GALLIAD 0.74 - 1.85 GBq RADIOPHARMACEUTICAL GENERATOR

Introduction

Package Leaflet: Information for the User

Galliad 0.74-1.85 GBq Radionuclide Generator

Gallium (68Ga) chloride solution

Read all of this leaflet carefully before you start using 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 be supervising 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 Galliad and what is it used for
2. What you need to know before you start using the gallium (68Ga) chloride solution obtained with Galliad
3. How to use the gallium (68Ga) chloride solution obtained with Galliad
4. Possible side effects
5. Storage of Galliad
6. Package Contents and Further Information

1. What is Galliad and what is it used for

This medicine is a radiopharmaceutical that is not intended for direct use in patients.

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

The gallium (68Ga) chloride solution obtained is used for radiolabeling, a technique that involves labeling a substance with a radioactive compound, in this case 68Ga.

Galliad 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 transport the radioactive 68Ga to where it is needed. This may involve substances designed to recognize a specific type of cell in the body, such as cancer cells. The small amount of radioactivity administered can be detected outside the body using special cameras.

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 small amounts of radioactivity. Your doctor and nuclear medicine doctor have considered that the clinical benefit you will gain 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 Galliad

The gallium (68Ga) chloride solution obtained with Galliad must not be used:

• 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 product that will be radiolabeled.

Warnings and Precautions

For information on 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.

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

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

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

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

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your nuclear medicine doctor for advice before you are given medicines labeled with Galliad.

You should inform your nuclear medicine doctor before administration of medicines labeled with Galliad if there is any possibility that you may be pregnant, if you have missed a menstrual period, or if you are breast-feeding.

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

If you are pregnant

Your nuclear medicine doctor will only give you this product during pregnancy if he/she anticipates that the benefit will outweigh the risks.

If you are breast-feeding

You will be asked to interrupt breast-feeding. Ask your nuclear medicine doctor when you can restart breast-feeding.

Driving and Using Machines

Your ability to drive and use machines may be affected due to the medicine used in combination with Galliad. Read the package leaflet of that medicine carefully.

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

There are strict rules for the use, handling, and disposal of radiopharmaceuticals. Galliad will only be used in special controlled areas. This product will only be handled and administered by trained and qualified personnel who are authorized to use it safely. These individuals will take special care to use this product safely and will keep you informed of their actions.

The nuclear medicine doctor supervising the procedure will decide the amount of medicine labeled with Galliad to be used in your case. This will be the smallest amount necessary to achieve the desired result, depending on the medicine to be labeled 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 obtained with Galliad and performance of the procedure

You will not receive the gallium (68Ga) chloride solution as such, but another product labeled with Galliad.

The gallium (68Ga) chloride solution should only be used in combination with another medicine that has been specifically developed for combination (radiolabeling) with Galliad. 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 Galliad.

After administration of the medicine labeled with Galliad

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

If you have been given more medicine labeled with Galliad than you should

Overdose is unlikely since you will only receive the medicine labeled with Galliad under the precise control of the nuclear medicine doctor supervising the procedure. Nevertheless, in case of overdose, you will receive appropriate treatment.

If you have any further questions on the use of this product, ask your nuclear medicine doctor who will be supervising the procedure.

4. Possible Side Effects

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

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

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 Medicines Agency: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Galliad

You will not need to store this medicine. This medicine is stored under the responsibility of a specialist in suitable premises. 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 plastic casing. Do not store above 25°C.

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

6. Package Contents and Further Information

Contents of Galliad

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

The other ingredients are:

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

Appearance of Galliad and Package Contents

You will not receive or handle this medicine.

Marketing Authorization Holder and Manufacturer

IRE-Elit

Avenue de l'Espérance

B-6220 Fleurus

Belgium

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

Date of last revision of this leaflet: May 2018

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This information is intended for healthcare professionals only:

The full summary of product characteristics of Galliad 0.74-1.85 GBq radionuclide generator is 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 summary of product characteristics.