Galliad 0.74 - 1.85 GBq generator of radionuclide

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Galliad 0.74-1.85 GBq radionuclide generator

Gallium chloride (68Ga) solution

Read the entire leaflet carefully before starting to administer this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to refer to it again.

• If you have any questions, consult the nuclear medicine physician who will supervise the procedure.

• If you experience any adverse reactions, consult your nuclear medicine physician, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Galliad is and what it is used for
2. What you need to know before using the gallium chloride (68Ga) solution obtained with Galliad
3. How to use the gallium chloride (68Ga) solution obtained with Galliad
4. Possible side effects
5. How to store Galliad
6. Contents of the pack and other information

1. What Galliad is and what it is used for

This medicine is a radiopharmaceutical and is not intended for direct administration to patients.

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

The gallium chloride (68Ga) solution obtained is used for radiolabelling, a technique involving the labelling (radiolabelling) of a substance with a radioactive compound—in this case, 68Ga.

Galliad 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. They may include substances designed to target specific types of cells in the body, such as tumour cells (cancer). The small amount of radioactivity administered can be detected outside the body using special cameras.

Please refer to the package leaflet of the medicinal product that will be radiolabelled with gallium chloride (68Ga). The nuclear medicine physician will explain to you what type of imaging procedure will be performed using this product.

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

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

Do not use gallium chloride (68Ga) solution obtained with Galliad:

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

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

Warnings and precautions

For information on warnings and special precautions for the use of 68Ga-labelled medicinal products, please refer to the package leaflet of the medicinal product to be radiolabelled.

Children and adolescents

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

Use of gallium chloride (68Ga) solution with other medicines

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

For further information on interactions associated with the use of 68Ga-labelled medicinal products, please refer to the package leaflet of the medicinal product 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 medicinal products with Galliad.

You must inform your nuclear medicine physician before administration of radiolabelled medicinal products with Galliad if there is any possibility you could be pregnant, if you have missed a menstrual 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

Your nuclear medicine physician will only administer this product during pregnancy if the expected benefit outweighs the potential risks.

If you are breastfeeding

You will be asked to interrupt breastfeeding. Consult your nuclear medicine physician regarding when you may resume breastfeeding.

Driving and using machines

Your ability to drive and operate machinery may be affected by the medicinal product used in combination with Galliad. Please read the package leaflet of that medicinal product carefully.

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

There are strict regulations regarding the use, handling, and disposal of radiopharmaceuticals. Galliad will only be used in specially controlled areas. This product will only be handled and administered by trained and qualified personnel who are skilled in its safe use. These individuals will take particular care to ensure the safe use of this product and will keep you informed of their actions.

The nuclear medicine physician supervising the procedure will determine the amount of radiolabelled medicinal product using Galliad appropriate for your case. This will be the smallest necessary amount required to achieve the desired outcome, depending on the medicinal product to be radiolabelled 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 obtained with Galliad and performance of the procedure

You will not receive the gallium chloride (68Ga) solution itself, but rather another product radiolabelled with Galliad.

The gallium chloride (68Ga) solution must only be used in combination with another medicinal product specifically developed to be combined (radiolabelled) with Galliad. You will only receive the final radiolabelled product.

Duration of the procedure

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

After administration of the radiolabelled medicinal product with Galliad

The nuclear medicine physician will inform you if you need to take any special precautions after receiving the radiolabelled medicinal product with Galliad. Please consult your nuclear medicine physician if you have any questions.

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

An overdose is unlikely, as you will only receive the radiolabelled medicinal product with Galliad in a precisely controlled amount determined by the supervising nuclear medicine physician. Nevertheless, 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 the nuclear medicine physician supervising the procedure.

4. Possible adverse effects

Like all medicines, the Galliad radiolabelled medicine may produce adverse effects, although not everyone will experience them.

Administration of the Galliad radiolabelled medicine involves receiving a small amount of ionizing radiation, with a very low risk of developing cancer and hereditary abnormalities.

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 can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Galliad

This medicine does not need to be stored by the patient. This medicine is stored under the responsibility of a 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 after "EXP".

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

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

6. Pack contents and additional information

Contents of Galliad

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

The other components are:

• titanium dioxide (matrix).
• sterile 0.1 N hydrochloric acid (elution solution).

Appearance of Galliad and pack contents

You will not receive or handle this medicinal product.

Marketing Authorization Holder and Manufacturer

IRE-Elit
Avenue de l'Espérance
B-6220 Fleurus
Belgium

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of latest review of this leaflet: May 2018

This information is intended for medical or healthcare professionals only:

The full Summary of Product Characteristics for Galliad 0.74-1.85 GBq radionuclide generator is provided in a separate document within the product packaging, 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.