPharm in a precisely controlled amount determined by the supervising nuclear medicine physician. However, in the event of an overdose, appropriate treatment will be administered.

If you have any further questions about the use of this product, please ask your supervising nuclear medicine physician.

4. Possible adverse effects

Like all medicines, the radiolabelled GalliaPharm medicinal product may cause adverse effects, although not everyone will experience them.

Administration of the radiolabelled GalliaPharm medicinal product involves receiving a small amount of ionizing radiation, with a very low risk of developing cancer and hereditary defects.

Reporting of adverse effects

If you experience any type of adverse effect, consult your nuclear medicine physician, even if it is a possible adverse effect not listed in this leaflet.

You may also report adverse effects directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicinal product.

5. Storage of GalliaPharm

You will not be required to store this medicine. This medicine is stored under the responsibility of the specialist in appropriate facilities. Storage of radiopharmaceuticals must comply with national regulations concerning radioactive materials.

The following information is intended for specialists only.

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

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

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

6. Package contents and additional information

Composition of GalliaPharm

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

The other components are: Titanium dioxide (matrix)

Sterile ultrapure hydrochloric acid 0.1 mol/l (elution solution)

Appearance of GalliaPharm and contents of the pack

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

Date of the latest review of this leaflet: 12/2019.

This information is intended for healthcare professionals only:

The full summary of product characteristics for GalliaPharm is provided in a separate document within the product packaging, intended to provide healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please consult the summary of product characteristics [the summary of product characteristics must be included in the package].