Label: information for the user

Galliad 0.74-1.85 GBq radionuclide generator

Gallium chloride solution (68Ga)

Read this label carefully before starting to administer this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult the nuclear physician who will oversee the procedure.

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

1. What is Galliad and how is it used

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

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

4. Possible adverse effects

5. Storage of Galliad

6. Contents of the package and additional information

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

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

The gallium chloride (68Ga) solution obtained is used for radioactive labeling, a technique involving labeling a substance with a radioactive compound, in this case the68Ga.

Galliad is used to label certain medications that have been developed and approved specifically for use with the active principle, gallium chloride (68Ga). These medications act as carriers to transport the68Ga radioactive to the area where it is needed. This may involve substances designed to recognize a specific type of cells in the body, such as cancer cells. The low amount of administered radioactivity can be detected outside the body using special cameras.

Consult the prospectus of the medication to be labeled with gallium chloride (68Ga). The nuclear physician will explain the type of examination to be performed with this product.

The administration of a medication labeled with68Ga involves receiving small amounts of radioactivity. Your doctor and the nuclear physician have considered that the clinical benefit you will obtain from the procedure with the radiopharmaceutical is greater than the risk of radiation.

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

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

If you are using a medication marked with68Ga, you must read the information on contraindications in the prospectus of the product that is going to be radiolabeled.

Warnings and precautions

For information on special precautions for the use of medications marked with68Ga, consult the prospectus of the medication that is going to be radiolabeled.

Children and adolescents

Inform your nuclear physician if you or your child is under 18years old.

Use of the gallium chloride solution (68Ga) with other medications

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

The interaction of gallium chloride (68Ga) with other medications is unknown since specific studies have not been conducted.

For more information on interactions associated with the use of medications marked with68Ga, consult the prospectus of the medication that is going to be radiolabeled.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your nuclear physician before receiving radiolabeled medications with Galliad.

You must inform your nuclear physician before the administration of radiolabeled medications with Galliad if there is any possibility of pregnancy, if you have a menstrual delay, or if you are breastfeeding.

In case of doubt, it is essential to consult your nuclear physician who will supervise the procedure.

If you are pregnant

Your nuclear physician will only administer this product during pregnancy if they foresee a benefit that outweighs the risks.

If you are breastfeeding

You will be asked to stop breastfeeding. Consult your nuclear physician when you can resume breastfeeding.

Driving and operating machines

Your ability to drive and operate machines may be affected due to the medication used in combination with Galliad. Read the prospectus of that medication carefully.

There are strict guidelines for the use, handling, and disposal of radioactive pharmaceuticals. Galliad will only be used in specially controlled areas. Only trained and qualified personnel will handle and administer this product in a safe manner. Those individuals will exercise special care when using this product safely and will keep you informed of their actions.

The nuclear medicine physician overseeing the procedure will decide on the amount of radiolabeled medication obtained with Galliad that should be used in your case. This will be the smallest amount necessary to achieve the desired result, depending on the medication being labeled and its intended use. For more information, read the prospectus of the medication being radiolabeled.

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

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

The gallium chloride solution (68Ga) should only be used in combination with another medication that has been specifically developed to be combined (radiolabeled) with Galliad. You will only receive the final radiolabeled product.

Procedure duration

Your nuclear medicine physician will inform you about the typical duration of the procedure after administration of the radiolabeled medication with Galliad.

After administration of the radiolabeled medication with Galliad

Your nuclear medicine physician will inform you if you need to take any special precautions after receiving the radiolabeled medication with Galliad. Consult your nuclear medicine physician if you have any questions.

If you have been administered more radiolabeled medication with Galliad than you should have

It is unlikely that an overdose will occur, as you will only receive the radiolabeled medication with Galliad precisely controlled by the nuclear medicine physician overseeing the procedure. However, in the event of an overdose, you will receive the appropriate treatment.

If you have any other questions about the use of this product, ask the nuclear medicine physician overseeing the procedure.

Like all medications, the radiolabeled medication with Galliad may produce adverse effects, although not all people may experience them.

The administration of the radiolabeled medication with Galliad involves receiving a small amount of ionizing radiation with a very low risk of developing cancer and hereditary anomalies.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your nuclear physician, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medications for Human Use: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This medication does not need to be stored by the patient. This medication will be stored under the responsibility of the specialist in suitable facilities. Radioisotope storage will be performed in accordance with national regulations on radioactive materials.

The following information is intended solely for the specialist:

The radionuclide generator should not be used after the expiration date appearing on the packaging after "CAD".

Do not disassemble the plastic casing. Do not store at a temperature above 25°C.

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

Content of Galliad

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

The other components are:

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

Appearance of Galliad and contents of the package

You will not receive or handle this medication.

Holder of the marketing authorization and responsible for manufacturing

IRE-Elit

Avenue de l'Espérance

B-6220 Fleurus

Belgium

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

Last review date of this leaflet: May2018

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This information is intended solely for medical professionals or the healthcare sector:

The complete technical file of Galliad 0.74-1.85GBq radionuclide generator, is provided in a separate document in the product packaging, with the aim of facilitating healthcare professionals with additional scientific and practical information on the administration and use of this radiopharmaceutical.

Please refer to the technical file.